The Complete Guide to LIMS

& Laboratory Informatics:

2016 Edition

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PDF generated at: Tue, 19 Jan 2016 15:15:10 CET
Contents
Articles
1. About the Content of This Guide 1
LIMSwiki mission 1

2. Introduction to Informatics in the Laboratory 2

Information 2
Informatics (academic field) 6
Laboratory 10
Laboratory informatics 12

3. Informatics Across Several Industries 14

Bioinformatics 14
Cancer informatics 20
Chemical informatics 23
Environmental informatics 25
Evolutionary informatics 27
Geoinformatics 30
Health informatics 32
Hydroinformatics 38
Imaging informatics 40
Public health informatics 43

4. All about LIMS and LIS 46

Laboratory information management system 46
LIMS feature 52
Laboratory information system 69
LIS feature 72

5. More Laboratory Informatics Applications 90

Chromatography data management system 90
Electronic laboratory notebook 91
Laboratory execution system 94
Scientific data management system 95

6. Related Standards and Compliance 97

 21 CFR Part 11 97
40 CFR Part 3 99
ASTM E1578-13 102
Clinical Laboratory Improvement Amendments 103
Good Automated Laboratory Practices 106
Good Automated Manufacturing Practice 107
Health Insurance Portability and Accountability Act 109
Health Level 7 113
ISO 9000 116
ISO/IEC 17025 119
ISO/TS 16949 122
The American Society of Crime Laboratory Directors/Laboratory Accreditation Board 126
The NELAC Institute 127

7. Laboratory Informatics Resources 129

Laboratory, Scientific, and Health Informatics Buyer's Guide 129
Open-source laboratory informatics software 137
Laboratory informatics consultants 139
21 CFR Part 11: Audit guidelines and checklist 149
Health Insurance Portability and Accountability Act: Audit guidelines and checklist 155
Laboratory information management system (LIMS) questionnaire 159
Laboratory information system (LIS) questionnaire 173

8. Laboratory Informatics Vendor Directory 188

Key laboratory informatics vendors and software 188
LIMS vendor 190
LIS vendor 203
ELN vendor 210
CDMS vendor 214
SDMS vendor 216

References
Article Sources and Contributors 218
Image Sources, Licenses and Contributors 220

Article Licenses
License 222
 1

1. About the Content of This Guide

LIMSwiki mission
The mission and goal of the 'Laboratory Informatics Encyclopedia', otherwise known as LIMSwiki, is to provide the
laboratory community and LIMS community with an organized, documented, up-to-date, standardized body of
knowledge (BoK) regarding all aspects of laboratory informatics, bioinformatics, and health informatics. The value
and success of LIMSwiki (like any community wiki) is dependent upon the laboratory community contributing their
vast knowledge through the creation of relevant articles and editing of existing articles where knowledge is absent.
The explosion of the laboratory and health informatics fields paired with the vast number of LIMS vendors and
products as well as LIMS' increased scope well beyond its original purpose of sample management to just about
all facets of laboratory operations has resulted in a wealth of information not easily comprehended. This potential
confusion frustrates informatics customers and makes the already challenging task of successfully implementing and
managing a LIMS, ELN, or other informatics software even more difficult. In that regard, the Laboratory Informatics
Institute (which is responsible for this wiki) believes the community (including vendors, users, and consultants) will
benefit from a common vocabulary and understanding to facilitate communication, comparison, and product
integration, providing maximum value to buyers and maximum opportunity to vendors and consultants.
 2

2. Introduction to Informatics in the

Laboratory

Information
Information, in its most restricted technical sense, is a sequence of symbols that can be interpreted as a message,
recorded as signs, or transmitted as signals. Conceptually, information is the message (utterance or expression) being
conveyed. Therefore, in a general sense, information is "knowledge communicated or received concerning a
particular fact or circumstance."
From the stance of information theory, information is taken as a sequence of symbols from an alphabet, say an input
alphabet , and an output alphabet . Information processing consists of an input-output function that maps any input
sequence from into an output sequence from . The mapping may be probabilistic or determinate. It may have
memory or be memoryless.
Information cannot be predicted and resolves uncertainty. The uncertainty of an event is measured by its probability
of occurrence and is inversely proportional to that. The more uncertain an event, the more information is required to
resolve uncertainty of that event. The amount of information is measured in bits. The concept that information is the
message has different meanings in different contexts. Thus the concept of information becomes closely related to
notions of constraint, communication, control, data, form, instruction, knowledge, meaning, understanding,
stimulation, pattern, perception, representation, and entropy.

Variations of information

As sensory input
Often information can be viewed as a type of input to an organism or system. Some inputs are important to the
function of the organism (for example, food) or to the system itself (energy) and are called causal inputs. Other
inputs (information) are important only because they are associated with causal inputs and can be used to predict the
occurrence of a causal input at a later time (and perhaps another place). Some information is important because of its
association with other information, but eventually there must be a connection to a causal input.
In practice, information is usually carried by weak stimuli that must be detected by specialized sensory systems and
amplified by energy inputs before they can be functional to the organism or system. For example, light is often a
causal input to plants but provides information to animals. The colored light reflected from a flower is too weak to
do much photosynthetic work. However, the visual system of the bee detects it, and the bee's nervous system uses
the information to guide the bee to the flower, where the bee often finds nectar or pollen, causal inputs serving a
nutritional function.

As representation and complexity

One theory says information is a concept that involves at least two related entities in order to make quantitative
sense: a dimensionally defined category of objects "S" and any of its subsets "R". In essence "R" is a representation
of "S"; it conveys representational (and hence, conceptual) information about "S". The amount of information that
"R" conveys about "S" is equivalent to the rate of change in the complexity of "S" whenever the objects in "R" are
removed from "S". Under this theory, the universal scientific constructs of pattern, invariance, complexity,
representation, and information are unified under a novel mathematical framework. Among other things, the
Information 3

framework aims to overcome the limitations of Shannon-Weaver information when attempting to characterize and
measure subjective information.

As an influence which leads to a transformation

Information can also be defined as any type
of pattern that influences the formation or
transformation of other patterns. In this
sense, there is no need for a conscious mind
to perceive, much less appreciate, the
pattern. Consider, for example, DNA. The
sequence of nucleotides is a pattern that
influences the formation and development
of an organism without any need for a
conscious mind.
Systems theory at times seems to refer to
information in this sense, assuming
information does not necessarily involve
any conscious mind, and patterns circulating
(due to feedback) in the system can be
called information. In other words, it can be
said information in this sense is something
potentially perceived as representation,
though not created or presented for that Visual representation of the relationship between language, data/facts, information,
purpose. For example, anthropologist and and knowledge
social scientist Gregory Bateson defined
"information" as a "difference that makes a difference."
If, however, the premise of "influence" implies that information has been perceived by a conscious mind and also
interpreted by it, the specific context associated with this interpretation may cause the transformation of the
information into knowledge. Complex definitions of both "information" and "knowledge" make such semantic and
logical analysis difficult, but the condition of "transformation" is an important point in the study of information as it
relates to knowledge, especially in the business discipline of knowledge management. In this practice, tools and
processes are used to assist a knowledge worker in performing research and making decisions, including steps such
as:
reviewing information in order to effectively derive value and meaning
referencing metadata if any is available
establishing a relevant context, often selecting from many possible contexts
deriving new knowledge from the information
making decisions or recommendations from the resulting knowledge
The Danish Dictionary of Information Terms suggests, however, information only provides an answer to a posed
question. Whether the answer provides knowledge depends on the informed person. Thus a generalized definition of
the transformation concept could be "information represents the answer to a specific question."
Information 4

As a property in physics
Information has had a well-defined meaning in physics. However, in 2003 theoretical physicist J. D. Bekenstein
claimed a growing trend in physics was to define the physical world as being made up of information itself.
Examples of this include the phenomenon of quantum entanglement, where particles can interact without reference
to their separation or the speed of light. Information itself cannot travel faster than light, even if the information is
transmitted indirectly. This could lead to all attempts at physically observing a particle with an "entangled"
relationship to another being slowed down, even though the particles are not connected in any other way other than
by the information they carry.
Another link is demonstrated by the Maxwell's demon thought experiment. In this experiment, a direct relationship
between information and another physical property, entropy, is demonstrated. As a result, destroying the information
is impossible without increasing the entropy of a system; in practical terms this often means generating heat.

As records
Records are specialized forms of information, produced consciously or as by-products of business activities or
transactions and retained because of their value. Organizations value records as evidence of activity, but they may
also be retained for their informational value. Sound records management ensures the integrity of records is
preserved for as long as they are required.
The international standard on records management, ISO 15489, defines records as "information created, received,
and maintained as evidence and information by an organization or person, in pursuance of legal obligations or in the
transaction of business."
The International Committee on Archives (ICA), Committee on Electronic Records defined a record as "recorded
information produced or received in the initiation, conduct, or completion of an institutional or individual activity
and that comprises content, context, and structure sufficient to provide evidence of the activity."
Records may be maintained to retain corporate memory of the organization or to meet legal, fiscal, or accountability
requirements imposed on the organization. In 2005 legal expert Anthony Willis elaborated on this view, stating the
sound management of business records and information delivered "...six key requirements for good corporate
governance ... transparency; accountability; due process; compliance; meeting statutory and common law
requirements; and security of personal and corporate information."

Technologically mediated information

In 2011 scientists Martin Hilbert and Priscila Lpez estimated the world's technological capacity to store information
grew from 2.6 (optimally compressed) exabytes in 1986 which is the informational equivalent to less than one
730-MB CD-ROM per person (539 MB per person) to 295 (optimally compressed) exabytes in 2007. This is the
informational equivalent of almost 61 CD-ROM per person in 2007.
Hilbert and Lpez also stated the world's combined technological capacity to receive information through one-way
broadcast networks was the informational equivalent of 174 newspapers per person per day in 2007., while the
world's combined effective capacity to exchange information through two-way telecommunication networks was the
informational equivalent of six newspapers per person per day.
Information 5

Information and semiotics

Scientists can also explain information in terms of signs and signal-sign systems. Signs themselves can be considered
in terms of four interdependent levels, layers, or branches of semiotics: pragmatics, semantics, syntax, and empirics.
These four layers serve to connect the social world with the physical or technical. The four branches of semiotics are
described as such:
1. pragmatics: the purpose of communication - Pragmatics links the issue of signs with the context within which
signs are used. The focus of pragmatics is on the intentions of living agents underlying communicative behavior.
In other words, pragmatics links language to action.
2. semantics: the meaning of a message conveyed in a communicative act - Semantics considers the content of
communication, the meaning of signs, and the association between signs and behavior. The study of semantics
links symbols and their referents or concepts, particularly the way in which signs relate to human behavior.
3. syntax: the formalism used to represent a message - Syntax considers the form of communication in terms of the
logic and grammar of sign systems. Syntax focuses on form rather than the content of signs and sign systems.
4. empirics: the signals used to carry a message - Emperics focus on the physical characteristics of the medium of
communication. Empirics is devoted to the study of communication channels and their characteristics, e.g., sound,
light, electronic transmission, etc.
In 2008, lexicographer Sandro Nielsen discussed the relationship between semiotics and information in relation to
dictionaries. The concept of lexicographic information costs is introduced and refers to the efforts users of
dictionaries need to make in order to, first, find the data sought and, secondly, understand the data so they can
generate information.
Communication normally exists within the context of some social situation. The social situation sets the context for
the intentions conveyed (pragmatics) and the form in which communication takes place. We express out intentions
through a mutually understood collection of inter-related signs. Mutual understanding implies agents involved
understand the chosen language in terms of its agreed syntax (syntactics) and semantics. The sender codes the
message in the language and sends the message as signals along some communication channel (empirics). The
chosen communication channel will have inherent properties which determine outcomes such as the speed with
which communication can take place and over what distance.

Further reading
Floridi, Luciano (2010). Information - A Very Short Introduction [1]. Oxford University Press. pp.130. ISBN
[2]
0199551375.
Floridi, Luciano. Zalta, Edward N. ed. Semantic Conceptions of Information [3] (Spring 2013 ed.). Stanford
University.
Frieden, B. Roy (20 August 2012). "Fisher Information, a New Paradigm of Science" [4]. Optical Sciences Center,
Univ. of Arizona.
Von Baeyer, Hans Christian (2004). Information: The New Language of Science [5]. Harvard University Press.
pp.258. ISBN [2]0674013875.
Young, Paul (1987). The Nature of Information [6]. Praeger. pp.192. ISBN [2]0275926982.
Information 6

External links
Informationsordbogen.dk [7], the Danish Dictionary of Information Terms / Informationsordbogen

Notes
Some elements of this article are reused from the Wikipedia article [8].

References
[1] http:/ / books. google. com/ books?id=VupFqa3IJiUC
[2] http:/ / en. wikipedia. org/ wiki/ International_Standard_Book_Number
[3] http:/ / plato. stanford. edu/ entries/ information-semantic/
[4] http:/ / fp. optics. arizona. edu/ frieden/ fisher_information. htm
[5] http:/ / books. google. com/ books?id=QpuZgAR8DJwC
[6] http:/ / books. google. com/ books?id=yX9QAAAAMAAJ
[7] http:/ / www. informationsordbogen. dk
[8] http:/ / en. wikipedia. org/ wiki/ Information

Informatics (academic field)

Informatics is the science of information, the practice of
information processing, and the engineering of
information systems. Informatics studies the structure,
algorithms, behavior, and interactions of natural and
artificial systems that store, process, access, and
communicate information. It also develops its own
conceptual and theoretical foundations and utilizes
foundations developed in other fields. Since the advent of
computers, individuals and organizations increasingly
process information digitally. This has led to the study of
informatics that has computational, cognitive, and social
aspects, including study of the social impact of A computer used at China's 2002 National Olympiad in
information technologies. Informatics

While the field of informatics encompasses the study of

systems that represent, process, and communicate information, the theory of computation in the specific discipline of
theoretical computer science which evolved from Alan Turing studies the notion of a complex system regardless of
whether information actually exists. Since both fields process information, there is some disagreement among
scientists as to field hierarchy. For example, Arizona State University attempted to adopt a broader definition of
informatics to even encompass cognitive science at the launch of its School of Computing and Informatics in
September 2006.
The confusion arises since information can be easily stored on a computer, and hence informatics could be
considered the parent of computer science. However, the original notion of a computer was the name given to the
action of computation regardless of the existence of information or the existence of a Von Neumann architecture.
Humans are examples of computational systems and not information systems. Many fields such as quantum
computing theory are studied in theoretical computer science but not related to informatics.
A practitioner of informatics may be called an informatician or an informaticist.
Informatics (academic field) 7

Etymology
In 1957 the German computer scientist Karl Steinbuch coined the word Informatik by publishing a paper called
Informatik: Automatische Informationsverarbeitung ("Informatics: Automatic Information Processing"). The English
term informatics is sometimes understood as meaning the same as computer science. However, the German word
Informatik is the correct translation of the English phrase computer science. (The naming for computer science is
derived from the concept of computation, which may or may not involve the existence of information. For example,
quantum computation and digital logic do not involve information.)
The French term informatique was coined in 1962 by Philippe Dreyfus together with various translations
informatics (English), also proposed independently and simultaneously by Walter F. Bauer and associates who
co-founded Informatics Inc., and informatica (Italian, Spanish, Romanian, Portuguese, Dutch), referring to the
application of computers to store and process information. The term was coined as a combination of "information"
and "automatic" to describe the science of automating information interactions.
The morphologyinformat-ion + -icsuses "the accepted form for names of sciences, as conics, linguistics, optics,
or matters of practice, as economics, politics, tactics", and so, linguistically, the meaning extends easily to
encompass both the science of information and the practice of information processing.

History
This new term was adopted across Western Europe, and, except in English, developed a meaning roughly translated
by the English "computer science" or "computing science." Mikhailov et al. advocated the Russian term informatika
(1966), and the English informatics (1967), as names for the theory of scientific information and argued for a broader
meaning, including study of the use of information technology in various communities and of the interaction of
technology and human organizational structures:
Informatics is the discipline of science which investigates the structure and properties (not specific content) of
scientific information, as well as the regularities of scientific information activity, its theory, history,
methodology and organization.
Usage has since modified this definition in three ways. First, the restriction to scientific information is removed, as in
business informatics or legal informatics. Second, since most information is now digitally stored, computation is
now central to informatics. Third, the representation, processing and communication of information are added as
objects of investigation, since they have been recognized as fundamental to any scientific account of information.
Taking information as the central focus of study, then, distinguishes informatics, which includes the study of
biological and social mechanisms of information processing, from computer science, where digital computation
plays a distinguished central role. Similarly, in the study of representation and communication, informatics is
indifferent to the substrate that carries information. For example, it encompasses the study of communication using
gesture, speech and language, as well as digital communications and networking.
The first example of a degree-level qualification in informatics occurred in 1982 when Plymouth Polytechnic (now
the University of Plymouth) offered a four-year BSc (honours) degree in "Computing and Informatics," with an
initial intake of only 35 students. The course still runs today, making it the longest available qualification in the
subject.[citation needed]
In 1989, the first International Olympiad in Informatics (IOI) a competition of the brightest informatics students
around the world was held in Bulgaria. The competition involved two days of intense competition, with up to four
students selected from each participating country to attend and compete for the highest score on a variety of
informatics problems.
Informatics (academic field) 8

Changing definitions
The definition of informatics has seen many variations across different institutions:
The 2008 Research Assessment Exercise, of the U.K. Funding Councils, includes a new Computer Science and
Informatics unit of assessment (UoA), the scope of which is described as follows:
The UoA includes the study of methods for acquiring, storing, processing, communicating and reasoning
about information, and the role of interactivity in natural and artificial systems, through the implementation,
organisation and use of computer hardware, software and other resources. The subjects are characterised by
the rigorous application of analysis, experimentation and design.
At the Indiana University School of Informatics and Computing in Indianapolis and Southeast, informatics is
defined as "the art, science and human dimensions of information technology" and "the study and application of
information technology to the arts, science and professions." These definitions are generally accepted in the
United States and differ from British usage in omitting the study of natural computation.
At the University of California, Irvine, informatics is defined thusly:
Informatics is based on recognizing that the design of this technology is not solely a technical matter, but must
focus on the relationship between the technology and its use in real-world settings. That is, informatics
designs solutions in context, and takes into account the social, cultural and organizational settings in which
computing and information technology will be used.
At the University of Michigan, Ann Arbor, defines it as a "coupling [of] information with computing technology,"
adding:
Informatics provides solid grounding in computer programming, mathematics, and statistics, combined with
study of the ethical and social science aspects of complex information systems. Informatics majors learn to
critically analyze various approaches to processing information and develop skills to design, implement, and
evaluate the next generation of information technology tools.

Applications of informatics
In the English-speaking world the term informatics was first widely used in the applied sense as "medical
informatics," taken to include "the cognitive, information processing, and communication tasks of medical practice,
education, and research, including information science and the technology to support these tasks." Many such
compounds are now in use; they can be viewed as different areas of applied informatics.
In the 2000s, a major area of applied informatics is that of organizational informatics. Organizational informatics is
fundamentally interested in the application of information, information systems and ICT within organizations of
various forms, including private sector, public sector, and voluntary sector organizations. As such, organizational
informatics can be seen to be sub-category of social informatics and a super-category of business informatics.
By 2004, the field of laboratory informatics the specialized application of information technology to optimize and
extend laboratory operations began emerging as a more distinct area of applied informatics.
Informatics (academic field) 9

Contributing disciplines
Computer science
Communication studies
Complex systems
Didactics of informatics
Information science
Information theory
Information technology

Further reading
Gammack, John; Valerie Hobbs; Diarmuid Pigott (2011). The Book of Informatics [1] (1st Revised ed.). Cengage
Learning. pp.548. ISBN [2]0170216004.
Fourman, Michael (2002) (PDF). Informatics: Informatics Research Report EDI-INF-RR-0139 [2]. University of
Edinburgh. pp.9.
Bauer, Walter F. (1996). "Informatics and (et) Informatique" [3]. IEEE Annals of the History of Computing
(Institute of Electrical and Electronics Engineers) 18 (2). Archived from the original [4] on 20 November 2010.

External links
Council of European Professional Informatics Societies (CEPIS) [5]

References
[1] http:/ / books. google. com/ books?id=MOIW12eOvJsC
[2] http:/ / www. inf. ed. ac. uk/ publications/ online/ 0139. pdf
[3] http:/ / web. archive. org/ web/ 20101120212846/ http:/ / www. softwarehistory. org/ history/ Bauer1. html
[4] http:/ / www. softwarehistory. org/ history/ Bauer1. html
[5] http:/ / www. cepis. org
Laboratory 10

Laboratory
A laboratory is a building, part of a
building, or other place equipped to
conduct scientific experiments, tests,
investigations, and practice within one
or multiple fields of study. This may
also be referred to as a science
laboratory or research laboratory.
Such labs take many forms because of
the differing requirements of
specialists in the various fields of
science and research. For example, a
physics lab might contain a particle
accelerator or vacuum chamber, while
a metallurgy lab could have an
Biomedical Engineering Laboratory at UC Davis College of Engineering
apparatus for casting or refining metals
or for testing their strength. A chemist
or biologist might use a wet laboratory, while a psychologist's lab might be a room with one-way mirrors and hidden
cameras in which to observe behavior.

Despite the great differences among laboratories, some features are common. The use of workbenches or countertops
at which the scientist may choose to either sit or stand is a common way to ensure comfortable working conditions.
Cabinets for the storage of laboratory equipment are also quite common. Scientists have traditionally recorded an
experiment's progress in a laboratory notebook, but modern labs almost always contain at least one computer
workstation for data collection and analysis, utilizing tools like laboratory information management systems (LIMS)
or electronic laboratory notebooks (ELN).
Scientific laboratories can be found in schools and universities, in industry, in government or military facilities, and
even aboard ships and spacecraft. A laboratory might offer work space for just one to more than 30 researchers
depending on its size and purpose. Recently, a new type of laboratory called an "open laboratory" has emerged. Its
format allows the sharing of space, equipment, and support staff among different students and research groups, and it
also fosters information exchange through communications across fields. Current examples include the Electrical
and Computer Engineering Lab at Temple University and all the laboratories at The Mechanobiology Institute of
Singapore.

Types of laboratories
Scientific or research laboratories are as diverse as there are specialties. However, the title of laboratory is also used
for certain other facilities where the processes or equipment used are similar to those in scientific laboratories. These
notably include:
medical lab
public health lab
forensic lab used to process crime scene evidence
computer lab
media lab
film laboratory or darkroom
clandestine lab for the production of illegal drugs
Laboratory 11

In recent years government and private centers for innovation in learning, leadership, and organization have also
adopted "lab" in their name to emphasize the experimental and research-oriented nature of their work.

Laboratory safety
In some laboratories, the conditions are no
more dangerous than in any other room. In
many labs, though, hazards are present.
Laboratory hazards are as varied as the
subjects of study in laboratories, and might
include poisons; infectious agents;
flammable, explosive, or radioactive
materials; moving machinery; extreme
temperatures; lasers; strong magnetic fields;
or high voltage. In laboratories where
dangerous conditions might exist, safety
precautions are important. Rules exist to
minimize the individual's risk, and safety
equipment is used to protect the lab user Examples of safety equipment in the laboratory
from injury or to assist in responding to an
emergency.
In the laboratory regular inspections and audits help assess hazards due to chemical handling and storage, electrical
equipment, biohazards, hazardous waste management, housekeeping and emergency preparedness, radiation safety,
ventilation, and air quality. An important element of such audits is the review of regulatory compliance and the
training of individuals who have access to and/or work in the laboratory. Training is critical to the ongoing safe
operation of the laboratory facility. Educators, staff and management must be engaged in working to reduce the
likelihood of accidents, injuries, and potential litigation. Training may include laboratory safety videos that are both
relevant and engaging.

Standards and guidance

The following entities create standards and guidance for laboratory safety around the world:
American National Standards Institute (ANSI)
Clinical and Laboratory Standards Institute (CLSI) [1]
International Electrotechnical Commission (IEC)
International Organization for Standardization (ISO)
National Institute for Occupational Safety and Health (NIOSH)
Occupational Safety and Health Administration (OSHA) [2]
Laboratory 12

Notes
Some elements of this article are reused from the Wikipedia article [3].

References
[1] http:/ / www. clsi. org/ standards/ about-our-standards/ standards-resources/
[2] https:/ / www. osha. gov/ SLTC/ laboratories/ standards. html
[3] http:/ / en. wikipedia. org/ wiki/ Laboratory

Laboratory informatics
Laboratory informatics is the specialized application of information
through a platform of instruments, software, and data management
tools that allow scientific data to be captured, migrated, processed, and
interpreted for immediate use, as well as stored, managed, and shared
to support future research, development, and lab testing efforts while
maximizing the efficiency of laboratory operations.

The term "laboratory informatics" has been in use at least since the
early 1980s and has expanded in meaning since then. Before the advent
of computer technology, information management played an important
role in laboratories and research efforts of all sorts. And while today
the process of information management continues to be important,
An Eppendorf thermal cycler as an example of a
laboratory informatics tends to focus more on the technology
laboratory device that measures, processes, and
associated with that information management process. sends information

The field itself is one which has seen significant growth as demand for
fast and efficient electronic data exchange has boomed. A rapid series of technological developments have made
laboratory equipment less static and more interactive, allowing large networks of integrated lab devices, computers,
and telecommunications equipment to log, analyze, and distribute data. This has progressively enabled scientific
research projects to move from a localized model to a more global model, one that allows "involved researchers to
spend less time collecting data or waiting for information to arrive from another location, which in turn allows them
to focus more on the work at hand and makes their research both faster and more efficient." This has led to
laboratories requiring more robust and scalable data management systems to stay competitive. The rapid rate of
change in the technological and environmental needs of researchers coupled with growing competition has led
to the creation of conferences like the IQPC Forum on Laboratory Informatics to help directors, managers, and
researchers better keep up with the industry.

Sub-elements in laboratory informatics

Laboratory informatics is often modeled as a central component or hub for other branching elements of the field.
However, looking at the architecture in this fashion oversimplifies the field of laboratory informatics and risks giving
the false appearance that branched elements of the field have greater importance than others. Instead, a
multi-layered, non-hierarchical model of these elements that places an emphasis on an individual laboratory's
identified business needs may be more appropriate. A cottage industry of businesses and consultants has developed
from this philosophy, helping laboratories map their informatics needs to their corporate strategy.
Yet it's difficult to deny the existence of branching elements of laboratory informatics. Many scientific pursuits
require a laboratory, from medicine to astrophysics. This has led to special "sub-applications" of informatics to more
Laboratory informatics 13

specialized laboratories. Genome informatics developed as genetics laboratories sought more efficient ways to
manage the large amounts of data being acquired from experiments and research. As scientists continue their pursuit
of unlocking the secrets of the brain, neuroinformatics and its associated technology has developed to aid those
researchers in their endeavors. And as hydrologists tackle the issues of equitable and efficient use of water for many
different purposes, hydroinformatics and computational hydraulics have emerged.

Technology of laboratory informatics

Important hardware and software systems that play a role in laboratory informatics include but are not limited to:
Chromatography data management systems (CDMS)
Electronic laboratory notebooks (ELN)
Enterprise content management applications (ECM)
Enterprise resource planning applications (ERP)
Laboratory execution systems (LES)
Laboratory information management systems (LIMS)
Laboratory information systems (LIS)
Manufacturing enterprise systems (MES)
Process analytical technology (PAT)
Scientific data management systems (SDMS)

References
 14

3. Informatics Across Several Industries

Bioinformatics
Bioinformatics is the application of
computer science and information
technology to the field of biology, with a
primary goal of understanding biological
processes. What sets it apart from other
approaches, however, is its focus on
developing and applying computationally
intensive techniques (e.g. pattern
recognition, data mining, machine learning
algorithms, and visualization) to achieve this
goal. Major research efforts in the field
include sequence alignment, gene finding,
genome assembly, drug design, drug
Female laboratory technician sitting at computer that displays a microarray; DNA
discovery, protein structure alignment, microarray technology aids in gene expression analysis and other bioinformatics
protein structure prediction, prediction of functions.
gene expression and proteinprotein
interactions, genome-wide association studies, and the modeling of evolution.

The term "bioinformatics" was coined by Paulien Hogeweg and Ben Hesper in 1978 for "the study of informatic
processes in biotic systems." Its primary use since at least the late 1980s has been in genomics and genetics,
particularly in those areas of genomics involving large-scale DNA sequencing. However, rapid developments in
genomic, molecular research, and information technologies have combined to produce a tremendous amount of
information related to molecular and other types of biology. Bioinformatics now entails the creation and
advancement of databases, algorithms, computational, and statistical techniques and theory to solve formal and
practical problems arising from the management and analysis of biological data.

Common activities in bioinformatics include mapping and analyzing DNA and protein sequences, aligning different
DNA and protein sequences to compare them, and creating and viewing 3-D models of protein structures.

History
Arguably one of the first "bioinformatics" projects though the concept didn't yet exist involved the 1965
creation and maintenance of a protein sequence database called the Atlas of Protein Sequence and Structure by
Margaret O. Dayhoff, Richard V. Eck, and Robert S. Ledley. The work grew out of their "biochemical investigation
of the relations between the structures and function of proteins and the theoretical attempt to decipher the genetic
code." Six years later the Brookhaven National Laboratory and the Cambridge Crystallographic Data Centre jointly
created the Protein Data Bank, intended as a public database of three-dimensional protein structures.
The work at Brookhaven would go on to influence others in the field to contribute, with 23 structures contributed in
1976, breaking 5,000 by the end of 1996 and 40,000 in 2006. The significant growth in contributions was fueled by
several events, including: Peter Y. Chou and Gerald D. Fasman's 1974 creation (and later, refinement) of a protein
structure prediction algorithm; David J. Lipman and William R. Pearson's 1985 development (and later, refinement)
Bioinformatics 15

of FASTP (later FASTA) as well as Stephen Altschul and company's 1990 development and refinement of BLAST,
both database sequence searching algorithms and programs; and the formal start of the Human Genome Project in
1990.
A flurry of genome studies went on to produce unprecedented amounts of biological data, creating a sudden demand
for rapid and efficient computational tools to manage and analyze the data. "The development of these computational
tools depended on knowledge generated from a wide range of disciplines including mathematics, statistics, computer
science, information technology, and molecular biology." The merger of these disciplines largely went on to form
what is now known as bioinformatics.

Bioinformatics vs. computational biology

In order to study how normal cellular activities are altered in different disease states, biological data must be
combined to form a comprehensive picture of these activities. Therefore, the field of bioinformatics has evolved such
that the most pressing task now involves the analysis and interpretation of various types of data, including nucleotide
and amino acid sequences, protein domains, and protein structures. However, the related field of computational
biology differs slightly from bioinformatics. Jin Xiong, author of Essential Bioinformatics, describes the differences
between the two as such:
Bioinformatics is limited to sequence, structural, and functional analysis of genes and genomes and their
corresponding products and is often considered computational molecular biology. However,
computational biology encompasses all biological areas that involve computation. For example,
mathematical modeling of ecosystems, population dynamics, application of the game theory in
behavioral studies, and phylogenetic construction using fossil records all employ computational tools,
but do not necessarily involve biological macromolecules.

Major research areas

Sequence analysis
Since the Phage -X174 was sequenced in 1977, the DNA sequences of thousands of organisms have been decoded
and stored in databases. This sequence information is analyzed to determine genes that encode polypeptides
(proteins), RNA genes, regulatory sequences, structural motifs, and repetitive sequences. A comparison of genes
within a species or between different species can show similarities between protein functions, or relations between
species (the use of molecular systematics to construct phylogenetic trees). With the growing amount of data, it long
ago became impractical to analyze DNA sequences manually. Today, computer programs such as BLAST are used
daily to search sequences from more than 260,000 organisms, containing over 190 billion nucleotides. These
programs can compensate for mutations (exchanged, deleted, or inserted bases) in the DNA sequence, to identify
sequences that are related, but not identical. A variant of this sequence alignment is used in the sequencing process
itself. The so-called shotgun sequencing technique which was used, for example, by The Institute for Genomic
Research to sequence the first bacterial genome, Haemophilus influenzae does not produce entire chromosomes,
but instead generates the sequences of many thousands of small DNA fragments (ranging from 35 to 900 nucleotides
long, depending on the sequencing technology). The ends of these fragments overlap and, when aligned properly by
a genome assembly program, can be used to reconstruct the complete genome. Shotgun sequencing yields sequence
data quickly, but the task of assembling the fragments can be quite complicated for larger genomes. For a genome as
large as the human genome, it may take many days of CPU time on large-memory, multiprocessor computers to
assemble the fragments, and the resulting assembly will usually contain numerous gaps that have to be filled in later.
Shotgun sequencing is the method of choice for virtually all genomes sequenced today, and genome assembly
algorithms are a critical area of bioinformatics research.
Bioinformatics 16

Another aspect of bioinformatics in sequence analysis is annotation, which involves computational gene finding to
search for protein-coding genes, RNA genes, and other functional sequences within a genome. Not all of the
nucleotides within a genome are part of genes. Within the genome of higher organisms, large parts of the DNA do
not serve any obvious purpose. This so-called junk DNA may, however, contain unrecognized functional elements.
Bioinformatics helps to bridge the gap between genome and proteome projects, as in the use of DNA sequences for
protein identification.

Gene expression analysis

The expression of many genes can be determined by measuring mRNA levels with multiple techniques including
microarrays, expressed cDNA sequence tag (EST) sequencing, serial analysis of gene expression (SAGE) tag
sequencing, massively parallel signature sequencing (MPSS), RNA-Seq (also known as "Whole Transcriptome
Shotgun Sequencing" (WTSS)), or various applications of multiplexed in-situ hybridization. All of these techniques
are extremely noise-prone and/or subject to bias in the biological measurement, and a major research area in
computational biology involves developing statistical tools to separate signal from noise in high-throughput gene
expression studies. Such studies are often used to determine the genes implicated in a disorder: one might compare
microarray data from cancerous epithelial cells to data from non-cancerous cells to determine the transcripts that are
up-regulated and down-regulated in a particular population of cancer cells.

Regulation analysis
Regulation is the complex orchestration of events starting with an extracellular signal such as a hormone and leading
to an increase or decrease in the activity of one or more proteins. Bioinformatics techniques have been applied to
explore various steps in this process. For example, promoter analysis involves the identification and study of
sequence motifs in the DNA surrounding the coding region of a gene. These motifs influence the extent to which that
region is transcribed into mRNA. Expression data can be used to infer gene regulation: one might compare
microarray data from a wide variety of states of an organism to form hypotheses about the genes involved in each
state. In a single-cell organism, one might compare stages of the cell cycle, along with various stress conditions (heat
shock, starvation, etc.). One can then apply clustering algorithms to that expression data to determine which genes
are co-expressed. For example, the upstream regions (promoters) of co-expressed genes can be searched for
over-represented regulatory elements.

Protein expression analysis

Protein microarrays and high-throughput mass spectrometry can provide a snapshot of the proteins present in a
biological sample. Bioinformatics is very much involved in making sense of protein microarray and mass
spectrometry data; the former approach faces similar problems as with microarrays targeted at mRNA, the latter
involves the problem of matching large amounts of mass data against predicted masses from protein sequence
databases, and the complicated statistical analysis of samples where multiple, but incomplete peptides from each
protein are detected.

Cancer mutation analysis

In cancer, the genomes of affected cells are rearranged in complex or even unpredictable ways. Massive sequencing
efforts are used to identify previously unknown point mutations in a variety of genes in cancer. Bioinformaticians
continue to produce specialized automated systems to manage the sheer volume of sequence data produced, and they
create new algorithms and software to compare the sequencing results to the growing collection of human genome
sequences and germline polymorphisms. New physical detection technologies are employed, such as oligonucleotide
microarrays to identify chromosomal gains and losses (called comparative genomic hybridization), and
single-nucleotide polymorphism arrays to detect known point mutations. These detection methods simultaneously
Bioinformatics 17

measure several hundred thousand sites throughout the genome, and when used in high-throughput to measure
thousands of samples, generate terabytes of data per experiment. The data is often found to contain considerable
variability, or noise, and thus hidden Markov model and change-point analysis methods are being developed to infer
real copy number changes.

Genome annotation
In the context of genomics, annotation is the process of marking the genes and other biological features in a DNA
sequence. The first genome annotation software system was designed in 1995 by Dr. Owen White, who was part of
the team at The Institute for Genomic Research that sequenced and analyzed the first genome of a free-living
organism to be decoded, the bacterium Haemophilus influenzae. Dr. White built a software system to find the genes
(places in the DNA sequence that encode a protein), the transfer RNA, and other features, and to make initial
assignments of function to those genes. Most current genome annotation systems work similarly, but the programs
available for analysis of genomic DNA are constantly changing and improving.

Comparative and computational genomics

The core of comparative genome analysis is the establishment of the correspondence between genes (orthology
analysis) or other genomic features in different organisms. It is these intergenomic maps that make it possible to
trace the evolutionary processes responsible for the divergence of two genomes. A multitude of evolutionary events
acting at various organizational levels shape genome evolution. At the lowest level, point mutations affect individual
nucleotides. At a higher level, large chromosomal segments undergo duplication, lateral transfer, inversion,
transposition, deletion and insertion. Ultimately, whole genomes are involved in processes of hybridization,
polyploidization and endosymbiosis, often leading to rapid speciation. The complexity of genome evolution poses
many exciting challenges to developers of mathematical models and algorithms, who have recourse to a spectra of
algorithmic, statistical, and mathematical techniques. Examples range from exact, heuristics, fixed-parameter, and
approximation algorithms for problems based on parsimony models to Markov Chain Monte Carlo algorithms for
Bayesian analysis of problems based on probabilistic models.

Biological systems modeling

Systems biology involves the use of computer simulations of cellular subsystems (such as the networks of
metabolites and enzymes which comprise metabolism, signal transduction pathways, and gene regulatory networks)
to both analyze and visualize the complex connections of these cellular processes. Artificial life or virtual evolution
attempts to understand evolutionary processes via the computer simulation of simple (artificial) life forms.

Computational evolutionary biology

Evolutionary biology is the study of the origin and descent of species, as well as their change over time. Informatics
has assisted evolutionary biologists in several key ways, enabling researchers to:
trace the evolution of a large number of organisms by measuring changes in their DNA, rather than through
physical taxonomy or physiological observations alone.
compare entire genomes, which permits the study of more complex evolutionary events, such as gene duplication,
horizontal gene transfer, and the prediction of factors important in bacterial speciation.
build complex computational models of populations to predict the outcome of the system over time.
track and share information on an increasingly large number of species and organisms.
The area of research within computer science that uses genetic algorithms is sometimes confused with computational
evolutionary biology, but the two areas are not necessarily related.
Bioinformatics 18

Literature analysis
The sheer amount of published literature makes it virtually impossible to read every paper, resulting in disjointed
subfields of research. Literature analysis aims to employ computational and statistical linguistics to mine this
growing library of text resources. For example:
abbreviation recognition - identify the long-form and abbreviation of biological terms
named entity recognition - recognizing biological terms such as gene names
protein-protein interaction - identify which proteins interact with which proteins from text
The area of research uses statistics and computational linguistics, and is substantially influenced by them.

Structural bioinformatic approaches

Prediction of protein structure

Protein structure prediction is another important
application of bioinformatics. The amino acid
sequence of a protein, the so-called primary
structure, can be easily determined from the sequence
on the gene that codes for it. In the vast majority of
cases, this primary structure uniquely determines a
structure in its native environment. (Of course, there
are exceptions, such as the bovine spongiform
encephalopathy (a.k.a. Mad Cow Disease) prion.)
Knowledge of this structure is vital in understanding
the function of the protein. For lack of better terms,
structural information is usually classified as one of
secondary, tertiary, and quaternary structure. A
viable general solution to such predictions remains
The idealized evolution of a gene lines is shown from a common
an open problem. As of now, most efforts have been
ancestor in an ancestral population, descending to three populations
directed towards heuristics that work most of the labeled A, B, and C. There are two speciation events, each occurring at
time. the junctions shown as an upside down Y. There are also two
gene-duplication events, depicted by a horizontal bar.
One of the key ideas in bioinformatics is the notion
of homology. In the genomic branch of bioinformatics, homology is used to predict the function of a gene: if the
sequence of gene A, whose function is known, is homologous to the sequence of gene B, whose function is unknown,
one could infer that B may share A's function. In the structural branch of bioinformatics, homology is used to
determine which parts of a protein are important in structure formation and interaction with other proteins. In a
technique called homology modeling, this information is used to predict the structure of a protein once the structure
of a homologous protein is known. This currently remains the only way to predict protein structures reliably.

One example of this is the similar protein homology between hemoglobin in humans and the hemoglobin in legumes
(leghemoglobin). Both serve the same purpose of transporting oxygen in the organism. Though both of these
proteins have completely different amino acid sequences, their protein structures are virtually identical, which
reflects their near identical purposes.
Bioinformatics 19

Molecular Interaction
Efficient software is available today for studying interactions among proteins, ligands, and peptides. Types of
interactions most often encountered in the field include proteinligand (including drug), proteinprotein and
proteinpeptide.
Molecular dynamic simulation of movement of atoms about rotatable bonds is the fundamental principle behind
computational algorithms, termed docking algorithms for studying molecular interactions.

Docking algorithms
In the last two decades, tens of thousands of protein three-dimensional structures have been determined by X-ray
crystallography and protein nuclear magnetic resonance spectroscopy (protein NMR). One central question for the
biological scientist is whether it is practical to predict possible proteinprotein interactions only based on these 3D
shapes, without doing proteinprotein interaction experiments. A variety of methods have been developed to tackle
the proteinprotein docking problem, though it seems that there is still much work to be done in this field.

Software and tools

Software tools for bioinformatics range from simple command-line tools to more complex graphical programs and
standalone web-services available from various bioinformatics companies or public institutions.

Open source bioinformatics software

Many free and open-source bioinformatics software tools have existed since the 1980s. The combination of a
continued need for new algorithms for the analysis of emerging types of biological readouts, the potential for
innovative in silico experiments, and freely available open code bases have helped to create opportunities for all
research groups to contribute to both bioinformatics and the range of open-source software available, regardless of
their funding arrangements. In order to maintain this tradition and create further opportunities, the non-profit Open
Bioinformatics Foundation have supported the annual Bioinformatics Open Source Conference (BOSC) since 2000.

Web services in bioinformatics

SOAP and REST-based interfaces have been developed for a wide variety of bioinformatics applications, allowing
an application running on one computer in one part of the world to use algorithms, data, and computing resources on
servers in other parts of the world. The main advantages derive from the fact that end users do not have to deal with
software and database maintenance overheads.
Basic bioinformatics services are classified by the European Bioinformatics Institute (EBI) into numerous categories,
including ontologies, structures, gene expression, proteins, etc. The availability of these service-oriented
bioinformatics resources demonstrate the applicability of web-based bioinformatics solutions, and range from a
collection of standalone tools with a common data format under a single, standalone, or web-based interface, to
integrative, distributed, and extensible bioinformatics workflow management systems.
Bioinformatics 20

Further reading
Jones, Neil C.; Pevzner, Pavel A. (2004). An Introduction to Bioinformatics Algorithms [1]. MIT Press. pp.435.
ISBN [2]0262101068.
Lesk, Arthur (2008). Introduction to Bioinformatics [2] (3rd ed.). OUP Oxford. pp.474. ISBN [2]0199208042.
Xiong, Jin (2006). Essential Bioinformatics [3]. Cambridge University Press. pp.339. ISBN [2]113945062X.

External links
The Bioinformatics Organization [4]
Bioinformatics Without Borders [5]
Open Bioinformatics Foundation [6]

Notes
Some elements of this article are reused from the Wikipedia article [7].

References
[1] http:/ / books. google. com/ books?id=p_qzpkNVcUwC
[2] http:/ / books. google. com/ books?id=et5qQgAACAAJ
[3] http:/ / books. google. com/ books?id=AFsu7_goA8kC
[4] http:/ / www. bioinformatics. org/
[5] http:/ / www. embnet. org/
[6] http:/ / www. open-bio. org/
[7] http:/ / en. wikipedia. org/ wiki/ Bioinformatics

Cancer informatics
Cancer informatics is a
multidisciplinary field of science that
"deals with the resources, devices, and
methods required to optimize the
acquisition, storage, retrieval, and use
of information in cancer" research and
treatment. Like many other fields of
science, researchers in cancer biology
have seen a dramatic increase in the
amount of clinical and research data, in
particular with genomic and molecular
cancer data. While this data can benefit
researchers' understanding of cancer
behavior and development of better
therapies, new and improved data
management and analysis tools are needed. Cancer informatics attempts to provide those tools "that interconnect
research, clinical activities, and data in an organized and efficient manner, with as broad a database as possible." For
many, the coupling of cancer informatics and other bioinformatics tools with computational modeling and statistical
analysis will accelerate the goal of making cancer a more treatable if not curable disease.
Cancer informatics 21

Application
Cancer informatics can help tackle problems and tasks such as the following:
the development of computational diagnosis, prognosis, and predictive models
the development of standards for the entry, annotation, and sharing of clinical cancer data
the management and distribution of annotated molecular data for further research
the analysis of an individual tumor to determine its molecular phenotype
the development of a treatment plan based on a tumor's molecular phenotype
the tracking of the aberrations that drive a particular cancer's growth

Informatics

In the United States

In the U.S., the field of cancer informatics became much more noticeable with the late 1990s push by the National
Cancer Institute's (NCI's) director Richard D. Klausner to create "a Cancer Informatics Infrastructure (CII) to enable
the cancer research enterprise and to link it to the delivery of cancer care." Klausner saw clinical trials as one of the
key components of cancer research. Given their value to researchers, he recognized clinical trials would require
improved efficiency and openness as well as a new way of openly linking interested parties to the associated trial
data via an information management system. Such a system would need to not only manage clinical trial data but
also provide tools to turn such data into meaningful information.
In the spring of 2004, the NCI began funding the caBIG initiative, which sought to connect U.S. biomedical cancer
researchers using technology known as grid computing. The program, led by the Center for Bioinformatics and
Information Technology (CBIIT), began with a three-year pilot phase. The pilot phase concluded in March 2007, and
56 NCI-designated cancer centers started a trial. The project was furthered still with the development of software and
standards to support project goals. By 2011, the NCI concluded the original goals of the caBIG initiative were
worthy of pursuing, but the program had gotten bloated and off-course. This led to the April 2012 creation of a new
National Cancer Informatics Program (NCIP) that would act as the spiritual successor of caBIG, integrating some of
its informatics programs and ceasing development on others. As of January 2015[1] the NCIP was still being
enacted, funding and developing projects related to cancer genomics data management, creating a software sharing
hub, and releasing code under the open-source model.

In other parts of the world

In 2008, Greek bioinformatician Manolis Tsiknakis discussed the state of cancer informatics in Europe at the 8th
IEEE International Conference on BioInformatics and BioEngineering. He noted developments such as the
Advancing Clinico Genomic Trials on Cancer (ACGT) program, which was originally envisaged as "a unified
technological infrastructure which will facilitate the seamless and secure access and analysis of multi-level clinical
and genomic data enriched with high-performing knowledge discovery operations and services in support of
multi-centric, post-genomic clinical trials." (The ACGT program was eventually halted at the end of July 2010.)
Tsiknakis also referenced the development of the multi-disciplinary myGrid project in the United Kingdom, a funded
effort to help others with the challenges of eScience until at least 2016.
The United States' National Cancer Institute has also played a role in broadening cancer informatics beyond the U.S.
Through its Request for Proposals for Pilot Collaborations with Low- and Mid-Income Countries (LMICs) program,
the NCI has funded the development of cancer informatics infrastructure in countries like El Salvador and Honduras.
Cancer informatics 22

Cancer informatics projects, organizations, and events

Examples of cancer informatics projects, organizations, and events include:
Cancer Genome Atlas [2]: an NCI-funded initiative "to generate comprehensive, multi-dimensional maps of the
key genomic changes in major types and subtypes of cancer"
Cancer Informatics for Cancer Centers [3] (CI4CC): a non-profit "intended to provide a focused national forum for
engagement of senior cancer informatics leaders, primarily aimed at academic cancer centers anywhere in the
world, but with a special emphasis on all 70 NCI-funded cancer centers"
Cancer Informatics Summit [4]: a 2015 conference on cancer informatics
CancerLinQ [5]: driven by the American Society of Clinical Oncology, this program aims to assemble "vast
amounts of usable, searchable, real-world cancer information into a powerful database"
myGrid [6]: a U.K. initiative to develop informatics software for scientists, including cancer researchers
National Cancer Informatics Program [7]: an NCI initiative to expand on the caBIG and other prior projects to
develop cancer informatics tools and infrastructure

External links
Cancer Informatics [8] journal
National Cancer Informatics Program [9] at GitHub

References
[1] http:/ / limswiki. org/ index. php?title=Cancer_informatics& action=edit
[2] http:/ / cancergenome. nih. gov/ abouttcga/ overview
[3] http:/ / www. ci4cc. org/ about
[4] http:/ / www. cancerinformaticssummit. com/
[5] http:/ / cancerlinq. org/
[6] http:/ / www. mygrid. org. uk/ about-us/
[7] https:/ / cbiit. nci. nih. gov/ ncip
[8] http:/ / www. la-press. com/ journal-cancer-informatics-j10
[9] https:/ / github. com/ ncip
Chemical informatics 23

Chemical informatics
Chemical informatics (more
commonly known as
chemoinformatics and
cheminformatics) is the use of
computer and informational techniques
applied to a range of problems in the
field of chemistry. While the field has
roughly been around around since the
1990s, the rise in high-throughput
screening (a scientific experimentation
method primarily used in drug
discovery) and combinatorial
chemistry (a method of synthesizing a
large number of compounds in a single
process), as well as increases in The Jmol open-source Java viewer for chemical 3D structures is an example of a software
application that may be used in the field of chemical informatics.
computing power and data storage
sizes, have increased interest in the
field in the twenty-first century.

Outside of pharmaceutical research, other applications of chemical informatics include the area of topology,
chemical graph theory, and mining the chemical space. It can also be applied to data analysis for the paper, pulp, and
dye industries.

History
The 1960s saw the introduction of databases for the storage and retrieval of chemical structures, as well as
three-dimensional molecular modeling methods, laying the groundwork for future generations to improve
computational methods of chemical and molecular analysis.
The term "chemoinformatics" was defined by F.K. Brown in 1998 as such:
Chemoinformatics is the mixing of those information resources to transform data into information and
information into knowledge for the intended purpose of making better decisions faster in the area of
drug lead identification and optimization.
Since then, both the "chem" and "chemo" spellings have been used. European academia settled on the term
"chemoinformatics" for its 2006 Obernai research and teaching workshop. Other entities like the Journal of
Cheminformatics and Slovak company Molinspiration have trended towards "cheminformatics."
Chemical informatics 24

Application

Storage and retrieval

The primary application of chemical informatics is in the storage and retrieval of both structured and unstructured
information relating to chemical structures, molecular models and other chemical data. Efficiently querying and
retrieving that stored information extends into other realms of computer science like data mining and machine
learning. Other forms of data querying include graph, molecule, sequence, and tree mining.

Representation
The in silico representation of chemical structures uses specialized formats such as the XML-based Chemical
Markup Language or Simplified Molecular-Input Line-Entry System (SMILES) specifications. These representations
are often used for storage in large chemical databases. While some formats are suited for visual representations in
two or three dimensions, others are more suited for studying physical interactions, modeling, and docking studies.

Virtual libraries
Stored chemical data can pertain to both real and virtual molecules. Virtual libraries of such molecules and
compounds may be generated in various ways to explore chemical space and hypothesize novel compounds with
desired properties. The Fragment Optimized Growth (FOG) algorithm, for example, was developed to "grow" novel
classes of compounds like drugs, natural products, and diversity-oriented synthetic products from a training database
of existing compounds.

Virtual screening
In contrast to high-throughput screening, virtual screening involves computationally screening in silico libraries of
compounds, by means of various methods such as docking, to identify members likely to possess desired properties
such as biological activity against a given target. In some cases, combinatorial chemistry is used in the development
of the library to increase the efficiency in mining the chemical space. More commonly, a diverse library of small
molecules or natural products is screened.

Quantitative structure-activity relationship (QSAR)

This is the calculation of quantitative structure-activity relationship and quantitative structure property relationship
values, used to predict the activity of compounds from their structures. In this context there is also a strong
relationship to chemometrics, the science of extracting information from chemical systems by data-driven means.
Chemical expert systems are also relevant since they represent parts of chemical knowledge as an in silico
representation.

External links
Cambridge Healthtech Institute Cheminformatics/ Chemoinformatics Glossary & Taxonomy [1]
Indiana Cheminformatics Education Portal [2]
The Blue Obelisk Project [3]
The Chemical Structure Association Trust [4]
The eCheminfo Network and Community of Practice [5]
The UK-QSAR and ChemoInformatics Group [6]
Chemical informatics 25

Notes
This article reuses portions of content from the Wikipedia article [7].

References
[1] http:/ / www. genomicglossaries. com/ content/ chemoinformatics_gloss. asp
[2] http:/ / icep. wikispaces. com/
[3] http:/ / www. blueobelisk. org/
[4] http:/ / www. csa-trust. org
[5] http:/ / www. echeminfo. com/
[6] http:/ / www. ukqsar. org
[7] http:/ / en. wikipedia. org/ wiki/ Cheminformatics

Environmental informatics
Environmental informatics (EI) is a
developing field of science that applies
information processing, management,
and sharing strategies to the
interdisciplinary field of environmental
science. Applications include the
integration of information and
knowledge, the application of
computational intelligence to
environmental data, and the
identification of the environmental Publicly available data sets and informatics tools like open-source SAGA GIS
[1]
enable
impacts of information technology. EI the creation of environmental models and images such as this.
helps scientists define information
processing requirements, analyze real-world problems, and solve those problems using informatics methodologies
and tools.

As EI has continued to evolve, several other definitions have been offered over the years:
"an emerging field centering around the development of standards and protocols, both technical and institutional,
for sharing and integrating environmental data and information." - Biosphere Data Project, University of
California - Berkeley, 2004
the application of "[r]esearch and system development focusing on the environmental sciences relating to the
creation, collection, storage, processing, modelling, interpretation, display and dissemination of data and
information." - Natural Environment Research Council, 2014

History
Environmental informatics emerged roughly around the late 1980s in Central Europe. For example, in 1986
Germany's Gesellschaft fr Informatik (Society for Computer Science) created the technical committee Informatik
im Umweltschutz (Computer Science in Environmental Protection) dedicated to "the whole spectrum of subjects
related to informatics in environmental protection." The group is still active as of 2014, set to host it's 28th
International Conference on Informatics for Environmental Protection. Since Informatik im Umweltschutz's
inception, other groups there and in other regions of the world were created, including The International
Environmetrics Society (TIES, founded in 1989) and the International Environmental Modelling and Software
Environmental informatics 26

Society (iEMSs, founded in 2000), as well as conferences like the International Symposium on Environmental
Software Systems (ISESS, founded in 1995).

Application
Environmental informatics can help tackle problems and tasks such as the following:
the acquisition and application of remote sensing data from optical, thermal infrared, and microwave instruments
targeting the atmosphere, vegetation, and the ocean
the estimation of aerosol load in the atmosphere
the gauging of influence of trace gases, aerosol, and clouds on the weather and climate
the analysis of geographical features for urban and regional development
the modeling and assessment of ecological environments
the development and optimization of mathematical algorithms for environmental modeling

Ecoinformatics
Closely related to EI is the concept of ecological informatics or "ecoinformatics," which essentially takes
environmental informatics and adds the consideration of anthropogenic activity trends. Ecoinformatics aims to
facilitate environmental research and management by developing ways to access, manage, and integrate databases of
environmental information and develop new algorithms enabling different environmental datasets to be combined to
test ecological hypotheses.

Further reading
Recknagel, Friedrich; Jrgensen, Sven Erik (ed.); Chon, T. S. (ed.) (2009). "Chapter 3: Ecological Informatics:
Current Scope and Feature Areas" [2]. Handbook of Ecological Modelling and Informatics. WIT Press. pp.4147.
ISBN [2]9781845642075.
Voigt, Kristina (July 2008). "Environmental Informatics, Environmetrics, Chemoinformatics, Chemometrics:
Integration or Separation!?" [3] (PDF). International Congress on Environmental Modelling and Software.
Proceedings of the iEMSs Fourth Biennial Meeting. 3: 15941601. ISBN [2]9788476530740.

External links
Data Observation Network for Earth [4] (DataONE)
ecoinformatics.org - Online Resource for Managing Ecological Data and Information [5]
Ecological Data Wiki [6]
Ecological Informatics: An International Journal on Ecoinformatics and Computational Ecology [7]
Frontiers in Environmental Science - Environmental Informatics [8]
Informatik fr Umweltschutz, Nachhaltige Entwicklung und Risikomanagement [9] (formerly Informatik im
Umweltschutz)
International Environmental Modelling and Software Society [10] (iEMSs)
International Society for Environmental Information Sciences [11] (ISEIS)
Journal of Environmental Informatics [12]
The International Environmetrics Society [13] (TIES)
Environmental informatics 27

Notes
This article reuses a couple of elements from the Wikipedia article [14].

References
[1] http:/ / saga-gis. org/ en/ index. html
[2] http:/ / books. google. com/ books?id=XzEKlNhnUHUC& pg=PA41
[3] http:/ / www. iemss. org/ iemss2008/ uploads/ Main/ S18-01-Voigt_et_al-IEMSS2008. pdf
[4] http:/ / www. dataone. org
[5] http:/ / www. ecoinformatics. org
[6] http:/ / www. ecologicaldata. org/
[7] http:/ / www. journals. elsevier. com/ ecological-informatics/
[8] http:/ / www. frontiersin. org/ Environmental_Informatics
[9] http:/ / enviroinfo. eu/
[10] http:/ / www. iemss. org/
[11] http:/ / www. iseis. org/
[12] http:/ / www. iseis. org/ jei/
[13] http:/ / www. environmetrics. org/
[14] http:/ / en. wikipedia. org/ wiki/ Environmental_informatics

Evolutionary informatics
Evolutionary informatics is a sub-branch of
informatics that addresses the algorithmic and
technological tools (like information and analytical
systems) needed to better manage data from research
in ecology and evolutionary biology and answer
evolutionary questions.

As in bioinformatics and genomics, scientists

studying biological evolution have gathered an
increasingly large volume of information, resulting
in information management problems. Additionally,
as bioinformatics and genomics are pertinent to the
study of evolution, utilization of information from
those areas is of concern in evolutionary informatics.

History
Evolutionary informatics has evolved out of a wide
variety of scientific, mathematical, and
computational endeavors, including evolutionary
biology, evolutionary computation, algorithmic and
evolutionary algorithmic research, and software
development.
In 2006, the National Science Foundation-sponsored Phylogenomics and computational biology play important roles in
National Evolutionary Synthesis Center (NESCent) evolutionary informatics, changing the way we view the Tree of Life.
Evolutionary informatics 28

promoted the NESCent Evolutionary Informatics Working Group to "develop community cohesion on issues of
standards and interoperability" of the infrastructure and tools used for "integrating evolutionary methodology into
biological data analysis." In subsequent years, NESCent became involved in creating the Hackathons,
Interoperability, Phylogenies (HIP) working group and advancing several databases, libraries, and ontologies in the
field of evolutionary biology.
In 2007, Professor Robert Marks included the term "evolutionary informatics" in the title and content of his Baylor
University-hosted website Evolutionary Informatics Laboratory (EIL). The university's administration subsequently
took down the website for having "unapproved research," which reportedly included unpublished scholarly papers
coauthored by Marks and intelligent design advocate William A. Dembski. Marks moved the content removed from
Baylor servers to a new domain. Its front page stated the following concerning evolutionary informatics:
Evolutionary informatics merges theories of evolution and information, thereby wedding the natural,
engineering, and mathematical sciences. Evolutionary informatics studies how evolving systems
incorporate, transform, and export information. The Evolutionary Informatics Laboratory explores the
conceptual foundations, mathematical development, and empirical application of evolutionary
informatics. The principal theme of the labs research is teasing apart the respective roles of internally
generated and externally applied information in the performance of evolutionary systems.
In June 2010, the first ever Informatics for Phylogenetics, Evolution, and Biodiversity (iEvoBio) Conference took
place in Portland, Oregon, with the goal of "both to catalyse the development of new tools, and to increase awareness
of the possibilities offered by existing technologies." The sixth annual conference is scheduled for May 2015.

Application
Evolutionary informatics can help tackle problems and tasks such as the following:
Connecting genomics data with scalable taxonomic concepts and data to reduce "the growing number of lineages
that lack formal taxonomic names"
Leveraging legacy biodiversity data by digitizing it, semantically enhancing it, and making it more portable
Building "sustainable digital community repositories that provide access to rich data and metadata" in the field of
evolutionary biology
Building "a semantic web for evolutionary biology" that uses data querying, mining, and integration tools
Developing algorithms to better model evolutionary changes

Informatics
The U.S. National Science Foundation-funded NESCent has been one of the key groups responsible for advancing
the application of informatics to evolutionary biology problems in the twenty-first century. Started in 2004, NESCent
has furthered several informatics goals in the field of evolutionary informatics by:
contributing to the Generic Model Organism Database (GMOD) project "to further develop the data model for
evolutionary datatypes (named organisms, georeferenced collections, genetic and phenotypic variability, and
phylogenies), to develop web applications for accessing these types of data, and to provide user support for
adoption of the GMOD platform for evolutionary model organisms."
promoting and contributing to several projects (Phenoscape, Phenex, OBO Foundry) that work with phenotype
ontologies and their application to evolutionary morphologies.
promoting the integration of geoinformatics with evolutionary informatics so researcher may better "integrate
population genetic and phylogenetic models of multiple taxa with data describing present and past environments
and climate"; one such success has been GeoPhyloBuilder.
integrating the wide variety of existing tools to interoperate with each other through hack-a-thons and cooperation
with open-source developers.
Evolutionary informatics 29

"working to establish a digital repository for published data" in the biosciences.

Application of algorithms to evolutionary biology

The notion that information processing is essential to the evolutionary process predates the entry of the term
"informatics" into the English language around 1967. Investigators were arguing as early as the 1940s that certain
principles of information processing apply to both living and engineered systems, with much of their thinking
encapsulated in Norbert Wiener's Cybernetics: or Control and Communication in the Animal and the Machine.
Wiener regarded evolution as "phylogenetic learning," or accrual of information in the genome.
Modern work has focused on evolution as more of an optimization of fitness functions, addressing the role of
information in optimization. Work by researchers David Wolpert and William G. Macready in the mid-1990s
established that evolutionary algorithms have average performance no better than that of random search. They
argued that superior performance could be achieved only if algorithms incorporate prior knowledge of problems, and
provided an information-geometric analysis of how algorithms and problems are matched (and mismatched).
After reviewing Wolper and Macready's work on the "no free lunch" theorems, researcher Thomas M. English
argued there was no free lunch due to an underlying "conservation of information," and that the duo's work "mistakes
selection bias for prior information of the objective function." In 2000, English turned to Kolmogorov complexity as
a measure of information in instances of fitness functions and optimization algorithms. He observed that almost all
problems exhibit a high degree of Kolmogorov randomness, and thus those problems are easy for almost all
optimization algorithms. English later gave a new perspective on conservation by way of characterizing approximate
satisfaction of a necessary and sufficient condition for "no free lunch."
Wolpert and Macready went on to prove the existence of coevolutionary "free lunches" in 2005. This may be
interpreted as the discovery of a problem class for which some coevolutionary algorithms in biology are generally
better informed than others of how to solve problems.

Further reading
Parr, Cynthia S.; Guralnick, Robert; Cellinese, Nico; Page, Roderic D.M (February 2012). "Evolutionary
informatics: Unifying knowledge about the diversity of life" [1]. Trends in Ecology and Evolution 27 (2): 94103.
doi [2]:10.1016/j.tree.2011.11.001 [3]. PMID [4]22154516 [1].

External links
iEvoBio Conference [5]
NESCent [6]
Evolutionary Informatics Lab [7]
Evolutionary informatics 30

Notes
This article reuses some content from the Wikipedia article [8].

References
[1] http:/ / www. ncbi. nlm. nih. gov/ pubmed/ 22154516
[2] http:/ / en. wikipedia. org/ wiki/ Digital_object_identifier
[3] http:/ / dx. doi. org/ 10. 1016%2Fj. tree. 2011. 11. 001
[4] http:/ / en. wikipedia. org/ wiki/ PubMed_Identifier
[5] https:/ / ievobio. wordpress. com/
[6] http:/ / www. nescent. org/
[7] http:/ / www. evoinfo. org/ index/
[8] http:/ / en. wikipedia. org/ wiki/ Evolutionary_informatics

Geoinformatics
Geoinformatics is a multidisciplinary
field of science that uses technologies
supporting the processes of acquiring,
analyzing, and visualizing geospatial
data.
The definition of the term
"geoinformatics" varies greatly,
however. For example, author G.
Randy Keller, focusing on the internals
of our planet, explained geoinformatics
as the use of "data, software tools, and
computational infrastructure ... to
facilitate studies of the structure,
dynamics, and evolution of the solid
Earth through time, as well as the
processes that act upon it and within it Geological scientists use geoinformatics tools to create 3D maps of not only Earth's
from the near surface to the core." surface but also, as in the case of astrogeology, the surface of other planets like Mars.

Other definitions of geoinformatics

dutifully extend its scope to the surface of the planet, causing more confusion as terms like "geomatics,"
"geographical information system," and "computational geography" are brought to the discussion from different
regions around the world and are often used synonymously. Senior lecturer Ji ma of the University of West
Bohemia in Pilsen attempts to compare "geomatics" and "geoinformatics" using ISO standards:

"According to ISO Standard 19122 'geomatics is a discipline concerned with the collection, distribution,
storage, analysis, processing, presentation of geographic data or geographic information.' Its range is
perfectly described by activities of the Geomatics Canada: establishing and maintainace [sic] of national
spatial reference system, preparing, publishing and distributing of state topographical maps, aeronautical
charts, aerial photographs and gazetteers, surveys on state boundaries, property surveys on federal lands,
maintainance [sic] of national bases of geographic data for the development of geographical information
systems.
There is no definition of geoinformatics in ISO Standards. One of the best was published by Dietmar
Grnreich, president of the Federal Agency for Cartography and Geodesy in Frankfurt (Main):
Geoinformatics 31

'geoinformatics is a discipline concerned with theory of geospatial data modeling, their storage,
management and processing as well as with development of geographical information systems and
necessary information and communication technology.'"

Application
Geoinformatics can help tackle problems and tasks such as the following:
the modeling and use of seismic data
the construction and use of other geologically realistic 3-D models
the production of high-quality paleogeographic maps
the production of astrogeological 3D maps
the measurement of Earth's gravity field
the mitigation of hazards in volcanically active areas
the planning and management of land use
the reconstruction of architecture and archeological sites
the creation of commercial maritime routes
the management of natural resources

Informatics
Scientists practicing in the earth sciences increasingly rely on digital spatial data acquired and visualized from
remotely sensed images analyzed by geographical information systems (GIS). Other informatics tools include
geospatial analysis and modeling software, geospatial databases, and wired and wireless networking technologies.
As these types of systems and tools have become more readily available, a larger global initiative to use them for
greater data integration and sharing has emerged. GEON, for example, is an open collaborative project for creating
infrastructure for collecting 3- and 4D geospatial data. OneGeology is another global informatics initiative
attempting to compile digital geological map data for all to use.

Further reading
Sinha, A. Krishna, et al. (December 2010). "Geoinformatics: Transforming data to knowledge for geosciences"
[1]
. GSA Today 20 (12): 410. doi [2]:10.1130/GSATG85A.1 [2].

External links
GEON [3]
International Cartographic Association [4] (ICA)
International Society for Photogrammetry and Remote Sensing [5] (ISPRS)
International Union of Geodesy and Geophysics [6] (IUGG)
OneGeology [7]
Open Geospatial Consortium [8] (OGC)
Geoinformatics 32

Notes
This article reuses a few elements from the Wikipedia article [9].

References
[1] http:/ / www. geosociety. org/ gsatoday/ archive/ 20/ 12/ article/ i1052-5173-20-12-4. htm
[2] http:/ / dx. doi. org/ 10. 1130%2FGSATG85A. 1
[3] http:/ / www. geongrid. org/
[4] http:/ / www. icaci. org/
[5] http:/ / www. isprs. org/
[6] http:/ / www. iugg. org/
[7] http:/ / www. onegeology. org/
[8] http:/ / www. opengeospatial. org/
[9] http:/ / en. wikipedia. org/ wiki/ Geoinformatics

Health informatics
Health informatics (also called health
care informatics, healthcare
informatics, medical informatics,
nursing informatics, clinical
informatics, or biomedical
informatics) is a discipline at the
intersection of information science,
computer science, and health care. It
deals with the resources, devices, and
methods required to optimize the
"collection, storage, retrieval, [and]
communication ... of health-related
data, information, and knowledge."
Health informatics is applied to the
areas of nursing, clinical care,
dentistry, pharmacy, public health,
occupational therapy, and biomedical Health informatics helps manage, analyze, and integrate patient data from physician to
specialist and beyond.
research. Health informatics resources
include not only computers but also
clinical guidelines, formal medical terminologies, and information and communication systems.

Early names for health informatics included medical information data processing, medical information science,
medical informatics, medical computer science, and medical computing.

History
Worldwide use of technology in medicine began in the early 1950s with the rise of computers. In 1949, Gustav
Wager established the first professional organization for informatics in Germany. The prehistory, history, and future
of medical information and health information technology are discussed in reference. Specialized university
departments and Informatics training programs began during the 1960s in France, Germany, Belgium and The
Netherlands. Medical informatics research units began to appear during the 1970s in Poland and in the U.S., with
medical informatics conferences springing up as early as 1974. Since then the development of high-quality health
Health informatics 33

informatics research, education, and infrastructure has been the goal of the U.S. and the European Union.
By the mid-2000s, work in the U.K. by the voluntary registration body the UK Council of Health Informatics
Professions led to the creation of eight key constituencies within the domain of health informatics: information and
communication technologies; health records; information management; knowledge management; health informatics
service and project management; clinical informatics; education, training, and development; and research. Those
constituencies already based on U.K. National Health Service standards (NHS) later found their way into the
NHS' Health Informatics Career Framework in a slightly modified format. As of 2013[1] tens of datasets,
publications, guidelines, specifications, meetings, conferences, and organizations around the world continue to shape
what health informatics is today.

Health informatics in North America

Argentina
Since 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has
sought to develop health informatics within the region, including Argentina's Asociacin Argentina de Informtica
Mdica (AAIM).
Since 1997, the not-for-profit Buenos Aires Biomedical Informatics Group has represented the interests of a broad
range of clinical and non-clinical professionals working within the health informatics sphere. The group strives to
promote informatics technology and related content within the research and health administration spheres, especially
those relating to the biomedical field.

Brazil
"In 1968 the Pan American Health Organization set up the Regional Library of Medicine and Health Sciences
(BIREME) in the Paulista Medical School in So Paulo under an agreement with the Government of Brazil." The
library also made possible access to the MEDLINE and MEDLARS systems, and it would eventually go on to
become the "hub of the Latin American network of biomedical and health information."
In 1986 the Brazilian Society of Health Informatics (Sociedade Brasileira de Informtica em Sade) was founded to
better expand the use of informatics technology within the country. The same year saw the first Brazilian Congress
of Health Informatics held, and the first Brazilian Journal of Health Informatics was published.
Since 1996, the International Medical Informatics Association's Latin America and the Caribbean regional group has
sought to develop health informatics within the region, including Brazil's Sociedade Brasileira de Informtica em
Sade (SBIS).

Canada
Health Informatics projects in Canada are implemented provincially, with different provinces creating different
systems. A national, federally-funded, not-for-profit organization called Canada Health Infoway was created in 2001
to foster the development and adoption of electronic health records across Canada. As of July 2013[1] there were
380 health informatics projects under way in Canadian hospitals, health-care facilities, pharmacies, and laboratories,
with an investment value of $2.1 billion since its inception.
Provincial and territorial programs include the following:
eHealth Ontario was created as an Ontario provincial government agency in September 2008. It has been
plagued by delays, and its CEO was fired over a multi-million dollar contract scandal in 2009.
Alberta Netcare Portal was created in 2006 by the Government of Alberta. The Netcare portal is used daily by
thousands of clinicians. It provides access to demographic data, prescribed/dispensed drugs, known
allergies/intolerances, immunizations, laboratory test results, diagnostic imaging reports, the diabetes registry and
other medical reports. Netcare interface capabilities are being included in electronic medical record products
Health informatics 34

which are being funded by the provincial government.

United States
Even though the idea of using computers in medicine sprouted as technology advanced in the early twentieth
century, it was not until the 1950s that informatics made a realistic impact in the United States. Robert Ledley led the
charge in the 1950s with his early use of medical computation in his dental projects at the United States National
Bureau of Standards.
By the mid-1950s expert systems such as MYCIN and Internist-I were developed, and the National Library of
Medicine started using even the even more advanced MEDLINE and MEDLARS systems by 1965. Around this
same time a flurry of activity occurred. At the University of Utah, Dr. Homer R. Warner, one of the fathers of
medical informatics, was already offering graduate-level classes in medical computer applications. Meanwhile Neil
Pappalardo, Curtis Marble, and Robert Greenes were developing the Massachusetts General Hospital Utility
Multi-Programming System (MUMPS) in Octo Barnett's Laboratory of Computer Science at Massachusetts General
Hospital in Boston. Yet due to its advanced nature, fragmented use across multiple entities, and inherent difficulty in
extracting and analyzing data from the database, development of healthcare and laboratory systems on MUMPS was
sporadic at best.
By the 1980s, however, the advent of Structured Query Language (SQL), relational database management systems
(RDBMS), and Health Level 7 (HL7) allowed software developers to expand the functionality and interoperability of
health informatics systems, including the application of business analytics and business intelligence techniques to
clinical data. As of 2013[1] web-based and database-centric Internet applications of laboratory informatics software
have further changed the way researchers and technicians interact with data, with web-driven data formatting
technologies like Extensible Markup Language (XML) making interoperability of health and laboratory informatics
software a much-needed reality. SaaS and cloud computing technologies have further changed how informatics
systems are implemented in the U.S and worldwide, while at the same time raising new questions about security and
stability.

Health informatics in Europe

The European Union's Member States are committed to sharing their best practices and experiences to create a
European eHealth Area, thereby improving access to and quality health care at the same time as stimulating growth
in a promising new industrial sector. The associated European eHealth programs plays a fundamental role in the
European Union's strategy. Work on this initiative involves a collaborative approach among several parts of the
Commission services. Additionally, the not-for-profit European Institute for Health Records or EuroRec has
promoted the use of high quality electronic health record systems in the European Union since its foundation in late
2002.
epSOS (European Patients - Smart Open Services) represents another key European initiative to "build and evaluate
a service infrastructure that demonstrates cross-border interoperability between electronic health record systems in
Europe." Co-funded by the European Commission Competitiveness and Innovation Programme since 2008, the
initiative (scheduled to finish on December 31, 2013) was devised with the vision of giving patients in Europe the
opportunity to use cross-border electronic medical record services for healthcare-related activities in participating
epSOS pilot countries.
Health informatics 35

In the United Kingdom

The U.K. health informatics community has long played a key role in international activity, joining Technical
Committee Four (TC 4) of the International Federation of Information Processing in 1968, which eventually became
the International Medical Informatics Association (IMIA) in 1979. In 1978, the Medical Specialist Group of the
British Computer Society organized the first European Federation for Medical Informatics (EFMI) Medical
Informatics Europe (MIE) conference in Cambridge.
In 2002, the idea of a profession of health informatics across the U.K. was first implemented as the U.K. Council for
Health Informatics Professions (UKCHIP), which has a formal Code of Professional Conduct, standards for
expressing competences which are used for entry, confirmation of fitness to practice, re-grading and personal
development. Consistent standards express competences of health informatics professionals in both domain-specific
and generic informatics professional areas. The consistency is intended to apply in operational care delivery
organizations, academia, and the commercial service and solution providers.
The broad history of health informatics in the U.K. has been captured in the 2008 book U.K. Health Computing :
Recollections and Reflections by Glyn M. Hayes and Denise E. Barnett. The book describes the early development
of health informatics in the country as "unorganized and idiosyncratic."

England
In 2002 the National Health Service (NHS) in England contracted several vendors for a national health informatics
system called the National Programme for IT or "NPfIT." By 2010, however, the project drastically behind schedule,
forcing a wide consultation to be launched as part of a wider "Liberating the NHS" plan. "Following three reports on
the National Programme by both the National Audit Office and this Committee, and a review by the Major Projects
Authority, the Government announced in September 2011 that it would dismantle the National Programme but keep
the component parts in place with separate management and accountability structures." The program was officially
dismantled in September 2013, officially dubbed "one of the worst and most expensive contracting fiascos in the
history of the public sector."

Scotland
In 1984, Scotland saw the implementation of the General Practice Administration System (GPASS), developed and
controlled by NHS Scotland. It was provided free to all general practitioners in Scotland. However, an agreement
was reached in 2008 to shut down the electronic system due to "a series of problems and critical reports." The system
was formally shut down in August 2012, with all practices having moved to new systems called EMIS and INPS.

Health informatics in Asia and Oceania

In Asia, Australia, and New Zealand, the regional group called the Asia Pacific Association for Medical Informatics
(APAMI) was established in 1993 and now consists of more than 15 member regions in the Asia Pacific Region.

Australia
Founded in 2002, the Australasian College of Health Informatics (ACHI) is the professional association for health
informatics in the Asia-Pacific region. It represents the interests of a broad range of clinical and non-clinical
professionals working within the health informatics sphere through a commitment to quality, standards, and ethical
practice. ACHI is a sponsor of the e-Journal for Health Informatics, an indexed and peer-reviewed professional
journal. ACHI has also supported the Australian Health Informatics Education Council (AHIEC) since its founding
in 2009.
Although there are a number of health informatics organizations in Australia, the Health Informatics Society of
Australia (HISA) is regarded as the major umbrella group and is a member of the International Medical Informatics
Association (IMIA). Nursing informaticians were the driving force behind the formation of HISA, which is now a
Health informatics 36

company limited by guarantee of the members. The membership comes from across the informatics spectrum that is
from students to corporate affiliates. HISA has a number of branches (Queensland, New South Wales, Victoria and
Western Australia) as well as special interest groups such as nursing (NIA), pathology, aged and community care,
industry, and medical imaging.

China
In Hong Kong a computerized patient record system called the Clinical Management System (CMS) has been
developed by the Hospital Authority since 1994. This system has been deployed at all the sites of the Authority (40
hospitals and 120 clinics) and is used by all 30,000 clinical staff on a daily basis, with a daily transaction of up to 2
millions. The comprehensive records of 7 million patients are available online in the Electronic Patient Record
(ePR), with data integrated from all sites. Since 2004, radiology image viewing has been added to the ePR, with
radiography images from any HA site being available as part of the ePR.
The Hong Kong Hospital Authority placed particular attention to the governance of clinical systems development,
with input from hundreds of clinicians being incorporated through a structured process. The health informatics
section of the Hong Kong Hospital Authority has close relationship with the information technology department and
clinicians to develop healthcare systems for the organization to support the service to all public hospitals and clinics
in the region.
The Hong Kong Society of Medical Informatics (HKSMI) was established in 1987 to promote the use of information
technology in healthcare. The eHealth Consortium has been formed to bring together clinicians from both the private
and public sectors, medical informatics professionals, and the IT industry to further promote IT in healthcare in
Hong Kong.

New Zealand
Health Informatics is taught at five New Zealand universities. The most mature and established is the Otago
program, which has been offered since the mid-1990s. Health Informatics New Zealand (HINZ) is the national
organization that advocates for health informatics. HINZ organizes a conference every year and also publishes the
online journal Healthcare Informatics Review Online.

Health informatics in the Middle East

Saudi Arabia
The Saudi Association for Health Information (SAHI) was established in 2006 to work under direct supervision of
King Saud University for Health Sciences to practice public activities, develop theoretical and applicable knowledge,
and provide scientific and applicable studies.

Regulation and standards

The international standards on the subject are covered by ICS 35.240.80 in which ISO 27799:2008 is one of the core
components.

In the United States

In 2004 the U.S. Department of Health and Human Services (HHS) formed the Office of the National Coordinator
for Health Information Technology (ONCHIT). The mission of this office is widespread adoption of interoperable
electronic health records (EHRs) in the US within 10 years.
The Certification Commission for Healthcare Information Technology (CCHIT), a private nonprofit group, was
funded in 2005 by the U.S. Department of Health and Human Services to develop a set of standards for electronic
health records (EHR) and supporting networks, and certify vendors who meet them. In July, 2006 CCHIT released
Health informatics 37

its first list of 22 certified ambulatory EHR products, in two different announcements.

Clinical Informatics
While health informatics and clinical informatics are often considered the same, some make a distinction between
the two. The American Medical Informatics Association, for example, states clinical informatics is concerned with
the use of information in health care by clinicians. By extension, clinical informaticians analyze, design, implement,
and evaluate information and communication systems that enhance individual and population health outcomes,
improve patient care, and strengthen the clinician-patient relationship.
Clinical informaticians use their knowledge of patient care combined with their understanding of informatics
concepts, methods, and health informatics tools to:
assess information and knowledge needs of health care professionals and patients.
characterize, evaluate, and refine clinical processes.
develop, implement, and refine clinical decision support systems.
lead or participate in the procurement, customization, development, implementation, management, evaluation,
and continuous improvement of clinical information systems.
Clinicians collaborate with other health care and information technology professionals to develop health informatics
tools which promote patient care that is safe, efficient, effective, timely, patient-centered, and equitable.

Further reading
De Moor, Georges J. E. ; McDonald, Clement J.; van Goor, J. M. Noothoven, ed. (1993). Progress in
Standardization in Health Care Informatics [2]. IOS Press. pp.215. ISBN [2]9051991142.
Hovenga, Evelyn J. S., ed. (2010). Health Informatics: An Overview [3]. IOS Press. ISBN [2]1607500922.
Hoyt, Robert E.; Bailey, Nora; Yoshihashi, Ann, ed. (2012). Health Informatics: Practical Guide For Healthcare
And Information Technology Professionals [4]. Lulu Enterprises Incorporated. pp.492. ISBN [2]1105437558.
Smith, Jack (1999). Health Management Information Systems: A Handbook for Decision Makers [5] (2nd ed.).
McGraw-Hill International. pp.348. ISBN [2]0335205658.

Notes
Some elements of this article are reused from the Wikipedia article [6].

References
[1] http:/ / limswiki. org/ index. php?title=Health_informatics& action=edit
[2] http:/ / books. google. com/ books?id=DHzOJaNaOYkC
[3] http:/ / books. google. com/ books?id=eckD3fSrPagC
[4] http:/ / books. google. com/ books?id=6bqruAAACAAJ
[5] http:/ / books. google. com/ books?id=8YjlAAAAQBAJ
[6] http:/ / en. wikipedia. org/ wiki/ Health_informatics
Hydroinformatics 38

Hydroinformatics
Hydroinformatics is the
multidisciplinary application of
information and decision support
systems to address the equitable and
efficient management and use of water
for many different purposes.
Hydroinformatics draws on and
integrates hydraulics, hydrology,
environmental engineering, and many
other disciplines. It sees application at
all points in the water cycle, from
Global freshwater models like WaterGAP create data representations like this for
atmosphere to ocean, and in artificial
hydroinformaticians.
interventions in that cycle such as
urban drainage and water supply
systems. It provides support for decision making at all levels, from governance and policy through to management
and operations.

Hydroinformatics also recognises the inherently social nature of the problems of water management and of decision
making processes, and it includes mechanisms towards understanding the social processes by which technologies are
brought into use and how they change the water system. Since the resources to obtain and develop technological
solutions affecting water collection, purification, and distribution continue to be concentrated in the hands of the
minority, the need to examine these social processes are particularly acute:
"[T]he role of the hydroinformatician in this process is to create sociotechnical environments in which
the transmutations necessary to provide states of social justice can be catalysed through the creation of
appropriate technologies. These technologies are those that can transform data and technical information
into a form of knowledge and understanding that can be assimilated by the non-technical stakeholders so
that they can contribute meaningfully and responsibly to the decision-making process. Therefore, one of
the aims of hydroinformatics is a completely transparent decision making process involving all
stakeholders in a water infrastructure project along with the relevant professionals directed to
realisations of social justice, which are understood as transcendental states of social being."

History
While the concepts of hydrological modeling and computational hydraulics have been around since at least the late
1950, the term "hydroinformatics" wasn't born from those concepts until the late 1980s. At that time hydrological
numerical modeling, data collection, and data processing were beginning to expand and synchronize: studies of
water flow looked at more variables, recordings and samplings expanded in scope, and networked computer systems
became more powerful. By 1991, professor Michael B. Abbott published Hydroinformatics: Information Technology
and the Aquatic Environment, a seminal work in the field. In September 1994, the first International Conference on
Hydroinformatics was held, followed by the launch of the Journal of Hydroinformatics in 1999. And in 2003 an
experimental graduate-level course on the topic was taught at the University of Illinois. As of 2014[1], entities like
Utah State University, Brigham Young University, Newcastle University, and UNESCO are all offering graduate
and postgraduate courses on the topic of hydroinformatics.
Hydroinformatics 39

Application
Hydroinformatics can help tackle problems and tasks such as the following:
the multidimensional modeling of flow phenomena in specific geometries
the development of better shallow-water flow models
the optimization of damn breaks
the development of flood protection for a city
the development of artificial neural networks for better data analysis
the construction of bridges across bodies of water
the development of environmental models to better manage crop irrigation from year to year
the interpretation and management of the instrumentation and wireless sensor data of automated irrigation
systems

Informatics
Like other fields of informatics, hydroinformaticians have recognized the need for a larger global initiative to use
technology for greater data integration and sharing in the field. International efforts to create databases like those
found at the Global Runoff Data Centre, Global Hydrology Resource Center, and AQUASTAT have furthered that
goal. Freeware like CROPWAT and open-source software like HYPE OSC have further added to the informatics
tools available to hydrologists.

Recommended reading
Abbott, Michael B. (1991). Hydroinformatics: Information Technology and the Aquatic Environment [2]. Avebury
Technical. pp.145. ISBN [2]9781856288323.
Price, Roland K.; Vojinovi, Zoran (2011). "Chapter 3: Hydroinformatics" [3]. Urban Hydroinformatics: Data,
Models, and Decision Support for Integrated Urban Water Management. IWA Publishing. pp.3961. ISBN
[2]
9781843392743.

External links
AQUASTAT [4]
CROPWAT [5]
EuroAquae Portal [6]
Global Hydrology Resource Center [7] (GHRC)
Global Runoff Data Center [8] (GRDC)
hydroinformatics.org [9]
HYPE OSC project [10]
International Association for Hydro-Environment Engineering and Research [11] (IAHR)
International Association of Hydrological Sciences [12] (IAHS)
International Conference on Hyrdoinformatics [13] (HIC)
International Water Association [14] (IWA)
Journal of Hyrdoinformatics [15]
Hydroinformatics 40

Notes
This article reuses a few elements from the Wikipedia article [16].

References
[1] http:/ / limswiki. org/ index. php?title=Hydroinformatics& action=edit
[2] http:/ / books. google. com/ books?id=Dr4PAQAAIAAJ
[3] http:/ / books. google. com/ books?id=pYPNHUdJvGkC& pg=PA39
[4] http:/ / www. fao. org/ nr/ water/ aquastat/ main/ index. stm
[5] http:/ / www. fao. org/ nr/ water/ infores_databases_cropwat. html
[6] http:/ / www. euroaquae. org/
[7] http:/ / ghrc. msfc. nasa. gov/
[8] http:/ / www. bafg. de/ GRDC/ EN/ Home/ homepage_node. html
[9] http:/ / www. hydroinformatics. org/
[10] http:/ / hype. sourceforge. net/
[11] http:/ / www. iahr. org/ site/ cms/ contentChapterView. asp?chapter=1
[12] http:/ / iahs. info/
[13] http:/ / hic2014. org/
[14] http:/ / www. iwahq. org/
[15] http:/ / www. iwaponline. com/ jh/ toc. htm
[16] http:/ / en. wikipedia. org/ wiki/ Hydroinformatics

Imaging informatics
Imaging informatics (also known as
radiology informatics or medical imaging
informatics) involves the intersection
between health informatics and
bioinformatics that aims to improve the
efficiency, accuracy, usability, and
reliability of medical imaging services
within the context of the healthcare
environment. "Notably, medical imaging
informatics addresses not only the images
themselves, but encompasses the associated
data to understand the context of the
imaging study; to document observations;
and to correlate and reach new conclusions
about a disease and the course of a medical
problem."

More specifically it is devoted to the study

of how information about and contained
within medical images is acquired, stored, This example from the late 1990s shows how data from magnetic resonance
imaging (MRI) could be transformed into a 3D rendering of the brain using
exchanged, analyzed, and enhanced
informatics tools like the VOXEL-MAN program.
throughout the medical enterprise. Medical
images must be in a standard, symbolic, and
reproducible format for proper acquisition and storage. Computer-related transmission protocols like TCP/IP, HTTP,
Imaging informatics 41

and DICOM as well as organized, sensical transaction diagrams are required for proper data exchange. And because
of all those protocols and standards, software can be created and utilized to analyze, enhance, and even mine medical
images for useful real-world healthcare data.
As radiology is an inherently data-intensive and technology-driven specialty of medicine, radiologists have become
leaders in imaging informatics. However, with the proliferation of digitized images to other fields such as
cardiology, dermatology, surgery, gastroenterology, obstetrics, gynecology, and pathology, advances in imaging
informatics are also being tested and applied in other areas of medicine.

Diagnostic imaging modalities

Medical images created, studied, and mined in imaging informatics come from several modalities:
Projection radiology utilizes X-rays to provide a grayscale image representing X-ray attenuation. The advantages of
it include being fast, easy to perform, and inexpensive. Disadvantages include problems with low-contrast
differentiations, image interpretation, and the use of ionizing radiation.
Fluorography utilizes a continuous low-power X-ray beam to provide a grayscale "movie" for real-time feedback. It
has the advantage of capturing movement-based measurements for barium studies or placement of catheters. It's
primary disadvantage is in the quality of the radiograph.
Computed tomography (CT) utilizes a moving collimated X-ray beam and a series of detectors to produce a digital
image based on the X-ray attenuation of tissues. It has the advantage of providing finer resolutions, especially among
tissues with similar densities. Disadvantages include high costs, the propensity for high-density artifacts, and the use
of high doses of ionizing radiation.
Magnetic resonance imaging (MRI) utilizes a high-intensity magnetic field with controlled radiofrequency pulses
to provide a grayscale image based on the magnetic properties of nuclei in the tissues of the body. Advantages
include excellent soft tissue contrast and resolution, can image on any plane, and doesn't use ionizing radiation.
Disadvantages include high costs, lengthy scan times, and an inability to show calcification.
Positron emission tomography (PET) utilizes X-ray or gamma-ray emitting radioisotopes placed into the body,
their decay measured as pulses of light using photomultiplier tubes, which is then converted into a grayscale image.
This method has the advantage of producing fine targeted measurements of chemical-physiologic tissue function.
The high cost and need for a cyclotron to produce the radioisotopes pose challenges to some medical facilities.
Ultrasound utilizes high-frequency sound waves from a transducer, which also receives reflected sound and
converts it to an electrical signal and then a grayscale image. Ultrasound has the benefit of being low-cost, safe, and
useful for analyzing soft tissues like the kidneys, liver, and pancreas. Disadvantages include its operator dependence
and its inability to render quality images in obese patients.
Visible light is used in some cases, though with limited practicality. It's most often used in the imaging of tissues in
light microscopy and imaging the retina.
Imaging informatics 42

Application
Imaging informatics can help tackle problems and tasks such as the following:
the creation and management of picture archiving and communication systems (PACS) and component systems
the embedding of medical images in electronic medical records
the development of radiology information systems (RIS)
the acquisition of images from medical devices
the development of image processing and enhancement software
the 3D visualization of medical imaging data
the integration of speech recognition into imaging apps for quicker reporting turnaround
the design of imaging facilities
the development of imaging vocabularies and ontologies
the mining of data from medical imaging databases
the development of DICOM, HL7, and other standards

Informatics
A portion of what imaging informatics does involves the technology surrounding the mentioned diagnostic imaging
modalities, including transfer and storage of their digital output. PACS have began playing an important role in
hospitals and other medical environments as early as the 1990s, helping to provide affordable digital storage and
distribution of medical images from numerous modalities. Another important part of imaging informatics includes
the development of software to view, enhance, and analyze output from those modalities. The RIS has played an
important part in that for sure, though open-source image viewing and analysis tools like dcm4che2, OsiriX, and ITK
have also broadened the scope and availability of informatics tools available to technicians and researchers. Of
course, interoperability among the software, PACS, RIS, and even the hospital information system (HIS) are vital
and benefited by protocols and standards like DICOM and HL7.

External links
American Board of Imaging Informatics [1] (ABII)
imagescience.org [2]
Medical Imaging & Technology Alliance [3] (MITA)
MedPix [4]
MyPACS.net [5]
Open Bio Image Alliance [6] (OBIA)
Society for Imaging Informatics in Medicine [7] (SIIM)
Society for Imaging Science and Technology [8] (IS&T)
Imaging informatics 43

Notes
This article reuses an element or two from the Wikipedia article [9].

References
[1] https:/ / www. abii. org/
[2] http:/ / www. imagescience. org/
[3] http:/ / www. medicalimaging. org/
[4] http:/ / rad. usuhs. edu/ medpix/ index. html
[5] http:/ / www. mypacs. net/
[6] http:/ / www. openbioimage. org/
[7] http:/ / siim. org/
[8] http:/ / www. imaging. org/ ist/ index. cfm
[9] http:/ / en. wikipedia. org/ wiki/ Imaging_informatics

Public health informatics

Public health informatics has been
defined as "the systematic application
of information and computer science
and technology to public health
practice, research, and learning." Like
other types of informatics, public
health informatics is a
multidisciplinary field, involving the
studies of informatics, computer
science, psychology, law, statistics,
epidemiology, and microbiology.
Collecting and utilizing vital statistics data is only one of many applications of public
In 2000, researcher William A. health informatics.
Yasnoff and his colleagues identified
four key aspects that differentiate public health informatics from medical informatics and other informatics specialty
areas. Public health informatics:
1. focuses on "applications of information science and technology that promote the health of populations as opposed
to the health of specific individuals."
2. focuses on "applications of information science and technology that prevent disease and injury by altering the
conditions or the environment that put populations of individuals at risk."
3. "explore[s] the potential for prevention at all vulnerable points in the causal chains leading to disease, injury, or
disability; applications should not be restricted to particular social, behavioral, or environmental contexts."
4. "reflect[s] the governmental context in which public health is practiced."

History
Before the advent of the Internet, public health data, like other healthcare and business data, were collected on paper
forms and stored centrally at the relevant public health agency. As computers became more commonplace, some data
and information would be computerized, requiring a distinct data entry process, storage in various file formats, and
analysis by mainframe computers using standard batch processing. With the coming of the Internet and cheaper
large-scale storage technologies, public health agencies with sufficient resources began transitioning to
web-accessible collections of public health data, and, more recently, to automated messaging of the same
Public health informatics 44

information.

Application
In the United States and other parts of the world, public health informatics is practiced by individuals in public
health agencies at the national, state, and larger local health jurisdiction levels. Additionally, research and training in
public health informatics takes place at a variety of academic institutions. In the United States, the bulk of public
health informatics activities takes place at the state and local level, in the state departments of health and the county
or parish departments of health. In other parts of the world the bulk of activities may occur at a national level, with
local jurisdictions reporting directly to an appropriate government or health-related entity. Activities may include:
collecting and storing vital statistics such as birth and death records.
collecting reported communicable disease cases from doctors, hospitals, and laboratories for infectious disease
surveillance.
sharing infectious disease statistics and trends with other entities, including the public.
collecting child immunization and lead screening information.
collecting and analyzing emergency room data to detect early evidence of biological threats.
collecting hospital capacity information to allow for planning of responses in case of emergencies.
As part of the collection and application of public health data, several challenges still exist. Some entities may
simply not be aware they need to report data to other entities. A lack of resources of either the reporter or collector
may also hinder reporting and sharing of data. In some parts of the world, a lack of interoperability of data
interchange formats (which can be at the purely syntactic or at the semantic level) may lead to under- or
non-reported public health data. Finally, variations in reporting requirements across the states, territories, and
localities pose challenges, which itself may lead to variability of incoming data to public health jurisdictions,
requiring greater data quality standards.

Informatics
Due to the complexity and variability of public health data, like health care data generally, the issue of data modeling
presents a particular challenge. Flat data sets for statistical analysis were the norm; however, today's requirements of
interoperability and integrated sets of data across the public health enterprise require more sophistication. The
relational database is increasingly the norm in public health informatics. Designers and implementers of the many
sets of data required for various public health purposes must find a workable balance between very complex and
abstract data models and simplistic, ad hoc models that untrained public health practitioners come up with and feel
capable of working with.
Another challenge is found in the need to extract usable public health information from the mass of available
heterogeneous data. The public health informaticist is thus required to become familiar with a variety of analysis
tools, ranging from business intelligence tools to produce routine or ad hoc reports, to sophisticated statistical
analysis tools and geographical information systems (GIS) to expose the geographical dimension of public health
trends.

In the United States

The Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia has played an important role in public
health and infectious disease informatics. The agency's Center for Surveillance, Epidemiology and Laboratory
Services (CSELS; formerly OSELS) and its Division of Health Informatics and Surveillance (DHIS; formerly
PHITPO and PHSIPO) has focused on advancing the state of information science in these realms, applying digital
information technologies to aid in the detection and management of diseases and syndromes in individuals and
populations. The CDC also created the National Electronic Disease Surveillance System (NEDSS), which includes a
Public health informatics 45

free comprehensive web and message-based reporting system called the NEDSS Base System (NBS), used for
managing and transmitting reportable disease data.
Since 2002, the CDC has promoted the idea of the Public Health Information Network to facilitate the transmission
of data from various partners in the health care industry and elsewhere (hospitals, clinical and environmental
laboratories, doctors' practices, pharmacies) to local health agencies, then to state health agencies, and then to the
CDC. At each stage the entity must be capable of receiving the data, storing it, aggregating it appropriately, and
transmitting it to the next level. To promote interoperability between the NBS and other informatics systems, the
CDC has also encouraged the adoption of several standard vocabularies and messaging formats from the health care
world. The most prominent of these are the Health Level 7 (HL7) standards for health care messaging, the LOINC
system for encoding laboratory test and result information, and the Systematized Nomenclature of Medicine
(SNOMED) vocabulary of health care concepts.
A typical example of data transmissions to the CDC would be infectious disease data, which hospitals, labs, and
doctors are legally required to report to local health agencies. The local health agencies must then report to their state
public health department and the states must report in aggregate form to the CDC. Among other uses of this received
data, the CDC publishes the Morbidity and Mortality Weekly Report (MMWR), "the agencys primary vehicle for
scientific publication of timely, reliable, authoritative, accurate, objective, and useful public health information and
recommendations."

Notes
Some elements of this article are reused from the Wikipedia article [1].

References
[1] http:/ / en. wikipedia. org/ wiki/ Public_health_informatics
 46

4. All about LIMS and LIS

Laboratory information management system

Sometimes referred to as a laboratory
information system (LIS) or laboratory
management system (LMS), a
laboratory information management
system (LIMS) is a software-based
laboratory and information
management system that offers a set of
key features that support a modern
laboratory's operations. Those key
features include but are not limited
to workflow and data tracking
support, flexible architecture, and
smart data exchange interfaces, which
fully "support its use in regulated
environments." The features and uses
of a LIMS have evolved over the years Laboratories around the world depend on a LIMS to manage data, assign rights, manage
from simple sample tracking to an inventory, and more.

enterprise resource planning tool that

manages multiple aspects of laboratory informatics.

Due to the rapid pace at which laboratories and their data management needs shift, the definition of LIMS has
become somewhat controversial. As the needs of the modern laboratory vary widely from lab to lab, what is needed
from a laboratory information management system also shifts. The end result: the definition of a LIMS will shift
based on who you ask and what their vision of the modern lab is. Dr. Alan McLelland of the Institute of
Biochemistry, Royal Infirmary, Glasgow highlighted this problem in the late 1990s by explaining how a LIMS is
perceived by an analyst, a laboratory manager, an information systems manager, and an accountant, "all of them
correct, but each of them limited by the users' own perceptions."
Historically the LIMS, LIS, and process development execution system (PDES) have all performed similar
functions. Historically the term "LIMS" has tended to be used to reference informatics systems targeted for
environmental, research, or commercial analysis such as pharmaceutical or petrochemical work. "LIS" has tended to
be used to reference laboratory informatics systems in the forensics and clinical markets, which often required
special case management tools. The term "PDES" has generally applied to a wider scope, including, for example,
virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.
In recent times LIMS functionality has spread even farther beyond its original purpose of sample management.
Assay data management, data mining, data analysis, and electronic laboratory notebook (ELN) integration are all
features that have been added to many LIMS, enabling the realization of translational medicine completely within a
single software solution. Additionally, the distinction between a LIMS and a LIS has blurred, as many LIMS now
also fully support comprehensive case-centric clinical data.
Laboratory information management system 47

History of LIMS
Up until the late 1970s, the management of laboratory samples and the associated analysis and reporting were
time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to
streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few
individual laboratories, while some enterprising entities at the same time sought to develop a more commercial
reporting solution in the form of special instrument-based systems.
In 1982 the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered
laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew,
industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds
through LIMS-related conferences. By 1988 the second-generation commercial offerings were tapping into relational
databases to expand LIMS into more application-specific territory, and International LIMS Conferences were in full
swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the
early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to
implement better data processing and exchanges.
By 1995 the client/server tools had developed to the point of allowing processing of data anywhere on the network.
Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the
confines of the laboratory. From 1996 to 2002 additional functionality was included in LIMS, from wireless
networking capabilities and georeferencing of samples, to the adoption of XML standards and the development of
Internet purchasing.
As of 2012, some LIMS have added additional characteristics that continue to shape how a LIMS is defined.
Examples include the addition of clinical functionality, electronic laboratory notebook (ELN) functionality, as well a
rise in the software as a service (SaaS) distribution model.

Technology

Laboratory information management operations

The LIMS is an evolving concept, with new features and functionality being added often. As laboratory demands
change and technological progress continues, the functions of a LIMS will likely also change. Despite these changes,
a LIMS tends to have a base set of functionality that defines it. That functionality can roughly be divided into five
laboratory processing phases, with numerous software functions falling under each:
the reception and log in of a sample and its associated customer data
the assignment, scheduling, and tracking of the sample and the associated analytical workload
the processing and quality control associated with the sample and the utilized equipment and inventory
the storage of data associated with the sample analysis
the inspection, approval, and compilation of the sample data for reporting and/or further analysis
There are several pieces of core functionality associated with these laboratory processing phases that tend to appear
in most LIMS:
Laboratory information management system 48

Sample management

The core function of LIMS has traditionally been the

management of samples. This typically is initiated
when a sample is received in the laboratory, at which
point the sample will be registered in the LIMS. This
registration process may involve accessioning the
sample and producing barcodes to affix to the sample
container. Various other parameters such as clinical
or phenotypic information corresponding with the
sample are also often recorded. The LIMS then
tracks chain of custody as well as sample location.
Location tracking usually involves assigning the
sample to a particular freezer location, often down to
the granular level of shelf, rack, box, row, and
column. Other event tracking such as freeze and thaw A lab worker matches blood samples to documents. With a LIMS, this
cycles that a sample undergoes in the laboratory may sort of sample management is made more efficient.
be required.

Modern LIMS have implemented extensive configurability, as each laboratory's needs for tracking additional data
points can vary widely. LIMS vendors cannot typically make assumptions about what these data tracking needs are,
and therefore vendors must create LIMS that are adaptable to individual environments. LIMS users may also have
regulatory concerns to comply with such as CLIA, HIPAA, GLP, and FDA specifications, affecting certain aspects
of sample management in a LIMS solution. One key to compliance with many of these standards is audit logging of
all changes to LIMS data, and in some cases a full electronic signature system is required for rigorous tracking of
field-level changes to LIMS data.

Instrument and application integration

Modern LIMS offer an increasing amount of integration with laboratory instruments and applications. A LIMS may
create control files that are "fed" into the instrument and direct its operation on some physical item such as a sample
tube or sample plate. The LIMS may then import instrument results files to extract data for quality control
assessment of the operation on the sample. Access to the instrument data can sometimes be regulated based on chain
of custody assignments or other security features if need be.
Modern LIMS products now also allow for the import and management of raw assay data results. Modern targeted
assays such as qPCR and deep sequencing can produce tens of thousands of data points per sample. Furthermore, in
the case of drug and diagnostic development as many as 12 or more assays may be run for each sample. In order to
track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and
import creation layer, while maintaining a high level of overall performance. Some LIMS products address this by
simply attaching assay data as BLOBs to samples, but this limits the utility of that data in data mining and
downstream analysis.

Electronic data exchange

The exponentially growing volume of data created in laboratories, coupled with increased business demands and
focus on profitability, have pushed LIMS vendors to increase attention to how their LIMS handles electronic data
exchanges. Attention must be paid to how an instrument's input and output data is managed, how remote sample
collection data is imported and exported, and how mobile technology integrates with the LIMS. The successful
transfer of data files in Microsoft Excel and other formats, as well as the import and export of data to Oracle, SQL,
and Microsoft Access databases is a pivotal aspect of a the modern LIMS. In fact, the transition "from proprietary
Laboratory information management system 49

databases to standardized database management systems such as Oracle ... and SQL" has arguably had one of the
biggest impacts on how data is managed and exchanged in laboratories.

Additional functions
Aside from the key functions of sample management, instrument and application integration, and electronic data
exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited
to:
audit management
fully track and maintain an audit trail
barcode handling
assign one or more data points to a barcode format; read and extract information from a barcode
chain of custody
assign roles and groups that dictate access to specific data records and who is managing them
compliance
follow regulatory standards that affect the laboratory
customer relationship management
handle the demographic information and communications for associated clients
document management
process and convert data to certain formats; manage how documents are distributed and accessed
instrument calibration and maintenance
schedule important maintenance and calibration of lab instruments and keep detailed records of such activities
inventory and equipment management
measure and record inventories of vital supplies and laboratory equipment
manual and electronic data entry
provide fast and reliable interfaces for data to be entered by a human or electronic component
method management
provide one location for all laboratory process and procedure (P&P) and methodology to be housed and
managed
personnel and workload management
organize work schedules, workload assignments, employee demographic information, and financial
information
quality assurance and control
guage and control sample quality, data entry standards, and workflow; reports
create and schedule reports in a specific format; schedule and distribute reports to designated parties
time tracking
claculate and maintain processing and handling times on chemical reactions, workflows, and more
Laboratory information management system 50

LIMS architecture and delivery methods

A LIMS has utilized many architectures and distribution models over the years. As technology has changed, how a
LIMS is installed, managed, and utilized has also changed with it.
The following represents architectures which have been utilized at one point or another:

Thick-client
A thick-client LIMS is a more traditional client/server architecture, with some of the system residing on the
computer or workstation of the user (the client) and the rest on the server. The LIMS software is installed on the
client computer, which does all of the data processing. Later it passes information to the server, which has the
primary purpose of data storage. Most changes, upgrades, and other modifications will happen on the client side.
This was one of the first architectures implemented into a LIMS, having the advantage of providing higher
processing speeds (because processing is done on the client and not the server) and slightly more security (as access
to the server data is limited only to those with client software). Additionally, thick-client systems have also provided
more interactivity and customization, though often at a greater learning curve. The disadvantages of client-side
LIMS include the need for more robust client computers and more time-consuming upgrades, as well as a lack of
base functionality through a web browser. The thick-client LIMS can become web-enabled through an add-on
component.

Thin-client
A thin-client LIMS is a more modern architecture which offers full application functionality accessed through a
device's web browser. The actual LIMS software resides on a server (host) which feeds and processes information
without saving it to the user's hard disk. Any necessary changes, upgrades, and other modifications are handled by
the entity hosting the server-side LIMS software, meaning all end-users see all changes made. To this end, a true
thin-client LIMS will leave no "footprint" on the client's computer, and only the integrity of the web browser need be
maintained by the user. The advantages of this system include significantly lower cost of ownership and fewer
network and client-side maintenance expenses. However, this architecture has the disadvantage of requiring
real-time server access, a need for increased network throughput, and slightly less functionality. A sort of hybrid
architecture that incorporates the features of thin-client browser usage with a thick client installation exists in the
form of a web-based LIMS.
Some LIMS vendors are beginning to rent hosted, thin-client solutions as "software as a service" (SaaS). These
solutions tend to be less configurable than on premise solutions and are therefore considered for less demanding
implementations such as laboratories with few users and limited sample processing volumes.
Another implementation of the thin client architecture is the maintenance, warranty, and support (MSW) agreement.
Pricing levels are typically based on a percentage of the license fee, with a standard level of service for 10 concurrent
users being approximately 10 hours of support and additional customer service, at a roughly $200 per hour rate.
Though some may choose to opt out of an MSW after the first year, it's often more economical to continue the plan
in order to receive updates to the LIMS, giving it a longer life span in the laboratory.

Web-enabled
A web-enabled LIMS architecture is essentially a thick-client architecture with an added web browser component. In
this setup, the client-side software has additional functionality that allows users to interface with the software
through their device's browser. This functionality is typically limited only to certain functions of the web client. The
primary advantage of a web-enabled LIMS is the end-user can access data both on the client side and the server side
of the configuration. As in a thick-client architecture, updates in the software must be propagated to every client
machine. However, the added disadvantages of requiring always-on access to the host server and the need for
cross-platform functionality mean that additional overhead costs may arise.
Laboratory information management system 51

Web-based
Arguably one of the most confusing architectures, web-based LIMS architecture is a hybrid of the thick- and
thin-client architectures. While much of the client-side work is done through a web browser, the LIMS also requires
the additional support of Microsoft's .NET Framework technology installed on the client device. The end result is a
process that is apparent to the end-user through the Microrosoft-compatible web browser, but perhaps not so
apparent as it runs thick-client-like processing in the background. In this case, web-based architecture has the
advantage of providing more functionality through a more friendly web interface. The disadvantages of this setup are
more sunk costs in system administration and support for Internet Explorer and .NET technologies, and reduced
functionality on mobile platforms.

LIMS configurability
LIMS implementations are notorious for often being lengthy and costly. This is due in part to the diversity of
requirements within each lab, but also to the inflexible nature of LIMS products for adapting to these widely varying
requirements. Newer LIMS solutions are beginning to emerge that take advantage of modern techniques in software
design that are inherently more configurable and adaptable particularly at the data layer than prior solutions.
This means not only that implementations are much faster, but also that the costs are lower and the risk of
obsolescence is minimized.

The distinction between a LIMS and a LIS

Up until recently, LIMS and LIS have exhibited a few key differences, making them noticeably separate entities:
1. A LIMS traditionally has been designed to process and report data related to batches of samples from biology labs,
water treatment facilities, drug trials, and other entities that handle complex batches of data. A LIS has been
designed primarily for processing and reporting data related to individual patients in a clinical setting.
2. A LIMS needs to satisfy good manufacturing practice (GMP) and meet the reporting and audit needs of the U.S.
Food and Drug Administration and research scientists in many different industries. A LIS, however, must satisfy the
reporting and auditing needs of hospital accreditation agencies, HIPAA, and other clinical medical practitioners.
3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with
mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric
settings (dealing with "subjects" and "specimens") and clinical labs.
However, as of 2012 these distinctions have faded somewhat as some LIMS vendors have adopted the case-centric
information management normally reserved for a LIS, blurring the lines between the two components further.
Thermo Scientific's Clinical LIMS is a recent example of this merger of LIMS with LIS, with Dave Champagne,
informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of
the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry
is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."
STARLIMS Corporation's STARLIMS product is another recent example of this LIMS/LIS merger. With the
distinction between the two entities becoming less clear, discussions within the laboratory informatics community
have raised the question of whether or not the two entities should be considered the same.
Laboratory information management system 52

Standards affecting LIMS

A LIMS' development and use is affected by standards such as:
Title 21 CFR Part 11 from the Food and Drug Administration (United States)
ISO 17025
ISO 15189
Good laboratory practice

LIMS vendors
See the LIMS vendor page for a list of LIMS vendors past and present.

Further reading
Gibbon, G.A. (1996). "A brief history of LIMS" [1] (PDF). Laboratory Automation and Information Management
32 (1): 15. doi [2]:10.1016/1381-141X(95)00024-K [2].
Wood, Simon (September 2007). "Comprehensive Laboratory Informatics: A Multilayer Approach" [3] (PDF).
American Laboratory. p. 1.

References
[1] http:/ / www. sciencedirect. com/ science/ article/ pii/ 1381141X9500024K
[2] http:/ / dx. doi. org/ 10. 1016%2F1381-141X%2895%2900024-K
[3] http:/ / www. starlims. com/ Intl/ AL-Wood-Reprint-9-07. pdf

LIMS feature
You can find a listing of all LIMS vendors and by extension, the features their products offer on the LIMS vendor page.

A LIMS feature is one or more pieces of functionality that appear within a laboratory information management
system (LIMS).
The LIMS is an evolving concept, with new features and abilities being introduced every year. As laboratory
demands change and technological progress continues, the functions of a LIMS will also change. Yet like the
automobile, the LIMS tends to have a base set of functionality that defines it. That functionality can roughly be
divided into five laboratory processing phases, with numerous software functions falling under each:
the reception and log in of a sample and its associated customer data
the assignment, scheduling, and tracking of the sample and the associated analytical workload
the processing and quality control associated with the sample and the utilized equipment and inventory
the storage of data associated with the sample analysis
the inspection, approval, and compilation of the sample data for reporting and/or further analysis
Of course, there are LIMS features that are difficult to categorize under any of these phases. Such features often
contribute to the entire LIMS and how it's utilized. For example, multilingual support appears in LIMS like Assaynet
Inc.'s LIMS2010 and Two Fold Software's Qualoupe LIMS, allowing users to interact with the LIMS in more than
one language. Some functionality may also overlap several laboratory phases, making it difficult to firmly classify.
The features described below come from an analysis of freely available LIMS product information on vendor
websites. An attempt was made to discover the features most utilized in vendors' LIMS products and collect
information on those features for each LIMS. Not every possible feature is referenced here; some LIMS products fill
LIMS feature 53

specific niches, utilizing unique functionality to solve a specific problem.

That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs
under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated
manner, however, some liberty has been taken in the categorizing of features.

Sample, inventory, and data management

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

Sample login and management

Sample accessioning and management is one of the core functions a modern LIMS is tasked with, whether it's in a
manufacturing, water treatment, or pharmaceutical laboratory. As such, researchers who work in these types of labs
are unable to complete their experiment-based goals without an effective method of managing samples. The process
of sample management for experiments includes, but is not limited to:
storing related sample information, including aliquot numbers, dates, and external links
setting user alerts for sample status
creating and documenting viewable sample container schemas with name and status
assigning sample access rights
assigning custom sample ID numbers based on a specification
Additional functionality that could potentially fall under this feature:
utilizing a unique ID system
barcoding of samples
defining sample points and series
creating data associations for samples - such as pedigree for sample/aliquot relationships or relationships based on
experiment, etc.
issuing sample receipts

Sample tracking
For most laboratory personnel, knowing that a sample has arrived to
the lab isn't good enough; they need to know where it's located and
what is being done with it. Enter the sample tracking feature. Without
it, many problems arise. In the forensic world, for example, many
samples are linked to a criminal investigation. In this case,
misidentification, contamination, or duplication can become significant
issues: a lost sample is essentially missing evidence, while a duplicated
sample can render it useless as evidence.
After sample reception and its initial handling procedures, many LIMS
can then track sample location as well as chain of custody. Location
tracking usually involves assigning the sample to a particular freezer
location, often down to the granular level of shelf, rack, box, row, and
column. The process of tracking a sample has become more
streamlined with increasing support of 2-D barcode technology. While Where's sample 20110512_122GJH? Sample
tracking functionality will let you know which
handwritten labels were the norm, now barcode support in a LIMS can
lab oven it's in.
"tie together a vast amount of information, clearly relating each sample
LIMS feature 54

to a specific case." Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory
may also be required. As each laboratory's needs for tracking additional data points can vary widely, many modern
LIMS have implemented extensive configurability to compensate for varying environments.
The functionality of sample tracking strongly ties into the audit trail and chain of custody features of a LIMS.

Sample and result batching

What is batching? The United States Environmental Protection Agency (EPA) defines a batch as "a group of samples
which behave similarly with respect to the sampling or testing procedures being employed and which are processed
as a unit." This definition can be applied to many laboratories which handle large quantities of samples for some
form of analysis or processing. A LIMS that has the ability to check in, link, and track groups of samples across one
or multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples
or groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the
benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.

Task and event scheduling

Within the context of a LIMS, the ability to schedule a task or event is a natural extension of how work was done in
a laboratory before the advent of data management systems. Workloads are assigned to technicians, maintenance
schedules are created and followed, and research deadlines must be observed. While these tasks have in the past been
performed without LIMS, a modern data management system can now optimize those tasks and provide additional
scheduling functionality to streamline the operation of a lab. Autoscribe Ltd., for example, offers a scheduling
module for its LIMS that allows users to automatically schedule multiple jobs, data backups, alarms, and reports.
Some LIMS like LabWare, Inc.'s LabWare LIMS offer multiple types of schedulers that match to the particular
functions of a research laboratory. Additional functionality within this feature includes the ability to configure
automated assignments of analysis requests, establish recurring events, and in most cases, create printable schedules.
Examples of tasks and events that can feasibly be scheduled in a LIMS include:
registration of received samples into the system
production of reports
creation and sending of e-mails and alerts
maintenance of equipment
assignment of workloads to personnel

Option for manual result entry

While many LIMS vendors tout the ability of their product to automate the entry of results into the LIMS database,
the need for manual data entry of analysis results still exists. This feature is important to laboratories obtaining
analysis results from multiple sources, including non-digital paper-based results and instruments that can't be
connected to the LIMS. Additional functionality associated with this feature includes a customizable spell check
dictionary and the ability to add comments, notes, and narratives to most anything in the LIMS.
LIMS feature 55

Multiple data viewing methods

Laboratories produce data, and LIMS exist to help manage that data. Additionally, even before the existence of
LIMS, scientists have had a corresponding need for visually representing data. Today a LIMS can not only collect
and analyze data from samples, but it also can represent that data in reports, graphs, gradients, and spreadsheets.
Depending on the LIMS, more than one way to visually represent the data may exist.
Some laboratory information management systems take a very specialized approach to data views. For example,
Biomatters Ltd.'s Geneious and Geneious Pro offer multiple methods of viewing complicated sequence analysis data,
including 3-D structuring and representations of plasmid vectors.

Data and trend analysis

Sample experimentation and analysis plays an
important part of laboratory informatics, helping
laboratories make better sense of their experiments
and reach valuable conclusions about them. While
this important phase of laboratory work has often
been done externally from the LIMS, it's now more
Some LIMS allow users to analyze sample data directly from the common to see basic analysis tools being included.
software. Such tools allow raw data to be imported directly to
the LIMS, which then can store, process, and report
information about it. Additionally, calculations and functions used in the analysis are typically definable and editable
for further flexibility.

As with the feature "multiple data viewing methods," data and trend analysis is also increasingly important in
laboratories that have very specialized data management needs. When even in 2009 genetic scientists in large- and
medium-sized sequencing and core centers were voicing concerns about "a lack of adequate vendor-supported
software and laboratory information management systems (LIMS),", today data management options like the
previously mentioned Geneious Pro are starting to emerge, offering the ability to perform specialized analytical tasks
for the sequencing industry.
As sample experimentation and data analysis are important parts of most if not all laboratories, such functionality
which has often come in the form of a separate application or analysis device will likely continue to merge into
LIMS and other data management solutions.

Data and equipment sharing

Aside from data storage and sample registration, a modern LIMS' major contribution to the laboratory is aiding in the
sharing of experiment results, reports, and other data types with those who need it most. Rather than pieces of
information becoming misplaced or forgotten in laboratory notebooks, the LIMS makes it easier to share sample test
results and increase the efficiency of collaboration inside and outside the laboratory. Yet data is more than just
sample test results; it also can come in the form of charts, reports, policy and procedure, and other documents.
Additionally, the need for controlling who has access to those types of data is also an important consideration. As
such, this feature is at least partially tied to other features like document management and configurable security.
LIMS feature 56

Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for LIMS
end users, there are at times options that are either omitted or unanticipated. This has traditionally required the end
user to contact the vendor and ask if the needed option(s) can be added in the next release. However, some modern
LIMS vendors have responded instead by adding functionality that gives end users and/or LIMS administrators more
control over the user interface.
Aspects of the LIMS' user interface that are becoming more customizable by the end user include:
system nomenclature
equations used in calculations
data and universal fields
appearance of the interface and/or menus
primary system language
the LIMS source code, especially if in a non-proprietary format

Query capability
As was the case before the advent of databases and
electronic data management solutions, today researchers
must search through sample results, experiment notes,
and other types of data to better draw conclusions about
their research. Whereas this used to mean browsing
through laboratory notebooks, Excel spreadsheets, or
Access databases, now powerful query tools exists within
data management tools like a LIMS. Not only can data be
searched for based on name, number, or vendor, LIMSs
like eBioSys' eLab and Mountain States Consulting's
MSC-LIMS allow for queries of attached meta-data like Advanced query tools allow researchers to better complete project
objectives.
user ID, project number, task number, sample type,
location, and collection date. Finally, as LIMS continue
to include both sample management and experimental data management functionality, queries become more
powerful in general as now sample and experiment can be matched together in one database.

Query functionality often includes the ability to:

search both transactional data and archived data tables
search multiple databases via an application programming interface (API) or open database connectivity (ODBC)
connection
filter and sort data
create ad-hoc queries

Import data
Data can originate from numerous places in the laboratory. The ability to import that data into a LIMS can be
beneficial, especially when an instrument can't be connected or an external client provides a data feed independent of
the LIMS. Some LIMS like Bridge-Soft's QMS even allow to cross-reference laboratory nomenclature from received
data sources with the recipient's. And of course instrument interfacing allows for even more importation options.
Additional data validation procedures may be applied to the imported data to guarantee information homogeneity.
Additionally, some LIMS may allow for the import and integration of non-normalized legacy data tables with LIMS
data tables into a single database.
LIMS feature 57

Internal file or data linking

This feature allows LIMS users to link together reports, protocols, sample results, and more, providing greater
contextual clarity to projects. Examples include:
linking a sample batch to a test or sample preparation methodology
linking a test process to a particular customer
linking a report to a sample batch
linking a group of test results to a raw data file
linking an image to a work order
linking all lab results with the correct reporting test method

External file or data linking

This feature allows LIMS users to link together data and files in the LIMS with data, files, and customers outside the
scope of the LIMS. Examples include:
linking data files from chromatography equipment to synthesis data
linking equipment ID with an external annotation database
linking external standard operating procedure documents with an internal test specification

ELN support or integration

As a software replacement for more traditional paper laboratory notebooks, the electronic laboratory notebook
(ELN) has been important to laboratory functions. Yet the lines between ELN and LIMS began to blur in the 2000s,
with both types of software incorporating features from the other. The result today is some LIMS either include
traditional ELN functionality or link physical laboratory notebook references to data in the LIMS.

Export to MS Excel
While Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and
LIMS occurred in the late 1990s and early 2000s. Additional concerns with the difficulties of Excel's validation and
compliance with FDA 21 CFR Part 11 and other regulations have led many labs to turn to data management
solutions that are easier to validate. Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel
integration or data exportation in Excel format is a real need for LIMS customers. LIMS with this feature allow raw,
processed, or imported data to be exported in the Excel format for further analysis and dissemination.

Raw data management

While not described as a feature on most LIMS vendor websites, a few indicate that their LIMS is capable of
managing (import, export, editing, etc.) data in its raw format for future analysis.

Data warehouse
A LIMS' data warehouse serves the important function of storing, extracting, and managing the data that laboratories
crank out for the purposes or analysis, reporting, and process management, typically separate from the primary
storage database. Data warehouses also offer the benefit of speeding up queries, making queries and data mining
more user-friendly, and smoothing out data gaps.
LIMS feature 58

Deadline control
Deadline control is functionality within a LIMS that allows users to manage and be notified of events that occur
within the laboratory. With this functionality users can also be notified of upcoming deadlines on anything from
sample analysis to license renewal.
Note that this functionality may also feasibly fall under the task and event scheduling or alarms features. As deadline
control seems to be advertised as a notable feature by only a few vendors, it seems even more likely that this
functionality is considered part of scheduling or alarms.

Production control
There are many types of businesses that produce goods, and in most cases there is a research laboratory involved at
some point in the process. This is especially true in the pharmaceutical and chemical industries, where production
measurements such as yield, volume, activity, and impurity are vital. As LIMSs have already recorded such
information during tests and analysis, the addition of production control functionality seems natural. Some LIMS
take a very active approach to this. For example, 2nd Sight Solutions' OhNo! features production control as major
functionality for the synthesis of radiopharmaceuticals. Other LIMS may have less pronounced production
functionality, while still offering the ability to track the production process in and out of the lab. And yet other
LIMSs like dialog's diaLIMS offer robust production-based functionality but as a module or add-on to the base
LIMS software.
The types of functionality that may fall under this feature include:
recipe management
consumable tracking
batch traceability
production planning
enterprise resource planning

Project and/or task management

Project and task management within a LIMS typically involves the scheduling of tasks to workers and organizing
associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and
event scheduling can also be found in project and task management, many LIMS include functionality beyond
scheduling that warrants the addition of the project and/or task management feature. This functionality includes:
job allocation and rescheduling
instrument workload tracking
time tracking
pending workload verification
priority setting
project-based workflow management
sample, batch, and document linking
work list sharing
recurring event management
LIMS feature 59

Inventory management
Laboratories use a wide array of inventory, from reagents
to glassware, from radiopharmaceuticals to laboratory
baths. With that comes the need to know how much/many
and the frequency of use. For this, most LIMS products
now include some sort of inventory management
functionality.

register origin, demographics of incoming materials

track used and in-use items via barcodes
track inventory reduction based on usage and shipping
out of the lab
create alerts for when items reach a certain stock level
calculate inventory cost and fluctuation LIMS can help laboratories keep track of their stock of reagents
manage transportation and routing and even streamline reordering of them.

manual incrementing/decrementing of items

track location and usage of laboratory equipment
assign storage locations
track forensic evidence
It should be noted that samples and electronic equipment may also be considered inventory, and thus there is likely
some functionality crossover with the sample management and instrument management features.

Document creation and management

Standard operation procedures, (SOPs), specifications, reports, graphs, images, and receipts are all collected and
used in the average laboratory. With a LIMS already designed to manage and store sample and experiment data, it
makes sense to include functionality to create, import, export, and manage other sorts of data files. As sample and
experimental data can be indexed, queried, and linked, so too can document data. Functionality of a typical
document management system includes the ability to:
upload and index documents
enforce version control
provide full text search
export to PDF or other relevant format
add documents as attachments

Case management
The laboratory information system (LIS) has played an important role in the case management tasks of
patient-centric and clinical laboratories. However, some LIMS have gained case management functionality,
effectively blurring the lines between LIS and LIMS.. Self-proclaimed LIMS products have emerged in the clinical,
public health, and veterinary industries, areas that have historically been served by LIS software. When also
considering the fields of law enforcement and forensic science, case management has an increasingly important role
in some LIMS. Functionality seen in the case management feature includes:
case accessioning and assignment
disease tracking
trend analysis
clinical history follow-up
out-of-range result alerts
LIMS feature 60

document and result association

evidence control
study management

Workflow management
Capturing workflow in the lab is becoming more
commonplace for the LIMS.
Workflow management is common in the laboratory, acting as a
graphical representation of planned sequential steps to either fully or
partially automate a process within the lab. Separate standards-based
workflow management systems (in the form of a software component)
have traditionally performed this task. However, in the 2000s LIMS
vendors began incorporating workflow management functionality into
their LIMS software, reducing the headaches that customization of a
LIMS often brought.
Modern commercial and open-source LIMS solutions often feature
workflow management functionality, including:
attribute definition of activities

definition of inputs and outputs of activities

assignment of documentation to activities
setting of quality control limits
dynamically modify workflow in case of future changes
receive notification of changes to the workflow
sending user-defined messages during the process

Specification management
Specification (spec) management is vital to not only the manufacturing and research industries but also to a host of
other laboratories requiring precise measurements and infallible test methods. Just as the ASTM offers standards and
specs for LIMS, so too do LIMS users have standards and specs for their laboratory. With spec management in place
within the LIMS, laboratories can then:
enforce standard operating procedures and business rules
create specs down to a project or sample level
validate recipes and procedures
accept or reject sample batches
document internal and external spec history
Note that some of the functionality of spec management may cross over into the realm of quality control and data
validation.

Customer and supplier management

Unless a laboratory is conducting internalized independent research, in most cases it will do business with external
entities such as contract labs, sample providers, equipment providers, and reagent suppliers. In some cases, even
internal employees may be considered a customer, necessitating documentation of who is using the system and in
what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be
more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases
may all at some point act as customers. In these cases, documenting these various points of contact and linking them
to samples, equipment, and tests becomes vital. Managing demographics, complaints, correspondence, and history
LIMS feature 61

are all feasible with customer management functionality. This process is often made simpler through the use of a
more context-neutral entity creation system, which allows for more flexible management of contacts.
This feature may also be referred to as contact management, an address book module, or a customer service module.

Billing management
While the finances of a laboratory are important, they've typically been handled separately as a business process.
However, some LIMS include additional functionality to make handling financial transactions and documentation of
all sorts possible within the LIMS. In theory, such functionality brings the possibility of keeping more of a
laboratory's data centrally located and queryable. This feature may include:
payment processing
expense reporting
price quotes
revenue management
workload tracking of billable hours
bill of materials
grant management

Quality, security, and compliance

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Regulatory compliance
The topic of whether or not a LIMS meets regulatory compliance is often a complex one. While Title 21 CFR Part
11 has arguably had the largest influence on a electronic data management system's compliance, other influential
standards have shaped the way LIMS and other systems handle and store data. Other compliance-based codes,
standards, and regulations include:
ASTM
ASCLD/LAB
Classified data
Freedom of information legislation (various)
GALP and GAMP
HIPAA
Health Level 7
ICD
ISO/IEC 17025
ISO 9000/9001
ISO/TS 16949
ODBC
TNI and NELAP
Title 40 CFR Part 3
With so many codes, standards, and regulations, LIMS consumers are advised to contact vendors with their user
requirements and ask how the vendor's software meets and/or exceeds those requirements.
LIMS feature 62

QA/QC functions
The quality management functions of a LIMS allow users to maintain a level of necessary quality across many of the
functions in a laboratory. From running quality assurance tests to ensuring employed researchers are proficient at
certain tasks, the QA/QC functionality of a LIMS is largely responsible for the output of consistent data and
manufactured products in and out of the lab.
Common functionality includes:
single or batch QA/QC tests
quality control charts and reports
proficiency testing
document management
instrument maintenance
data acceptance/rejection
certificates of analysis (COA)
data types defined by QC analysis

Performance evaluation
As document management becomes increasingly prevalent in LIMS, it only makes sense to also collate and store all
the documentation associated with employee training and certification. Changes to laboratory techniques, scientific
understanding, and business practices force researchers to learn, reevaluate, and demonstrate competency in order to
maintain quality levels in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics,
visit types, vendors, or test species can also be tracked and evaluated based on custom criteria. The performance
evaluation functionality of a LIMS makes this possible.
That functionality typically includes the ability to maintain training records and history, and also to link that training
to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or
certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical
effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range
based on tracked time, pre-determined milestones, or some other criteria.

Audit trail
As codes and regulations like Title 21 CFR Part 11 mandate "computer
systems (including hardware and software), controls, and attendant
documentation" utilize electronic signatures and audit trails, LIMS
developers must put serious thought into how their software handles
audit trail functionality. The audit trail documentation of the
sequence of activities that have affected an action must be thorough
and seamlessly integrated into the software.

Information recorded in the audit trail typically includes:

Whether validating sample data or an entire operator code
LIMS, maintaining an audit trail is an important
time stamp
part of 21 CFR Part 11 compliance.
location
case number
transaction type
amount and quantity prior to change
user notes
LIMS feature 63

Chain of custody
The chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly
regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital
part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their
evidence collection, retention, and disposal procedures. As with an audit trail, a laboratory depends on recorded
information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes, inventory
management, and configurable security roles all play an important part in maintaining chain of custody.

Configurable roles and security

Many roles exist within the laboratory setting, each with its own set of responsibilities. And just as the role an
individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort of
change necessitates a flexible and configurable security system, one that allows for the placement of individual
LIMS users into standardized security roles which provide role-specific access to certain LIMS functionality.
Additionally, as responsibilities change within roles, that same flexible configuration is necessary for assigning or
restricting access to certain LIMS functionality for each existing or newly created role.
Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be
assigned to roles, necessitating group assignments for security purposes. For example, a group of laboratory trainees
may only be given read-only access to the sample login and sample tracking functionality of the system through a
custom "Trainees" group role, while the head researcher of the lab may be given the "Administrator" role, which
allows that individual to access most if not all of the LIMS' functionality.

Data normalization
For the purposes of describing LIMS functionality, "data normalization" specifically refers to the process of ensuring
incoming/imported data into the LIMS is standardized to the same format of existing LIMS data.
Here's an example to better explain this issue. When a LIMS is initially configured, in most if not all cases a clear
standard can be set for how logged samples and their associated measurements pre- and post-analysis are recorded in
the system. Perhaps all temperatures will be recorded in Celsius to two decimal places. If temperature data imported
from a spreadsheet or a lab instrument is not in this format, the LIMS can normalize the incoming data to match the
standard already set for existing LIMS temperature data. This ensures consistency within the LIMS database and
typically leads to better data validation efforts later on.
Note: Some LIMS developers may include data normalization functionality within what they may refer to as data
validation functionality. The line between these two may be blurred or not exist at all.

Data validation
For the purposes of describing LIMS functionality, "data validation" specifically refers to the process of ensuring
existing data in the LIMS either pre-analysis or post-analysis sufficiently meets any number of standards or
thresholds set for sample login, sample analysis, or any other data management process in the LIMS. This validation
process may be completely automatic and system-based, or it may also include additional steps on the part of the
user base utilizing additional LIMS functionality, including verification of standard operating procedures (SOPs),
QC samples, and QA approval.
Note: This functionality shouldn't be confused with the process of validating the LIMS itself, which is an entirely
different process partially falling under regulatory compliance and involves the process of ensuring "the software is
performing in a manner for which it was designed."
LIMS feature 64

Data encryption
The existence of this functionality in LIMS software generally indicates the LIMS has the ability to protect the
integrity and authenticity of its housed data through the use of a variety of technologies which makes data
unreadable except to those possessing a key/right/etc. to unlock/read the data. This functionality is especially vital to
the Web-enabled LIMS, which transfers information over the Internet in a client-server relationship. As a wide
variety of encryption technologies exist, it's generally a good idea to consult with the developers of a LIMS to
determine the strengths and weaknesses of their employed encryption methods.

Version control
Version control is a form of safeguard which helps preserve data integrity. This is typically done by creating a
modifiable new version of a piece of information rather than allowing the original to be modified. Such versioning
may be applied to a wide variety of digital information housed in the LIMS, including test methods, training
certifications, instrument logs, specifications, and process and procedure (P&P) documentation. In LIMS like
LabWare LIMS, reference data can also be versioned while also retaining the original relationship between samples
and test results, including the version of reference data current at the time lab testing is performed. Information
tracked with such revisions includes attributes like user name, time the edit was made, and what exactly was edited.
This also benefits those managing audit trails and chains of custody.
Other LIMS may employ a different form of version control called file
locking, which simply puts the affected information into a read-only
mode for users while someone else is busy editing it. Another popular
strategy is to, rather than locking the file, allow multiple people edit to
a piece of information, later merging the various edits. Potential LIMS
buyers may need to inquire with developers to determine what type of
versioning scheme is used in the vendor's software.

The temperature of an open cryopreservation

Automatic data backup
container may be monitored on a computer via a
The existence of this piece of functionality in a LIMS usually means connection to a LIMS with environmental
monitoring functionality.
information contained in one or more associated databases or data
warehouses can be automatically preserved in an additional backup
file. The save location for that file as well as the scheduled backup time is configurable, typically through the
administrative module of the LIMS.

Environmental monitoring
Some LIMS like Core LIMS and Oracle Health Sciences LabPas allow users to monitor the environmental
conditions of not only sample storage containers but also the entire laboratory itself. Attributes like humidity, air
quality, and temperature may be monitored to ensure sample storage units and experiments maintain desired
conditions. Alarms may be able to be configured to notify staff if a storage container's environmental attributes go
beyond a certain threshold. Manufacturers utilizing a LIMS like NOVA-LIMS may also be able to employ more
advanced environmental tracking features in the plant to guarantee a more consistent, higher quality product is
created.
LIMS feature 65

Reporting, barcoding, and printing

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Custom reporting
Reporting is a vital part of a LIMS, as it allows users to gain a clearer picture of collected data and potential trends.
At a minimum a number of pre-configured report styles come standard with a LIMS. However, some LIMS are more
flexible than others, offering the ability to customize reports in numerous ways. The most popular attributes of
custom reporting include custom headers, custom information placement, charts, pivot tables, and multiple output
formats.
Note: Some LIMS vendors will offer custom reporting as an option as an added cost, depending on the level of
customization required.

Report printing
Today's LIMS software almost universally offers the ability to print reports and other materials, so this feature may
seem a bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of
LIMS software.

Label support
The label typically affixed to a sample container is a vital part of the sample tracking process. Identifying
information such as sample number, batch number, and barcodes are printed on such labels to ensure optimized
sample management and more precise sample data. As such, some LIMS allow users to design and print labels
directly from the software.

The word "Wikipedia" encoded in Code 128 and
Code 39
Barcode support
Barcodes offer many advantages to laboratory techs handling samples,
including more accurate data input, tighter sample/instrument
associations, tighter sample/study associations, and more room for
human-readable information on a label. Given such advantages, many
LIMS developers have integrated barcode support into their laboratory
information management systems, including support for symbologies
like Code 128, Code 39, and Interleaved 2 of 5. Aside from printing
options, a LIMS may also offer support for a variety of bar code
readers.
Barcode support and label support are typically found together in
LIMS software, but not always, thus their separation into two features
of a LIMS.
LIMS feature 66

Export to PDF
A LIMS with this feature is able to collect and save information into a Portable Document Format (PDF).

Export to MS Word
A LIMS with this feature is able to collect and save information into a Microsoft Office Word format.

Export to HTML or XML

A LIMS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and/or
Extensible Markup Language (XML) format.

Fax integration
A LIMS with this feature is able to connect with a fax machine and send information to it via manual input,
automatically, and/or at scheduled intervals.

Email integration
A LIMS with this feature is able to integrate with and use the electronic mail information exchange method to send
reports, alerts, and more via manual input, automatically, and/or at scheduled intervals.

Base functionality
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Administrator management
The administrator management tools of a LIMS allow lab technicians to set up the LIMS most optimally for the
laboratory. Through the administrator management interface of a LIMS, other features may be accessed like setting
up user roles and scheduling automatic data backups.
Like report printing, administrator management is nearly ubiquitous in LIMS software, generally considered a
mandatory feature. However, for the purposes of being thorough, it's important to point out its existence.
LIMS feature 67

Modular
This feature indicates that a LIMS has an intentional modular design, which separates some functionality into
manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured
addition of new functionality to a LIMS and 2. the limiting of overall effects on the system design as new
functionality is added.

Instrument interfacing and management

In laboratories there are instruments, and with those
instruments comes scientific measurements which
produce data. It's therefor natural a lab technician
would want to connect those instruments to a
laboratory information management system, which is
already organizing and storing laboratory data. This
sort of interfacing is typically handled with
instrument-to-LIMS interfaces, which started out as
merely data-transfer mechanisms. Later that interface
mechanism became much more robust as a data
management tool, though often at great expense with
heavy involvement from third parties. Today, "many
LIMS vendors can act as single source providers of An entire room of gas chromatography instruments could potentially be
the entire instrument interfacing solution,", providing connected to a LIMS via instrument interfacing.
a cheaper and smoother solution to LIMS customers.
The ability to calibrate and schedule maintenance for interfaced instruments may also be included in this category.

Mobile device integration

While not incredibly common, a few LIMS developers are including support for mobile devices in their laboratory
information management system. LabCollector, for example, extends its LIMS' functionality to Pocket PC or
Windows CE devices equipped with wireless barcode scanners, allowing users to read or collect sample information
while on the move. Future Technologies' DNA LIMS, designed for labs performing DNA analysis, has its own
mobile version for technicians who need access but can't be in the lab.

Alarms and/or alerts

Alarms and alerts are an integral part of a LIMS. They can be automatic or scheduled, and they can come in the form
of an e-mail, a pop-up message, or a mobile text message. When the results for a sample analysis go out out of range,
an automatic warning message can appear on the screen of the technician responsible for the analysis. A scheduled
alert can be e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine
maintenance. If the LIMS is equipped with environmental monitoring, an alert can be sent in the form of an SMS
text message to the head researcher if the temperature inside a freezer unexpectedly rises. All of these scenarios
represent a tiny fraction of the possible implementation of alarms and alerts in a LIMS, highlighting how powerful
(yet easy to take for granted) this feature is.
LIMS feature 68

Work-related time tracking

This feature specifically refers to a LIMS' ability to track the amount of time an employee spends at work in general
(for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program).

Voice recognition system

A LIMS with this feature allows some functions of the LIMS (for example, accessing sample analysis results) to be
accessed via voice commands.

External monitoring
This feature allows clients outside the laboratory to monitor the status of sample batches, test results, and more via
an online Web portal or, less commonly, as activity alerts sent via e-mail, fax, or SMS.

Messaging
The messaging feature of a LIMS may refer to one (or both) of two
things:
a built-in instant messaging system that allows users to converse
with each other through text messages real-time
an SMS text messaging integration that allows the users or the
LIMS itself to send messages or alerts to a user's mobile or smart
phone

Multilingual
If a LIMS is listed as multilingual, its an indication the LIMS interface
can be configured to display more than one language depending on the
preference a user or administrator chooses. Some LIMS interfaces can
only be displayed in one of two languages (English or German, for Instant messaging clients built into a LIMS often
example), while others come configured with support for dozens of make it easier to collaborate.

languages.

Network-capable
This feature is perhaps archaic and/or obvious, but it is mentioned nonetheless. It's generally applied to a
non-Web-based LIMS installed over a local or wide-area computer network, essentially indicating the LIMS is not
an isolated application, but rather one that can interface with other instances of the LIMS or other networked
instruments.

Web client or portal

A LIMS with a Web client or portal is either a Web-based LIMS (one that is not installed on every computer, but
rather is hosted on a server and accessed via a Web browser) or a non-Web-based LIMS with an included portal to
access it via the Internet.
LIMS feature 69

Online or integrated help

This indicates a LIMS has help infrastructure integrated into the software, support documentation via the LIMS
vendor's website, or both.

Software as a service delivery model

This indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model.

Usage-based cost
While rare, some LIMS vendors allow potential clients to license and utilize the vendor's software under a
usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost
directly related to the amount of samples processed each month.

References

Laboratory information system

A laboratory information system (LIS) is a software
system that records, manages, and stores data for
clinical laboratories. A LIS has traditionally been most
adept at sending laboratory test orders to lab
instruments, tracking those orders, and then recording
the results, typically to a searchable database. The
standard LIS has supported the operations of public
health institutions (like hospitals and clinics) and their
associated labs by managing and reporting critical data
concerning "the status of infection, immunology, and
care and treatment status of patients."

History of LIS
Advances in computational technology in the early
1960s led some to experiment with time and data
management functions in the healthcare setting.
Company Bolt Beranek Newman and the
Massachusetts General Hospital worked together to
create a system that "included time-sharing and
multiuser techniques that would later be essential to the
Hospitals and labs around the world depend on a laboratory
implementation of the modern LIS." At around the information system to manage and report patient data and test results.
same time General Electric announced plans to
program a hospital information system (HIS), though those plans eventually fell through.

Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of managing time
and data management functions wasn't heavily explored until the late 1960s, primarily because of the lack of proper
technology and of communication between providers and end-users. The development of the Massachusetts General
Hospital Utility Multi-Programming System (MUMPS) in the mid-'60s certainly helped as it suddenly allowed for a
Laboratory information system 70

multi-user interface and a hierarchical system for persistent storage of data. Yet due to its advanced nature,
fragmented use across multiple entities, and inherent difficulty in extracting and analyzing data from the database,
development of healthcare and laboratory systems on MUMPS was sporadic at best. By the 1980s, however, the
advent of Structured Query Language (SQL), relational database management systems (RDBMS), and Health Level
7 (HL7) allowed software developers to expand the functionality and interoperability of the LIS, including the
application of business analytics and business intelligence techniques to clinical data.
Today, web-based and database-centric Internet applications of laboratory informatics software have changed the
way researchers and technicians interact with data, with web-driven data formatting technologies like Extensible
Markup Language (XML) making LIS and EMR interoperability a much-needed reality. SaaS and cloud computing
technologies have further changed how the LIS is implemented, while at the same time raising new questions about
security and stability.

Common LIS functions

Functions that a LIS has historically performed include, but are not limited to:
patient management, including admission date, admitting physician, ordering department, specimen type, etc.
patient data tracking
decision support, including comparisons of lab orders with their respective ICD-9 codes
test ordering
quality assurance
workload and management reporting
workflow management
billing

Clinical vs. anatomic pathology LIS

The laboratory information system has been primarily segmented into two broad categories (though other variations
exist): the clinical pathology and anatomic pathology LIS.
In clinical pathology the chemical, hormonal, and biochemical components of body fluids are analyzed and
interpreted to determine if a disease is present, while anatomic pathology tends to focus on the analysis and
interpretation of a wide variety of tissue structures, from small slivers via biopsy to complete organs from a surgery
or autopsy. These differences may appear to be small, but the differentiation in laboratory workflow of these two
medical specialties has led to the creation of different functionalities within LISs. Specimen collection, receipt, and
tracking; work distribution; and report generation may vary sometimes significantly between the two types of
labs, requiring targeted functionality in the LIS. Other differences include:
Specific dictionary-driven tests are found in clinical pathology environments but not so much in anatomic
pathology environments.
Ordered anatomic pathology tests typically require more information than clinical pathology tests.
A single anatomic pathology order may be comprised of several tissues from several organs; clinical pathology
orders usually do not.
Anatomic pathology specimen collection may be a very procedural, multi-step processes, while clinical pathology
specimen collection is routinely more simple.
Laboratory information system 71

Differences between a LIS and LIMS

There is often confusion regarding the difference between a laboratory information system (LIS) and a laboratory
information management system (LIMS). While the two laboratory informatics components are related, their
purposes diverged early in their existences. Up until recently, LIMS and LIS have exhibited a few key differences:
1. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical
setting. A LIMS has traditionally been designed to process and report data related to batches of samples from drug
trials, water treatment facilities, and other entities that handle complex batches of data.
2. A LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, HIPAA, and other clinical
medical practitioners. A LIMS, however, needs to satisfy good manufacturing practice (GMP) and meet the
reporting and audit needs of the U.S. Food and Drug Administration and research scientists in many different
industries.
3. A LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and
clinical labs, whereas a LIMS is most competitive in group-centric settings (dealing with "batches" and "samples")
that often deal with mostly anonymous research-specific laboratory data.
However, as of 2011 these distinctions have faded somewhat as some LIMS vendors have adopted the case-centric
information management normally reserved for a LIS, blurring the lines between the two components further.

LIS vendors
See the LIS vendor page for a list of LIS vendors past and present.

Further reading
Henricks, Walter H. (09 October 2012). "LIS Basics: CP and AP LIS Design and Operations" [1] (PDF).
Pathology Informatics 2012. Walter H. Henricks, MD.
Park, Seung Lyung; Pantanowitz, Liron; Sharma, Guarav; Parwani, Anil Vasdev (March 2012). "Anatomic
Pathology Laboratory Information Systems: A Review" [2]. Advances in Anatomic Pathology 19 (2): 8196. doi
[2]
:10.1097/PAP.0b013e318248b787 [3]. (Alternate URL [4])

References
[1] http:/ / www. pathinformatics. pitt. edu/ sites/ default/ files/ 2012Powerpoints/ 01HenricksTues. pdf
[2] http:/ / ebookbrowse. com/ anatomic-pathology-laboratory-information-systems-a-review-slpark-et-all-adv-anat-pathol-2012-pdf-d344405134
[3] http:/ / dx. doi. org/ 10. 1097%2FPAP. 0b013e318248b787
[4] https:/ / docs. google. com/ gview?url=http:/ / bpa-pathology. com/ uploads/ file/ docs/ Anatomic+ Pathology+ Laboratory+ Information+
Systems+ -+ A+ Review+ -+ SLPark+ et+ all. + -+ Adv+ Anat+ Pathol+ 2012. pdf& chrome=true
LIS feature 72

LIS feature
You can find a listing of all LIS vendors and by extension, the features their products offer on the LIS vendor page.

A LIS feature is one or more pieces of

functionality that appear within a laboratory
information system (LIS).
The LIS has traditionally been utilized in
clinical, pathology, and medical research
laboratories as well as numerous public
health institutions. Yet as laboratory
demands have changed and technological
progress has continued, the functions of a
LIS have also changed, with the distinction
between a LIS and a laboratory information
management system (LIMS) fading as some
LIMS vendors have adopted the case-centric
information management normally reserved
Thousands of hospital laboratories like this one benefit from the use of a laboratory
for a LIS..
information system.
Despite the blurring of distinction between a
LIS and a LIMS, the LIS generally continues to feature the following:
patient management, including admission date, admitting physician, ordering department, specimen type, etc.
patient data tracking
decision support, including comparisons of lab orders with their respective ICD codes
quality assurance of ordered tests
workload and management reporting
Of course, there are LIS features that are difficult to categorize or simply contribute to the whole of the LIS rather
than add a function. For example, multilingual support allows users to interact with the LIS in more than one
language. Some functionality may also overlap several research phases, making it difficult to firmly classify.
The features described below come from an analysis of freely available LIS product information on vendor websites.
An attempt was made to discover the features most utilized in vendors' LIS products and collect information on those
features for each LIS. Not every possible feature is referenced here; some LIS products fill specific niches, utilizing
unique functionality to solve a specific problem.
That said, keep in mind the categorization of features below is very loose. It may be viable to argue a feature belongs
under a different section or multiple sections. For the purposes of organizing this information in an uncomplicated
manner, however, some liberty has been taken in the categorizing of features.
LIS feature 73

Experiment, patient, and data management

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Sample login and management

Sample login and management often referred to as accessioning or specimen management is an important
component of the clinical laboratory, whether it's a molecular pathology lab testing samples for disease indicators or
a contract lab running pharmacokinetic and biomarker analysis on samples from a clinical trial. As such, researchers
and technicians who work in these types of labs are unable to complete their tasks without an effective method of
managing samples. The process of sample management and accessioning includes, but is not limited to:
storing related sample information, including demographics, dates, and external links
creating and documenting viewable sample container schemas with name and status
assigning sample access rights
assigning custom sample ID or accessioning numbers based on a specification
applying additional processing to the sample before storage and/or analysis
Additional functionality that could potentially fall under this feature:
barcoding or RFID tagging of samples
defining sample points and series
creating data associations for samples - such as pedigree for sample/aliquot relationships or relationships based on
experiment, etc.
issuing sample receipts

Sample tracking
For most laboratory personnel, knowing that a sample has arrived to
the lab isn't good enough; they need to know where it's located and
what is being done with it. Enter the sample tracking feature. Without
it, many problems arise. In the forensic world, for example, many
samples are linked to a criminal investigation. In this case,
misidentification, contamination, or duplication can become significant
issues: a lost sample is essentially missing evidence, while a duplicated
sample can render it useless as evidence.
After sample reception and its initial handling procedures, many LIS
can then track sample location as well as chain of custody. Location
tracking usually involves assigning the sample to a particular freezer,
oven, or other location, often down to the granular level of shelf, rack,
box, row, and column. The process of tracking a sample has become
more streamlined with increasing support of 2-D barcode or
radio-frequency identification (RFID) technology. While handwritten
labels were the norm, now barcode and RDIF support in a LIS can "tie
together a vast amount of information, clearly relating each sample to a
Where's sample 20110512_122GJH? Sample
specific case." Other event tracking such as freeze and thaw cycles that tracking functionality will let you know which
a sample undergoes in the laboratory may also be required. As each lab oven it's in.
laboratory's needs for tracking additional data points can vary widely,
many modern LIMS and LIS have implemented extensive configurability to compensate for varying environments.

The functionality of sample tracking strongly ties into the audit trail and chain of custody features of a LIS.
LIS feature 74

Sample and result batching

What is batching? The United States Environmental Protection Agency (EPA) defines a batch as "a group of samples
which behave similarly with respect to the sampling or testing procedures being employed and which are processed
as a unit." This definition can be applied to many laboratories which handle large quantities of samples for some
form of analysis or processing. A LIS that has the ability to check in, link, and track groups of samples across one or
multiple facilities is valuable to such laboratories. Additionally, batching the analysis results of multiple samples or
groups of samples gives laboratories more flexibility with how they manage their data. Batching also offers the
benefit of mimicking the production groups of samples while also capturing quality control data for the entire group.

Task and event scheduling

Within the context of a LIS, the ability to schedule a task or event is a natural extension of how work was done in a
laboratory before the advent of data management systems. Sample processing, data analysis, equipment
maintenance, and case management follow-ups are assigned to technicians and other personnel. Outpatient
scheduling is another aspect of some clinical atmospheres, better handled with computerized scheduling
functionality. While these tasks have in the past been performed without the LIS, a modern data management system
can now optimize those tasks and provide additional scheduling functionality to streamline the operation of a lab.
Some LISs like Elekta AB's IntelliLab include a scheduling calendar for recurring test orders, rules-based orders, and
pre-defined selection lists. Additional functionality within this feature group includes the ability to configure
automated assignments of experiment requests, establish recurring events, and in most cases, create printable reports.
Examples of tasks and events that can feasibly be scheduled in a LIS include:
production of reports
creation and sending of e-mails and alerts
maintenance of equipment
assignment of accessioning tasks to technicians
scheduling outpatient visits

Option for manual result entry

While many LIS vendors tout the ability of their product to automate the entry of sample analysis results into LIS' or
other databases, the need for manual data entry of analysis results still exists. This feature is important to laboratories
obtaining analysis results from multiple sources, including non-digital paper-based results and instruments that can't
be connected to the LIS. Additional functionality associated with this feature includes a customizable spell-check
dictionary and the ability to add comments, notes, and narratives to many of the data items in the LIS.

Multiple data viewing methods

Hospitals, physicians, and clinical research facilities produce reams of data, and the LIS exists to help organize and
distribute that data to the necessary entities. Additionally, even before the existence of the LIS, scientists have had a
corresponding need for visually representing that data for clearer analysis and hypothesis creation. Today a LIS can
not only collect and analyze data, but it also can represent that data in reports, graphs, gradients, and spreadsheets.
Depending on the LIS, more than one way to visually represent the data may exist.
This category ties in with the custom templates and forms functionality apparent in some LIS, providing both custom
and standardized ways to present information across a healthcare or medical research enterprise.
LIS feature 75

Configurable templates and forms

Similar to an electronic laboratory notebook (ELN), a template in a LIS is a functionality item which allows users to
increase the productivity and quality of their work by allowing for the creation of a standardized analysis page,
patient page, or reporting process across a healthcare or medical research enterprise. These templates allow
researchers to maintain more consistent data representation for similar tasks in the LIS and save time by not needing
to manually input common data outputs or recreate experiments. Templates and forms typically utilize a wide field
library, and the data that is posted to those template fields can also be normalized to a specific standard. Types of
templates that may be created include those for renal and blood pressure analysis, patient demographics, test
ordering, and department-level reports.

Data and trend analysis

For public health centers and pharmaceutical
research centers alike, data analysis plays an
important role in their operations, helping clinicians
and researchers make better sense of their collected
data and reach valuable conclusions about them.
While this important phase of laboratory work has
Some LISs allow users to analyze patient test results or clinical research often been done externally from the LIS, it's now
data with built-in software tools. more common to see basic analysis tools being
included. Such tools allow raw data to be imported
directly to the LIS, which then can store, process, and display it in a shareable form. Vendors may include data
analysis functionality by simply including Microsoft Excel compatibility or providing advanced reporting tools, or
they may take a more advanced approach by programming and including their own custom data and trend analysis
tools in their informatics software. As sample analysis is increasingly an important part of most if not all
laboratories, such functionality which has often come in the form of a separate application or analysis device
will likely continue to merge into software like LIS, LIMS, and other laboratory informatics solutions.

Data and equipment sharing

Aside from data storage and sample registration, a modern LIS's major contribution to the laboratory is aiding in the
sharing of test results, reports, and patient data with other entities across the clinical and research enterprise. Rather
than pieces of information becoming misplaced or locked away in a physician's office or pathology lab, the LIS
makes it easier to test results and increase the efficiency of patient-doctor-lab collaboration in general. Yet data is
more than just test results; it also can come in the form of charts, reports, policy and procedure, and other documents.
Additionally, the need for controlling who has access to those types of data is also an important consideration. As
such, this feature is at least partially tied to other features like document management and configurable security.

Data mining
Data mining, in the field of computational science, involves "the process of discovering interesting and useful
patterns and relationships in large volumes of data" and includes three computational steps: model-learning, model
evaluation, and model usage. As informatics software allows both research and clinical laboratories to collect and
manage increasing quantities of data, a corresponding demand for tools capable of modeling that data is appearing.
For example, public health laboratories may wish to utilize data mining for statistical analysis and surveillance of
populations for specific diseases. LIMSs like LabWare LIMS and LISs like Orchard Harvest are examples of
laboratory informatics software which incorporate data mining and reporting tools.
LIS feature 76

Customizable fields and/or interface

As thorough as some user interface (UI) developers may be in adding relevant fields and interface options for end
users, there are at times options that are either omitted or unanticipated. This has traditionally required the end user
to contact the vendor and ask if the needed option(s) can be added in the next release. However, many modern LIS
vendors have responded instead by adding functionality that gives end users and/or LIS administrators more control
over the user interface.
Aspects of the LIS's user interface that are often customizable by the end user include:
report interface and display
patient profile display
project and experiment display
Note in many cases an interface may be customized through the use of templates and forms, and as such, this
functionality may be closely tied to the configurable templates and forms functionality.

Query capability
As was the case before the advent of databases and electronic data management solutions, today researchers must
search through test results, patient notes, and other types of data to better draw conclusions from experiments,
diagnose patient illnesses, and plan pharmaceutical research activities. Whereas this used to mean browsing through
laboratory notebooks, Excel spreadsheets, or Access databases, now powerful query tools exists within data
management tools like the LIS and ELN. A flexible search algorithm can be implemented to allow users to search a
dataset by patient name (full or partial) or by any accessioning number. Or more advanced query tools may be
implemented to collate and search across multiple datasets.
Query functionality often includes the ability to:
search both transactional data and archived data tables
search multiple databases via an application programming interface (API) or open database connectivity (ODBC)
connection
filter and sort data
collate queried data for further analysis and visualization
create ad-hoc queries

Import data
Data can originate from numerous places in the laboratory. The ability to import that data into a LIS can be
beneficial, especially when an instrument can't be connected or external clients collaborating on a project need to
submit relevant data. Of course instrument interfacing allows for even more importation options. Additional data
validation procedures may be applied to the imported data to guarantee information homogeneity. For the LIS, one
of the common sources of importing data is a separate electronic medical record (EMR) system, for collecting
patient data and test orders.
LIS feature 77

Internal file or data linking

This feature allows research collaborators
using a LIS to link together sample batches,
reports, protocols, results, and more,
providing greater contextual clarity to
projects and datasets. Examples include:
linking a sample batch to a test or sample
preparation methodology
linking a test process to a particular
experiment
linking a report to a sample batch
linking a group of experiment results to a
raw data file
linking multiple images to a patient
record
linking all experiment results with the
Many informatics systems allow for internal linking of data; however, entities
correct reporting test methods outside of the system often need to access the data housed within. A LIS is often
capable of such external data linking.
External file or data linking
This feature allows research collaborators using a LIS to link together data and files housed in the database with
data, files, and customers outside the LIS's domain. Examples include:
linking to an external practice management or electronic medical record (EMR) system using an an
HL7-compliant interface
linking one public health data source with others to pool demographic and medical information for better disease
modeling
linking to separate clinical trial laboratory data files within a report

ELN support or integration

The functionality of a LIMS and an ELN began to blur in the 2000s, with both types of software incorporating
features from the other. It has been more common to see a LIMS take on some sort of ELN support (or vice versa),
but less common in the LIS. Though uncommon, some LIS may include some sort of integration or compatibility
with an ELN, and thusly this functionality is at least mentioned.

Export to MS Excel
While Microsoft Excel has long been used within the laboratory setting, a slow shift towards relational databases and
LIMS occurred in the late 1990s and early 2000s. Additional concerns with the difficulties of Excel's validation and
compliance with FDA 21 CFR Part 11 and other regulations have led many labs to turn to data management
solutions that are easier to validate. Nevertheless, laboratories continue to use Excel in some fashion, and thus Excel
integration or data exportation in Excel format is a real need for LIS customers. LISs with this feature allow raw,
processed, or imported data to be exported in the Excel format for further analysis and dissemination elsewhere in
the LIS or externally from it.
LIS feature 78

Raw data management

While not described as a feature on most LIS vendor websites, a few indicate their product is capable of managing
(import, export, editing, etc.) data in its raw format for future analysis and dissemination.

Data warehouse
An LIS's data warehouse serves the important function of storing, extracting, and managing the data that
laboratories, physician offices, and other facilities produce for the purposes of analysis, reporting, and dissemination,
typically separate from the primary storage database. Data warehouses also offer the benefit of speeding up queries,
making queries and data mining more user-friendly, and smoothing out data gaps.

Project and/or task management

Project and task management within a LIS typically involves the scheduling of tasks to technicians and organizing
associated tasks into a more cohesive unit for better tracking and management. While the functionality of task and
event scheduling can also be found in project and task management, many LISs include functionality beyond
scheduling that warrants the addition of the project and/or task management feature. This functionality includes:
job allocation and rescheduling
instrument workload tracking
pending workload verification
project- and experiment-based workflow management
sample, batch, and document linking
work template sharing
recurring event management
See also: Patient and case management

Test, experiment, and/or trial management

Specimen or sample test management is a common component of a LIS, while experiment and research trial
management functionality is a component of some LISs, often limited to those that are designed to help manage
clinical trials. Test, experiment, and trial management can cover a wide variety of tasks, from setting up the design of
a clinical trial to specimen task assignments, from ordering tests for patients to planning trial experiments. Note: this
may also be referred to as "order management" with some vendors.
It's worth noting this functionality category may seem broad in scope and include other functionality listed on this
page, including workflow management and project and task management. Its inclusion when reviewing software
functionality is primarily to indicate when a vendor or project team indicates the existence of specific test,
experiment, or trial management tools in their software.

Inventory management
Laboratories use a wide array of inventory, from reagents to glassware, from radiopharmaceuticals to laboratory
baths. With that comes the need to know how much/many and the frequency of use. For this, some LIS products
(especially those for pathology labs) now offer limited or full-featured inventory management functionality, which
may include the ability to:
register the origin and demographics of incoming materials.
track used and in-use items via barcodes or RFID tags.
track inventory reduction based on usage and shipping out of the lab.
create alerts for when items reach a certain stock level.
calculate inventory cost and fluctuation.
LIS feature 79

manage transportation and routing.

manual incrementing/decrementing of items.
track location and usage of laboratory equipment.
track location and usage of reagents.
assign storage locations.
track forensic evidence.
It should be noted electronic equipment may also be considered inventory, and thus there is likely some functionality
crossover with instrument management features.

Document and/or image management

Standard operation procedures, (SOPs),
specifications, reports, graphs, images,
and receipts are all collected and used
in the average laboratory. With a LIS
already designed to reference and store
test and patient data of all types, it
makes sense to include functionality to
create, import, export, and manage
other sorts of data files. As
experimental data can be indexed,
queried, and linked, so too can
document data. Functionality of a
typical document management system
includes the ability to:
upload and index documents.
add images and photos inline to a
Standard operating procedures, workflow diagrams, and business models can all be
patient or case entry.
handled effectively with document management functionality.
enforce version control.
provide full text searches.
export to PDF, XML, or other relevant formats.
add documents as attachments.

Patient and case management

The laboratory information system (LIS) has played an important role in the case management tasks of
patient-centric and clinical laboratories. LIS products have included patient or case management tools suitable for
the clinical, public health, and veterinary industries, as well as the fields of law enforcement and forensic science.
Functionality seen in the patient and case management feature includes:
case accessioning and assignment
disease tracking
trend analysis
clinical history follow-up
out-of-range result alerts
document and result association
evidence control
study management
collating of patient data across multiple spectrum
LIS feature 80

Workflow management
Workflow management is common in the laboratory, acting as a
graphical representation of planned sequential steps to either automate
or clarify a process or experiment within the lab. Separate
standards-based workflow management systems (in the form of a
software component) have traditionally performed this task. However,
in the 2000s vendors began incorporating workflow management
functionality into their laboratory informatics software, reducing
customization headaches in the process.

Modern commercial and open-source LIS solutions recognize clinical

Capturing workflow in the lab is becoming more
commonplace for laboratory informatics
products.
laboratory workflow often has its own share of requirements, requiring
specific workflow management functionality, including:
managing the request cycle within a laboratory

organizing and executing diagnostic testing

managing specific chemistry- and biology-related procedures
defining activity attributes
managing automation tools to better workflows
re-route samples based on changes to a process
dynamically modifying workflow in case of future changes
receiving notification of changes to the workflow

Specification management
Specification (spec) management is vital to not only the manufacturing and research industries but also to a host of
other laboratories requiring precise measurements and infallible test methods. Just as the ASTM offers standards and
specs for laboratory informatics software, so too do users have standards and specs for their laboratory.
Spec management has primarily been seen in a manufacturing execution system (MES) or a LIMS, but occasionally
a LIS may appear which includes such functionality. With spec management in place, laboratories can then:
enforce standard operating procedures and business rules.
create specs down to a project or sample level.
validate recipes and procedures.
accept or reject sample batches.
document internal and external spec history.
Note some of the functionality of spec management may cross over into the realm of quality control and data
validation.

Customer, supplier, and physician management

Unless a laboratory is conducting internalized independent research, in most cases it will do business with external
entities such as contract labs, physician offices, equipment providers, and reagent suppliers. In some cases, even
internal employees may be considered a customer, necessitating documentation of who is using the system and in
what ways. For a veterinary lab, the customer may be the animal and handler. For a forensic lab the customer may be
more complex: internal staff, university staff, police departments, and maintainers of nationwide crime databases
may all at some point act as customers. In these cases, documenting these various points of contact and linking them
to tests, equipment, and patients becomes vital. Managing demographics, complaints, correspondence, and history
are all feasible with customer, supplier, and physician management functionality. This process is often made simpler
LIS feature 81

through the use of a more context-neutral entity creation system, which allows for more flexible management of
contacts.
This feature may also be referred to as contact management, an address book module, or a customer service module.

Billing and revenue management

While the finances of a laboratory are important, they've typically been handled separately as a business process.
However, some LISs include additional functionality to make handling financial transactions and documentation of
all sorts possible within the LIS. In theory, such functionality brings the possibility of keeping more of a laboratory's
data centrally located and queryable. This feature may include:
payment processing
expense reporting
price quotes
revenue management
workload tracking of billable hours
bill of materials
sales team and client management
profitability analysis
medical necessity checks

Quality, security, and compliance

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Regulatory compliance
The topic of whether or not a LIS meets regulatory compliance is often a complex one. While Title 21 CFR Part 11
has arguably had the largest influence on an electronic data management system's compliance, other influential
standards have shaped the way laboratory informatics systems handle and store data. Other compliance-based codes,
standards, and regulations include:
ASTM
ASCLD/LAB
Classified data
Freedom of information legislation (various)
GALP and GAMP
HIPAA
Health Level 7
ICD
ISO/IEC 17025
ISO 9000/9001
ISO/TS 16949
ODBC
TNI and NELAP
Title 40 CFR Part 3
With so many codes, standards, and regulations, LIS consumers are advised to contact vendors with their user
requirements and ask how the vendor's software meets and/or exceeds those requirements.
LIS feature 82

QA/QC functions
The quality management functions of a LIS allow users to maintain a level of necessary quality across many of the
functions in a laboratory. Some of the activities quality assurance / quality control functionality allows for includes:
force random review of cases by second pathologist before case verification
receive and process QC results from laboratory analyzers
create user rules
set up custom alerts and flags for out-of-range results
observe standard deviations in outcome research
review and sign off on data electronically
delta checking

Performance evaluation
As document and file management plays an important role in clinical and research laboratories, it only makes sense
to collate and store all the associated data for future reference, including documentation relating to individual
training and performance. Changes to laboratory techniques, scientific understanding, and business practices force
lab technicians and researchers to learn, reevaluate, and demonstrate competency in order to maintain quality levels
in the laboratory. Evaluations can frequently extend beyond staff members, however. Clinics, visit types, vendors, or
test species can also be tracked and evaluated based on custom criteria. The performance evaluation functionality of
a LIS makes this possible.
That functionality typically includes the ability to maintain training records and history, and also to link that training
to a technique or piece of equipment. Afterwards, the staff member, vendor, etc. can be marked as competent or
certified in the equipment, knowledge, or process. Periodical assessment of the training and its practical
effectiveness can later be performed. Productivity of an entity or process can also be gauged over a certain date range
based on tracked time, pre-determined milestones, or some other criteria.

Audit trail
As codes and regulations like Title 21 CFR Part
11 mandate "computer systems (including
hardware and software), controls, and attendant
documentation" utilize electronic signatures and
audit trails, LIS developers must put serious
thought into how their software handles audit
trail functionality. The audit trail
documentation of the sequence of activities that
have affected an action must be thorough and
seamlessly integrated into the software.

Information recorded in the audit trail typically

includes:
Whether validating an instrument's data or an entire LIS, maintaining an audit operator code
trail is an important part of 21 CFR Part 11 compliance. time stamp
location
case number
accessioning number
transaction type
amount and quantity prior to change
LIS feature 83

user notes

Chain of custody
The chain of custody (COC) of an item is of varying importance, depending on the type of laboratory. A highly
regulated laboratory that works under Code of Federal Regulation or other guidelines makes tracking COC a vital
part of its operations. This is especially true in forensic labs, which depend on continuous accountability of their
evidence collection, retention, and disposal procedures. As with an audit trail, a laboratory depends on recorded
information like user ID, time stamp, and location ID to maintain a robust and accurate COC. Barcodes and RFID
tags, inventory management, and configurable security roles all play an important part in maintaining chain of
custody.

Configurable roles and security

Many roles exist within the clinical and research setting, each with its own set of responsibilities. And just as the role
an individual plays within the laboratory may change, so may the responsibilities associated with each role. This sort
of change necessitates a flexible and configurable security system, one that allows for the placement of individual
LIS users into standardized security roles which provide role-specific access to certain functionality. Additionally, as
responsibilities change within roles, that same flexible configuration is necessary for assigning or restricting access
to specific functionality for each existing or newly created role.
Of course, roles aren't always assigned on an individual level. Often large groups of individuals may need to be
assigned to roles, necessitating group assignments for security purposes. For example, a group of hospital laboratory
trainees may not be given access to the inventory management functionality of the system through a custom
"Trainees" group role, while the head of the lab may be given the "Administrator" role, which allows that individual
to access a much broader spectrum of the LIS's functionality.

Data normalization
For the purposes of describing LIS functionality, "data normalization" specifically refers to the process of ensuring
incoming/imported data into the LIS is standardized to the same format of existing data.
Here's an example to better explain this issue. When a LIS is initially configured, in most if not all cases a clear
standard can be set for how logged test results and their associated measurements pre- and post-analysis are recorded
in the system. Perhaps all temperatures will be recorded in Celsius to three decimal places. If temperature data
imported from a spreadsheet or a lab instrument is not in this format, the LIS can normalize the incoming data to
match the standard already set for existing temperature data. This ensures consistency within the database and
typically leads to better data validation efforts later on.
Note: Some LIS developers may include data normalization functionality within what they may refer to as data
validation functionality. The line between these two may be blurred or not exist at all.
LIS feature 84

Data validation
For the purposes of describing LIS
functionality, "data validation" specifically
refers to the process of ensuring existing
data in the LIS either pre-analysis or
post-analysis sufficiently meets any
number of standards or thresholds set for
any given data management process. This
validation process may be completely
automatic and system-based, or it may also
include additional steps on the part of the
user base utilizing additional LIS
functionality, including verification of
standard operating procedures (SOPs), QC
samples, and QA approval.

Note: This functionality shouldn't be

confused with the process of validating the
application itself, which is an entirely
different process partially falling under
regulatory compliance and involves the In a LIS, data and data models can be forced through a validation process to
remove errors and reconcile that those data and models.
process of ensuring "the software is
performing in a manner for which it was
designed."

Data encryption
The existence of this functionality in a LIS indicates the software has the ability to protect the integrity and
authenticity of its housed data through the use of a variety of technologies which makes data unreadable except to
those possessing a key/right/etc. to unlock/read the data. This functionality is especially vital to the web-enabled LIS,
which transfers information over the Internet in a client-server relationship. As a wide variety of encryption
technologies exist, it's generally a good idea to consult with the developers of a LIS to determine the strengths and
weaknesses of their employed encryption methods.

Version control
Version control is a form of safeguard which helps preserve data integrity and thus ties in with the topic of
regulatory compliance. This is typically done by creating a modifiable new version of a piece of information rather
than allowing the original to be modified. Such versioning may be applied to a wide variety of digital information
housed in the LIS, including templates, training certifications, instrument logs, specifications, and process and
procedure (P&P) documentation. Information tracked with such revisions includes attributes like user name, time the
edit was made, and what exactly was edited. This also benefits those managing audit trails and chains of custody.
Other LIS vendors may employ a different form of version control called file locking, which simply puts the affected
information into a read-only mode for users while someone else is busy editing it. Another popular strategy is to,
rather than locking the file, allow multiple people to edit a piece of information, later merging the various edits.
Potential LIS buyers may need to inquire with developers to determine what type of versioning scheme is used in the
vendor's software.
LIS feature 85

Automatic data backup

The existence of this piece of functionality in a LIS usually means information contained in one or more associated
databases or data warehouses can be automatically preserved in an additional backup file. The save location for that
file as well as the scheduled backup time is configurable, typically through the administrative module of the
software.

Environmental monitoring
While not common at all, a few LIS may allow users to monitor the environmental conditions of not only sample
storage containers but also the entire laboratory itself. Attributes like humidity, air quality, and temperature may be
monitored to ensure sample storage units and experiments maintain desired conditions. This monitoring may be done
by treating the storage container as a device, which must be interfaced with the LIS. Alarms may be able to be
configured to notify staff if a storage container's environmental attributes go beyond a certain threshold.

Reporting, barcoding, and printing

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Custom reporting
Reporting often provides useful information representation for gaining a clearer picture of collected data and
potential trends. At a minimum, a number of pre-configured report templates typically come standard with a LIS.
However, other systems are more flexible than others, offering the ability to customize reports in numerous ways.
The most popular attributes of custom reporting include custom headers, custom information placement, charts, pivot
tables, and multiple output formats.
Note: Some LIS vendors may offer custom reporting as an option as an added cost, depending on the level of
customization required.

Synoptic reporting
Synoptic reporting is a specific type of reporting applicable to pathology and other associated laboratories. Synoptic
reporting essentially involves a structured, pre-formatted "checklist" of clinically and morphologically relevant data
elements (ideally passed to a relational database where they are efficiently organized, searched, and retrieved), with
the intent of making reporting more efficient, uniform, and relevant to internal and external researchers. This style of
reporting has the advantage of obviating the need for transcription services, reducing specimen turnaround time, and
prioritizing the presentation of large amounts of diagnostic information. Some LISs, especially those oriented
towards pathology, may include this specialized functionality. In some cases, a configurable templates or form may
be utilized to structure a report in a synoptic format, providing similar functionality to a separate synoptic reporting
module.
LIS feature 86

Report printing
Today's software almost universally offers the ability to print reports and other materials, so this feature may seem a
bit redundant to list. Nonetheless, printer support is a feature worth confirming when considering a piece of
laboratory informatics software.

Label support
The label typically affixed to a sample container or piece of equipment is a vital part of many laboratory
operations. Identifying information such as sample number, batch number, and barcodes are printed on such labels to
ensure optimize managing the location of items in a lab. As such, numerous LISs allow users to design and print
labels directly from the software.

Barcode and/or RFID support

The word "Wikipedia" encoded in Code 128 and
Code 39
Barcodes offer many advantages to laboratory techs handling samples,
including more accurate data input, tighter sample/instrument
associations, tighter sample/study associations, and more room for
human-readable information on a label. Given such advantages, many
laboratory informatics developers have integrated barcode support into
their software, including support for symbologies like Code 128, Code
39, and Interleaved 2 of 5. Aside from printing options, a LISmay also
offer support for a variety of barcode readers.
Additionally, some LIS include the ability to handle radio-frequency
identification (RFID) tags, which have several advantages over a more
traditional label-based approach to accessioning.

Barcode support and label support are typically found together in LIS software, but not always, thus their separation
into two features.

Export to PDF
A LIS with this feature is able to collect and save information into a Portable Document Format (PDF).

Export to MS Word
A LIS with this feature is able to collect and save information into a Microsoft Office Word format.

Export to HTML or XML

A LIS with this feature is able to collect and save information into a HyperText Markup Language (HTML) and/or
Extensible Markup Language (XML) format.

Fax integration
A LIS with this feature is able to connect with a fax machine and send information to it via manual input,
automatically, and/or at scheduled intervals.
LIS feature 87

Email integration
A LIS with this feature is able to integrate with and use the electronic mail information exchange method to send
reports, alerts, and more manually, automatically, and/or at scheduled intervals.

Base functionality
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Administrator management
The administrator management tools of a LIS allows researchers to set up the software most optimally for the facility
and its projects. Through the administrator management interface, other features may be accessed like setting up user
roles and scheduling automatic data backups.
Like report printing, administrator management is nearly ubiquitous in laboratory informatics software, generally
considered a mandatory feature. However, for the purposes of being thorough, it's important to point out its
existence.

Modular
This feature indicates that a LIS has an intentional modular design, which separates some functionality into
manageable components of the overall system. Generally speaking, a modular design allows for 1. the structured
addition of new functionality to a LIS and 2. the limiting of overall effects on the system design as new functionality
is added.

Instrument interfacing and management

In laboratories there are instruments, and with those instruments comes scientific measurements which produce data.
It's therefor natural a researcher would want to connect those instruments to a laboratory information system, which
is already organizing and storing laboratory data for hospitals and medical research facilities. This sort of interfacing
is typically handled with instrument-to-software interfaces, which started out as merely data-transfer mechanisms.
Later that interface mechanism became much more robust as a data management tool, though often at great expense
with heavy involvement from third parties. Today, "vendors can act as single source providers of the entire
instrument interfacing solution,", providing a cheaper and smoother solution to laboratory informatics customers. In
the clinical laboratory setting, a LIS vendor may have additional considerations to make, such as Health Level 7
(HL7) triggers, messages, and segments transported across communication interfaces.

Mobile device integration

In some cases mobile devices like these may
access and utilize a LIS, typically through a Web
portal or special mobile version of the software.
While not ubiquitous by any means, LIS developers are increasingly
including support for mobile devices in their software, usually in the
form of a separate mobile version of the software. Research and
development labs, for example, potentially can put mobile technology
to use in the laboratory as remotely monitoring a lab or using mobile
phone microscopy. Those uses aside, the relatively simple action of
recording and reviewing laboratory research results while on the move
or at a conference gives researchers flexibility, and LIS developers like
McKesson are beginning to include that functionality.
LIS feature 88

Third-party software integration

A few LIS vendors either incorporate third-party software into their product or they provide the means to integrate
the LIS with other applications. The most typical integration involves simply communicating with common
authoring tools like Microsoft Word, allowing users to work directly from the third-party application and then
transferring the information to the LIS.

Alarms and/or alerts

Alarms and alerts in a LIS can be automatic or scheduled, and they can come in the form of an e-mail, a pop-up
message, or a mobile text message. For example, when a test result goes out-of-range, an automatic warning message
can appear on the screen of the lab analyst responsible for the test. Another example: a scheduled alert can be
e-mailed to a lab technician every month indicating a piece of laboratory equipment needs routine maintenance. Both
scenarios represent a tiny fraction of the possible implementation of alarms and alerts in a LIS, highlighting how
powerful (yet easy to take for granted) this feature is.

Work-related time tracking

This feature specifically refers to a LIS' ability to track the amount of time an employee spends at work in general
(for payroll purposes) or on more specific projects and tasks (as part of an employee work evaluation program). May
also be referred to as "workload tracking" or "workload tracking."

Voice recognition system

A LIS with this feature allows some functions of the software (for example, accessing test results) to be accessed via
voice commands.

External monitoring
This feature allows clients and/or collaborators outside the laboratory to monitor the status of experiments, test
results, and more via an online web portal or, less commonly, as activity alerts sent via e-mail or SMS.

Messaging
The messaging feature of a LIS may refer to one of two (or both)
things:
a built-in instant messaging system that allows users to converse
with each other through text messages real-time
an SMS text messaging integration that allows the users or the LIS
itself to send messages or alerts to one or more user's mobile or
smart phone

An instant messaging client built into a LIS often
makes it easier to collaborate.
Commenting
Clinical data collection and research collaboration require data sharing
and communication tools to be most effective. One of the collaborative
communication features of some LISs is commenting on test results,
patient records, or study protocols.
LIS feature 89

Multilingual
If a LIS is listed as multilingual, its an indication the software interface can be configured to display more than one
language depending on the preference a user or administrator chooses. Some LIS interfaces can only be displayed in
one of two languages (English or German, for example), while others come configured with support for dozens of
languages.

Network-capable
This feature is perhaps archaic and/or obvious, but it is mentioned nonetheless. It's generally applied to a
non-web-based LIS installed over a local or wide-area computer network, essentially indicating the LIS is not an
isolated application, but rather one that can interface with other instances or other networked instruments.

Web client or portal

A LIS with a web client or portal is either a web-based LIS (one that is not installed on every computer, but rather is
hosted on a server and accessed via a web browser) or a non-web-based LIS with an included portal to access it via
the Internet.

Online or integrated help

This indicates a LIS has help infrastructure integrated into the software, support documentation via the vendor's
website, or both.

Software as a service delivery model

This indicates the software can be licensed and utilized via the software as a service (SaaS) delivery model.

Usage-based cost
While rare, some software vendors allow potential clients to license and utilize the vendor's software under a
usage-based cost model. An example of this model in use is Bytewize AB's O3 LimsXpress, which has a cost
directly related to the amount of samples processed each month.

References
 90

5. More Laboratory Informatics

Applications

Chromatography data management system

Sometimes referred to as a chromatography data
system (CDS), a chromatography data
management system (CDMS) is a set of dedicated
data-collection tools that interface and/or integrate
with a laboratory's chromatography equipment. A
base CDMS will set up a desired methodology to be
used by the chromatography equipment, acquire data
from it, process the acquired data, store the
information in a database, and interface with other
laboratory informatics systems to import and export
A liquid chromatography linear ion trap instrument as an example of a
files and data.[1]
device that may be interfaced with a CDMS

History of the CDMS

The first attempts to automate the analysis of chromatography data through electronics took place in the early 1970s.
These analysis tools utilized microprocessor-based integrators, "dedicated devices for measuring chromatographic
peaks and performing user-specified calculations" which also featured a printer plotter to output the results. Limited
memory plagued those early systems, preventing more than one chromatograph from being stored at any one time.
This became less of problem for large labs with bigger budgets in the mid-70s, as expensive centralized data systems
were installed, allowing greater data storage and sharing capabilities.
As computers shrank in size, the personal computer became a viable reality. In 1980 entrepreneur and
Hewlett-Packard prodigy Dave Nelson saw the potential the personal computer could have on the field of analytical
chemistry, joining with partner Harmon Brown to create Nelson Analytical Inc. That year they developed the first
CDMS personal computer software, soon followed by Turbochrom, the first CDMS system for MS Windows. This
innovation quickly spread from analytical chemistry labs to the fields of environmental, forensic, and pharmaceutical
sciences. At the same time chromatography minicomputers like Hewlett-Packard's 3350 LAS Lab Automation
System and Perkin-Elmer's LIMS 2000 CLAS chromatography laboratory automation system were seeing increased
utilization, featuring the data acquisition and processing of up to 32 or more simultaneous chromatographs.
In the 1990s, more affordable higher-performance PCs combined with tighter networking standards allowed
for networks of CDMSs, especially those installed on personal computers. By the late '90s, the CDMS commonly
featured the ability to set up a methodology and analytical run information, control some instruments, acquire
injection data, process the data in different ways, save the data, and transmit it to other systems like a LIMS. By
2008, CDMS functions were becoming more enhanced, driven by improvements in liquid chromatographs (LC) and
gas chromatographs (GC). The new innovation of high-speed LC and GC instruments meant the potential for faster
data generation, improved seperation, and higher resolutions and sensitivities. While these next-generation machines
would bring more processing power to chromatography labs, it also meant that vendors would have to improve
Chromatography data management system 91

CDMSs, specifically the analog-to-digital converter sampling rates. Some vendors were estimating at the time that
data acquisition sampling rates on the order of 100 to 300 Hz would be needed to keep up with the new wave of
speedier chromatography devices. Additional concerns of scalability and remote access were becoming important
due to the expansion of pharmaceutical and chemical companies expanding into parts of Latin America, South
America, and the Far East.

CDMS vendors
See the CDMS vendor page for a list of CDMS vendors past and present.

References
[1] McDowall, R.D. (1999). "Chromatography Data Systems I: The Fundamentals" (http:/ / www. 21cfrpart11. com/ files/ library/ compliance/
cds_1. pdf) (PDF), pp. 1-2.

Electronic laboratory notebook

An electronic laboratory notebook (also
known as electronic lab notebook or ELN) is a
software program or package designed to replace
more traditional paper laboratory notebooks.
Laboratory notebooks in general are used by
scientists and technicians to document, store,
retrieve, and share fully electronic laboratory
records in ways that meet all legal, regulatory,
technical and scientific requirements. A
laboratory notebook is often maintained to be a
legal document and may be used in a court of
Alexander Graham Bell's unpublished lab notebook, well before the invention
law as evidence. Similar to an inventor's
of the ELN
notebook, the lab notebook is also often referred
to in patent prosecution and intellectual property
litigation. Modern electronic lab notebooks have the advantage of being easier to search upon, support collaboration
amongst many users, and can be made more secure than their paper counterparts.

History of the ELN

While some credit Dr. Keith Caserta with the concept of an electronic version of the laboratory notebook, it's likely
that others had similar early ideas on how to integrate computing into the process of laboratory note taking.
Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format
was already in full swing in the early 1990s. During the 206th National Meeting of the American Chemical Society
in August, 1993, an entire day of the conference was dedicated to talking about "electronic notebooks" and ELNs. "A
tetherless electronic equivalent of the paper notebook would be welcomed by the working scientist," noted Virginia
Polytechnic Institute's Dr. Raymond E. Dessy for the conference. Dessy had in the mid-1980s begun postulating on
the idea of an electronic notebook, and by 1994 he provided one of the first working examples of an ELN.
By 1997, a special interest group called the Collaborative Electronic Notebook Systems Association (CENSA)
formed. Supported by 11 major pharmaceutical and chemical companies, the consortium worked with scientific
software and hardware vendors to facilitate the creation of an ELN that met the technical and regulatory needs of its
Electronic laboratory notebook 92

members. The consortium at that time envisioned a collaborative ELN that "teams of scientists worldwide can use to
reliably capture, manage, securely share, and permanently archive and retrieve all common data and records
generated by research and development and testing labs." That same year development of an enterprise-wide ELN at
Kodak's research facilities in England was in full swing. The Kodak ELN was "implemented as a collection of Lotus
Notes databases and applications," making it arguably one of the first enterprise ELN solutions in use at the time.
In 1998 one of the first web-based versions of an ELN was introduced in the form of the University of Oregon's
Virtual Notebook Environment (ViNE), "a platform-independent, web-based interface designed to support a range of
scientific activities across distributed, heterogeneous computing platforms." This innovation would go on to inspire
vendors in the 2000s to develop web-based thin-client ELNs for laboratories everywhere. Yet it likely wasn't until
the Electronic Signatures in Global and National Commerce Act (ESIGN) in June 2000 that the true legal
implications of a fully electronic laboratory notebook would have on the industry. If an ELN were to be responsible
for providing validation during the patent processes and be valid for other types of audits, a mechanism for
authenticating the origin of the ideas would be necessary. The ESIGN act meant that electronic records could be
authenticated and digital signatures made legally binding, lending further relevancy to ELNs. Instead of searching
through notebooks and piles of documents, printing material, and submitting thousands of pages for an FDA audit,
ELN users could suddenly collate and submit electronic records, saving time and headaches.
Enthusiasm for ELNs began to pick up again in the early 2000s, with a strong case for further data integration into
ELNs being made at the CENSA-supported International Quality & Productivity Center (IQPC) conference in
London during September 2004. During that conference the push for stronger data integration was made, with the
base premise that "ELNs would improve corporate strategy by allowing information to be used more intelligently
with the help of decision-support software." By early 2007, industry-specific ELNs were pushing growth in the
market: Scientific Computing World estimated 83 percent of related organizations declaring interest in ELNs, with
43 percent of those organizations seriously considering an evaluation or purchase.
Despite the beginnings of an economic downturn in the late 2000s, Atrium Research later estimated that ELN's
market potential was around $1.7 billion. During this time scientists and academics traditionally slow to adopt
technological change were gradually warming up to the benefits of an electronic laboratory notebook. Academics
in particular realized the problems the high turnover postdoc rate created in research laboratories. Postodocs would
depart from the university, leaving PIs and directors scratching their heads on where the data ended up. ELNs
changed that, allowing much more persistent data that can be found and referenced even after a postdoc departs.
The movement towards ELN integration into other laboratory functions during the 2000s eventually led to the
blurring of what an ELN actually is. In early 2007 Scientific Computing World reported that the definition of an
ELN varied among scientists, with 35 percent of them stating they were "clear about the difference between a LIMS
and an ELN." Today it's possible to see in some vendors' offerings the formerly distinct entity that was ELN to now
be completely integrated into a LIMS.

Regulations and legal aspects

The laboratory accreditation criteria found in the ISO 17025 standard needs to be considered for the protection and
computer backup of electronic records[citation needed]. These criteria can be found specifically in clause 4.13.1.4 of the
standard.
Electronic lab notebooks used for development or research in regulated industries, such as medical devices or
pharmaceuticals, are expected to comply with U.S. Food and Drug Administration (FDA) regulations related to
software validation. The purpose of the regulations is to ensure the integrity of the entries in terms of time,
authorship, and content. Unlike ELNs for patent protection, the FDA is not concerned with patent interference
proceedings, but rather with avoidance of falsification.
Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et
seq.) and 21 CFR 11. Essentially, the requirements are that the software has been designed and implemented to be
Electronic laboratory notebook 93

suitable for its intended purposes. Evidence to show that this is the case is often provided by a software requirements
specification (SRS) that lays out the intended uses and needs that the ELN will meet. The SRS typically includes one
or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification
and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized
changes without substantial collusion of otherwise independent personnel (i.e. those having no interest in the content
of the ELN such as independent quality unit personnel) are all fundamental to the ELN. Finally, one or more reports
demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of
the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then
corrective and preventive action (CAPA) must be undertaken and documented. Such CAPA may extend to minor
software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well.

Modern features of an ELN

ELNs are generally divided into two categories:
A "specific" ELN contains features designed to work within specific applications, scientific instrumentation, or
data types.
A cross-disciplinary or "generic" ELN is designed to support access to all data and information that needs to be
recorded in a lab notebook.
Among these two general categories are ELNs that capture two particular markets: individual researchers and group
research teams. ELNs can be tailored to one or both types of markets, with both groups and individuals benefiting
from the ELN's inherent ability to add structure to research records. Groups utilizing an ELN typically require two
additional abilities: to share research data and communicate about their research.
Modern features include, but are not limited to:
importation of data which has already been captured elsewhere
direct recording of data in various forms like text, images, and tables
lending of structure to data and information through the use of preformatted or customizable templates which
include a range of field types
creation of links between records
storage of fully searchable records in a secure database format
inclusion of a messaging system for better collaboration
a secure yet flexible environment to protect the integrity of both data and process while allowing for process
changes
generation of secure forms that accept laboratory data input via a computing device and/or laboratory equipment
accommodation for networked or wireless communications
a scheduling option for routine procedures such as equipment qualification and study-related timelines
configurable qualification requirements
Electronic laboratory notebook 94

ELN vendors
See the ELN vendor page for a list of ELN vendors past and present.

Further reading
LabCompliance News [1]
Taylor, Keith T. (2006). "The status of electronic laboratory notebooks for chemistry and biology" [2] (PDF).
Current Opinion in Drug Discovery & Development 9 (3): 348353. Retrieved 06 May 2011.

References
[1] http:/ / www. labcompliance. com/
[2] http:/ / www. symyx. com/ products/ pdfs/ Electronic_laboratory_notebooks. pdf

Laboratory execution system

A laboratory execution system or LES is a "computer system employed in the laboratory at the analyst work level
to aid in step enforcement for laboratory test method execution," according to the 2007 Annual Book of ASTM
Standards. The general purpose of the LES is to direct the user to follow specific steps to ensure the rigidity of the
test method and and the process' end results, though alternate workflow routes may be applied in specific
circumstances. The LES may encompass this functionality and more, including tasks like enforcing standard
operating procedures (SOPs), validating calculations and instrument interfaces, and acquiring or importing
procedural data from other systems into one common system.
For some, an LES may be considered a sub-branch of an electronic laboratory notebook (ELN) specifically made for
laboratories engaging in quality control and quality assurance applications, while others may consider it simply a
separate set of functionality which may be found in an ELN or a LIMS. Some in the industry suggest the term
"laboratory execution system" is a vendor-led morphing of the "method execution system," which was originally
designed "to address the problem of standard operating procedure (SOP) compliance."
In France, the English word "Middleware" is used to define a LES.

References
Scientific data management system 95

Scientific data management system

A scientific data management system (SDMS) is a piece or package
of software that acts as a document management system (DMS),
capturing, cataloging, and archiving data generated by laboratory
instruments (HPLC, mass spectrometry) and applications (LIMS,
analytical applications, electronic laboratory notebooks) in a compliant
manner. The SDMS also acts as a gatekeeper, serving
platform-independent data to informatics applications and/or other
consumers.

As with many other laboratory informatics tools, the lines between a

LIMS, ELN, and an SDMS are at times blurred. However, there are
NIST tests standard interfaces for its lab
some essential qualities that an SDMS owns that distinguishes it from equipment. SDMSs allow labs to integrate
other informatics systems: equipment data with other types of data.

1. While a LIMS has traditionally been built to handle structured,

mostly homogeneous data, a SDMS (and systems like it) is built to handle unstructured, mostly heterogeneous data.
2. A SDMS typically acts as a seamless "wrapper" for other data systems like LIMS and ELN in the laboratory,
though sometimes the SDMS software is readily apparent.
3. A SDMS is designed primarily for data consolidation, knowledge management, and knowledge asset realization.
[1]

An SDMS can be seen as one potential solution for handling unstructured data, which can make up nearly 75 percent
of a research and development unit's data. This includes PDF files, images, instrument data, spreadsheets, and other
forms of data rendered in many environments in the laboratory. Traditional SDMSs have focused on acting as a
nearly invisible blanket or wrapper that integrate information from corporate offices (SOPs, safety documents, etc.)
with data from lab devices and other data management tools, all to be indexed and searchable from a central
database. An SDMS also must be focused on increasing research productivity without sacrificing data sharing and
collaboration efforts.
Some of the things a standard SDMS may be asked to do include, but are not limited to[2]:
retrieve worklists from LIMS and convert them to sequence files
interact real-time with simple and complex laboratory instruments
analyze and create reports on laboratory instrument functions
perform complex calculations and comparisons of two different sample groups
monitor environmental conditions and react when base operating parameters are out of range
act as an operational database that allows selective importation/exportation of ELN data
manage workflows based on data imported into the SDMS
validate other computer systems and software in the laboratory
Scientific data management system 96

SDMS vendors
See the SDMS vendor page for a list of SDMS vendors past and present.

References
[1] Wood, Simon (2007). "Comprehensive Laboratory Informatics: A Multilayer Approach" (http:/ / www. starlims. com/
AL-Wood-Reprint-9-07. pdf), pp. 3.
[2] Heyward, Joseph E. II (2009). "Selection of a Scientific Data Management System (SDMS) Based on User Requirements" (https:/ /
scholarworks. iupui. edu/ handle/ 1805/ 2000), pp. 15 (PDF).
 97

6. Related Standards and Compliance

21 CFR Part 11
The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding
the U.S. Food and Drug Administration's (FDA) guidelines on electronic records and electronic signatures. Within
this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to
ensure electronic signatures are as legally binding as hand-written signatures.
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech and biologics companies,
contract research organizations, and other FDA-regulated industries, with some specific exceptions, to implement
controls, including audits, system validations, audit trails, electronic signatures, and documentation for closed and
open software and systems involved in processing specific electronic data. This primarily includes data to be
maintained by the FDA predicate rules and data used to demonstrate compliance to a predicate rule. A predicate rule
is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA
regulation other than Part 11. The rule also applies to submissions made to the FDA in electronic format, but not to
paper submissions by electronic methods, though paper submissions may eventually be prohibited by the FDA.

History
By the early 1990s, food and drug manufacturers approached the U.S. Food and Drug Administration (FDA) about
the possibility of electronic submissions with electronic signatures. However, at that time the government did not
allow for digital signatures. In July 1992, the FDA began soliciting comments about the process of using electronic
signatures.
In March 1997, the FDA issued Part 11 regulations which, in the words of the FDA, were "intended to permit the
widest possible use of electronic technology, compatible with FDA's responsibility to protect the public health."
Various keynote speeches by FDA insiders early in the 21st century (in addition to compliance guides and draft
guidance documents) as well as strong efforts by the FDA to motivate industry to move to e-filing resulted in many
companies like Eli Lilly, Agilent Technologies, and other businesses rapidly being forced to change their methods
and systems to adapt to the new standards.
However, many entities expressed concerns about the Title 11 conditions, including concerns the regulations would
"unnecessarily restrict" the use of technology, add significant compliance costs beyond what was intended, and stifle
technological innovation while reducing public health benefit. In November 2002, the FDA released the guidance
document "Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of
Electronic Records" to the public for commenting. On February 3, 2003, the FDA withdrew that document, stating
"we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft
guidance may no longer represent our approach under the [current good manufacturing practice] initiative," adding it
would afterwards "intend to exercise enforcement discretion with regard to certain Part 11 requirements." Further
guidance documents were withdrawn later that month, culminating in a final guidance document in August 2003
stating the government body would re-examine Part 11 and make necessary changes. However, the FDA reiterated
despite its retraction of the guidance documents "21 CFR Part 11 is not going away, and neither is the agency's
demand for electronic record integrity." The retraction of guidance and change in policy, however, led many IT
members in the pharmaceutical and life sciences industry in late 2004 to state one of the key problems they face as
the lack of clear guidelines from the FDA about what is required for compliance.
21 CFR Part 11 98

The FDA had indicated it would produce a revised version of Part 11 by the end of 2006, after its Third Annual FDA
Information Management Summit had concluded. Those revisions never arrived, and little in the way of updates on
the topic arrived. On July 8, 2010, the FDA announced it would begin to audit facilities working with drugs "in an
effort to evaluate industry's compliance and understanding of Part 11 in light of the enforcement discretion," leaving
some to wonder if this was an indicator the regulation and/or its guidance would finally see a revision.

Structure
The structure of Part 11 is as follows:
Subpart A General Provisions
11.1 Scope [1]
11.2 Implementation [2]
11.3 Definitions [3]
Subpart B Electronic Records
11.10 Controls for closed systems [4]
11.30 Controls for open systems [5]
11.50 Signature manifestations [6]
11.70 Signature/record linking [7]
Subpart C Electronic Signatures
11.100 General requirements [8]
11.200 Electronic signature components and controls [9]
11.300 Controls for identification codes/passwords [10]

Subpart A
This is essentially the preamble of the regulations, explaining to what and who the regulations apply as well as how
they'll apply. Definitions of common terms appearing in the regulations can also be found here, including a
clarification in the difference between a digital and electronic signature.

Subpart B
This section covers the requirements applicable to electronic records and their management. Several requirements
are addressed, including "how to ensure the authenticity, integrity, and, when appropriate, the confidentiality of
electronic records"; what content a signature should contain; and how electronic records and their signatures should
be linked. It also covers topics like system validation, data traceability, audit control, and version control.

Subpart C
This final section addresses the requirements specific to electronic signatures and their use. General requirements for
electronic signatures, their components and controls, and password controls are all addressed. Additionally, this
section addresses requirements for more advanced biometric-based signatures.

Audit guidelines and checklist

For those auditing computer systems and IT environments for their compliance with 21 CFR Part 11 and other
regulations, a set of guidelines and checklist items may be useful.
Click the link above for the full set of guidelines and checklist items.
21 CFR Part 11 99

Further reading
"Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic
Signatures" [11]. U.S. Government Printing Office.
"CFR - Code of Federal Regulations - Title 21 - Part 11 Electronic Records; Electronic Signatures" [12]. U.S.
Food and Drug Administration.
Huber, Ludwig (15 November 2012). "Tutorial: 21 CFR Part 11 - Electronic Records and Electronic Signatures"
[13]
. LabCompliance.

References
[1] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 1
[2] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 2
[3] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 3
[4] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 10
[5] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 30
[6] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 50
[7] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 70
[8] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 100
[9] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 200
[10] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ CFRSearch. cfm?fr=11. 300
[11] http:/ / www. ecfr. gov/ cgi-bin/ retrieveECFR?gp=& SID=04a3cb63d1d72ce40e56ee2e7513cca3& r=PART& n=21y1. 0. 1. 1. 8
[12] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ cfrsearch. cfm?cfrpart=11
[13] http:/ / www. labcompliance. com/ tutorial/ part11/

40 CFR Part 3
The Title 40 Code of Federal Regulations Part 3 (40 CFR Part 3) sometimes referred to as the Cross-Media
Electronic Reporting Rule (CROMERR) provides for electronic reporting (in lieu of a paper document) to the
U.S. Environmental Protection Agency (EPA). Within this part, requirements are created to ensure that electronic
reporting to the EPA is enacted in a satisfactory way to satisfy federal or authorized program reporting requirements,
including those requiring an electronic signature.

History
On August 31, 2001, the EPA "published a notice of proposed rulemaking, announcing the goal of making electronic
reporting and electronic recordkeeping available under EPA regulatory programs." However, the EPA had been
working on plans related to such a proposal (referred to as Cross-Media Electronic Reporting) well before, stating in
its review of its final rule that the process actually "reflects more than ten years of interaction with stakeholders,"
including "electronic reporting pilot projects conducted with state agency partners, including the States of
Pennsylvania, New York, Arizona, and several others." This also involved collaboration with more than half of U.S.
states in May 1997 on the State Electronic Commerce/Electronic Data Interchange Steering Committee (SEES) and a
series of conferences starting in 1999 to acquire stakeholders' thoughts. Public commenting closed on February 27,
2002, with the EPA receiving 184 collection of written comments. The EPA made additional adjustments to the
proposal, which culminated in a final version of CROMERR that was codified into Title 40 as Part 3 on October 13,
2005 and made effective January 11, 2006.
On December 24, 2008, minor adjustments were made to CROMERR that extended compliance dates for existing
systems making the transition to electronic filing to the EPA.
40 CFR Part 3 100

Structure
The structure of Part 3 is as follows:
Subpart A General Provisions
3.1 Who does this part apply to? [1]
3.2 How does this part provide for electronic reporting? [2]
3.3 What definitions are applicable to this part? [3]
3.4 How does this part affect enforcement and compliance provisions of Title 40? [4]
Subpart B Electronic Reporting to EPA
3.10 What are the requirements for electronic reporting to EPA? [5]
3.20 How will EPA provide notice of changes to the Central Data Exchange? [6]
Subpart C [Reserved]
Subpart D Electronic Reporting Under EPA-Authorized State, Tribe, and Local Programs
3.1000 How does a state, tribe, or local government revise or modify its authorized program to allow
electronic reporting? [7]
3.2000 What are the requirements authorized state, tribe, and local programs' reporting systems must meet?
[8]

Appendix 1 to Part 3 Priority Reports [9]

Subpart A
This is essentially the preamble of the regulations, explaining to what and who the regulations apply as well as how
they'll apply. Definitions of common terms appearing in the regulations can also be found here, including a
description of electronic signature devices.

Subpart B
This section covers the requirements applicable to electronic record formats and their submission to the EPA's
Central Data Exchange (CDX) or other related EPA systems. It also provides guidelines on how the EPA will notify
CDX users of hardware and software changes that affect transmission.

Subpart C
Subpart C is blank, "reserved for future EPA electronic recordkeeping requirements."

Subpart D
This final section provides in-depth requirements for revising state, local, and tribal government programs for
electronic submissions as well as outlining the reporting system requirements. In particular it lays out a list of
requirements for data generated from electronic document receiving systems, including security, audit trail, quality
control, and electronic signatures.
40 CFR Part 3 101

Central Data Exchange

The EPA's Central Data Exchange (CDX) is used by EPA offices, local and state governments, private industries,
and Indian tribes required to submit environmental data related to more than 60 programs in the United States,
including the Greenhouse Gas Reporting Program, the RadNet program, and the Verify engine and vehicle
compliance program. The EPA touts CDX as an important component of operations as well as meeting 40 CFR Part
3 compliance, claiming reductions in reporting burdens, cost, and data transfer times as well as increases in data
quality and compliance.
As of mid-February 2015, the CDX had more than 296,000 registered users submitting data to 63 data feeds, with 10
additional data flows in development.

Further reading
CROMERR Fact Sheet [10] (PDF)
"Cross-Media Electronic Reporting" [11]. Federal Register. OFR/GPO. 13 October 2005.
"CROMERR 101: Fundamentals for States, Tribes, and Local Governments" [12] (PDF). U.S. Environmental
Protection Agency.

References
[1] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_11
[2] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_12
[3] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_13
[4] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_14
[5] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_110
[6] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_120
[7] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_11000
[8] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#se40. 1. 3_12000
[9] http:/ / www. ecfr. gov/ cgi-bin/ text-idx?c=ecfr& sid=5ff3a0efed913ef8fae9e225869688a2& rgn=div5& view=text& node=40:1. 0. 1. 1. 3&
idno=40#ap40. 1. 3_12000. 1
[10] http:/ / www. epa. gov/ CROMERR/ documents/ cromerr_fact_sheet. pdf
[11] https:/ / www. federalregister. gov/ articles/ 2005/ 10/ 13/ 05-19601/ cross-media-electronic-reporting
[12] http:/ / www. epa. gov/ cromerr/ training/ cromerr101/ cromerr_course_summary. pdf
ASTM E1578-13 102

ASTM E1578-13
ASTM E1578-13 (titled Standard Guide for Laboratory Informatics) is an active standard developed by ASTM
International, specifically Subcommittee E13.15 on Analytical Data. According to a 2012 press release from the
committee, the standard exists primarily because "the use of electronic laboratory notebooks, cloud computing, and
the adoption of lean principles has lead to an evolution in the use of LIMS and related analytics currently employed
across laboratory environments."
As of December 2014[1], seven goals are associates with the standard as it relates to laboratory information
management systems and other laboratory informatics applications:
to provide educational material to those new to laboratory informatics
to provide educational material to those already applying laboratory informatics to laboratories and associated
areas
to provide educational material to those who develop and distribute laboratory informatics applications
to describe and recommend a standardized body of terminology to both developers and users
to describe and recommend a body of requirements that are essential to system functions
to provide recommendations for tasks secondarily related to laboratory informatics, including implementation and
training
to provide recommendations for integrating laboratory informatics applications and processes into workflow

History
The standard was previously released as E1578-93 (1993), E1578-93(1999) (1999), and E1578-06 (2006). The
current standard was approved at the end of 2013.

External links
ASTM E1578-13 at ASTM International [2]

References
[1] http:/ / limswiki. org/ index. php?title=ASTM_E1578-13& action=edit
[2] http:/ / www. astm. org/ Standards/ E1578. htm
Clinical Laboratory Improvement Amendments 103

Clinical Laboratory Improvement Amendments

The Clinical Laboratory Improvement
Amendments (CLIA) of 1988 is a United States
federal statute and regulatory standards program
that applies to all clinical laboratory testing
performed on humans in the United States, except
clinical trials and basic research.

History
On December 5, 1967, the U.S. enacted Public Law
90-174, which included in Section 5 the "Clinical
Laboratories Improvement Act of 1967." CLIA '67
set regulations on the licensing of clinical
laboratories and the movement of samples in and
out of them across state lines. Laboratories would
be eligible for a full, partial, or exempt CLIA-67
license, depending on the laboratory's conducted
tests.
However, by the mid-1980s the relevancy of CLIA '67 to a vastly changed procedural and technological clinical
laboratory landscape began to be questioned. The Office of the Assistant Secretary for Health for Planning and
Evaluation (ASPE) of the U.S. Department of Health and Human Services commissioned a study to assess the
effectiveness of federal regulations affecting clinical laboratories and their goal of protecting the public health. On
April 8, 1986, the Final Report on Assessment of Clinical Laboratory Regulations by Michael L. Kenney and Don P.
Greenberg was submitted to the ASPE.

The analysis found that many federal regulations are technically obsolescent and many may be
operationally unnecessary as a result of changing laboratory technology and changed federal
reimbursement policies. Among changes recommended by the HHS-funded analysis are: (a) the
regulatory classification system based upon physical location of laboratories is no longer appropriate
and should be replaced with a classification system reflecting laboratory functions; (b) a single, uniform
set of federal regulations should be developed that covers all civilian laboratories receiving federal
reimbursement or operating in interstate commerce; (c) a revised federal regulatory system should
emphasize measures of performance such as personnel and inspection requirements; and (d) clinical
laboratory regulations should be based upon objective data to the maximum extent possible.
On August 5, 1988, a new set of proposed regulations were put forth by the Health Care Financing Administration as
Medicare, Medicaid and CLIA Programs; Revision of the Clinical Laboratory Regulations for the Medicare,
Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs. The proposal aspired "to remove outdated,
obsolete and redundant requirements, make provision for new technologies, place increased reliance on outcome
measures of performance, and emphasize the responsibilities and duties of personnel rather than the formal
credentialing requirements and detailed personnel standards in existing regulations." This ultimately led to the
proposal becoming law on October 31, 1988 under Public Law 100-578 as the Clinical Laboratory Improvement
Amendments of 1988.
Regulations for implementing CLIA continued to be developed afterwards, with the Department of Health and
Human Services considering thousands of comments to the proposed regulations. The final regulations were
published February 28, 1992, set to be effective on September 1 of the same year. The new CLIA '88 put into place
Clinical Laboratory Improvement Amendments 104

regulations concerning test complexity, certification, proficiency testing, patient test management, personnel
requirements, quality assurance, and other processes in the clinical laboratory. However, phase-in effective dates
were extended on several occasions afterwards: on December 6, 1994 in the Federal Register (59 FR 62606), May
12, 1997 in the Federal Register (62 FR 25855), October 14, 1998 in the Federal Register (63 FR 55031), and
December 29, 2000 in the Federal Register (65 FR 82941).
On January 24, 2003, the Centers for Medicare and Medicaid Services submitted their final rule (68 FR 3639),
effective April 24, 2003, affecting QC requirements for laboratories and qualification requirements for lab directors.
The final rule also made revisions to 42 CFR 493, including the renaming, reorganizing, and consolidation of similar
requirements into one section, the deletion of duplicate requirements, and the rewording of the requirements to better
clarify their original intent. It also addressed requirements regarding the entire testing process, making those
requirement better correlate with the workflow of a lab specimen in the laboratory, from acquisition to reporting of
results, including the subdivision of testing into pre-analytic, analytic, and post-analytic phases.

CLIA program
The CLIA program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical
laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of
providing information for:
diagnosis, prevention, or treatment of disease or impairment.
health assessments.
The CLIA program is designed to ensure the accuracy, reliability, and timeliness of test results regardless of where
the test was performed. Each specific laboratory system, assay, and examination is graded for level of complexity by
assigning scores of "1," "2," or "3" for each of seven criteria. A test scored as a "1" is the lowest level of complexity,
while a test scored "3" indicates the highest level. A score of "2" is assigned when the characteristics for a particular
test are ranked primarily between low- and high-level in description.
The seven criteria for categorization are:
1. Knowledge
2. Training and experience
3. Reagents and materials preparation
4. Characteristics of operational steps
5. Calibration, quality control, and proficiency testing materials
6. Test system troubleshooting and equipment maintenance
7. Interpretation and judgment
The Centers for Medicare and Medicaid Services (CMS) has the primary responsibility for the operation of the CLIA
program. Within CMS, the program is implemented by the Center for Medicaid and State Operations, Survey and
Certification Group, and the Division of Laboratory Services.
The CLIA Program is funded by user fees collected from over 244,000 laboratories, most located in the United
States.

CLIA waived tests

Under CLIA, tests and test systems that meet risk, error, and complexity requirements are issued a CLIA certificate
of waiver. In its 2014 document Administrative Procedures for CLIA Categorization - Guidance for Industry and
Food and Drug Administration Staff, the U.S. Food and Drug Administration (FDA) advises its staff that a medical
testing device originally rated moderately complex could receive a waiver "if the device is simple to use and the
sponsor demonstrates in studies conducted at the intended use sites that the test is accurate and poses an insignificant
risk of erroneous results."
Clinical Laboratory Improvement Amendments 105

While a waived test is deemed to have an acceptably low level of risk, the Centers for Disease Control and
Prevention (CDC) reminds administrators and recipients of such tests that no test is 100 percent safe:
Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this
does not mean that waived tests are completely error-proof. Errors can occur anywhere in the testing
process, particularly when the manufacturer's instructions are not followed and when testing personnel
are not familiar with all aspects of the test system. Some waived tests have potential for serious health
impacts if performed incorrectly... To decrease the risk of erroneous results, the test needs to be
performed correctly, by trained personnel and in an environment where good laboratory practices are
followed.
In November 2007, the CLIA waiver provisions were revised by the United States Congress to make it clear that
tests approved by the FDA for home use automatically qualify for CLIA waiver.

List of tests
A list of tests categorized by the FDA as waived since 2000 can be found at the FDA website [1]. As of February 17,
2015, the list included 6,669 separate test devices.

Further reading
Kenney, Michael L. (February 1987). "Quality Assurance in Changing Times: Proposals for Reform and Research
in the Clinical Laboratory Field" [2] (PDF). Clinical Chemistry 33 (2): 328336. PMID [4]3542302 [3].

External links
42 CFR 493 at the U.S. Government Printing Office [4]
CLIA Law & Regulations at CDC [5]
Chronology of CLIA Related Documents in the Federal Register & Code of Federal Regulations [6]

Notes
A couple elements of this article are reused from the Wikipedia article [7].

References
[1] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfClia/ testswaived. cfm
[2] http:/ / www. clinchem. org/ content/ 33/ 2/ 328. full. pdf
[3] http:/ / www. ncbi. nlm. nih. gov/ pubmed/ 3542302
[4] http:/ / www. gpo. gov/ fdsys/ granule/ CFR-2011-title42-vol5/ CFR-2011-title42-vol5-part493/ content-detail. html
[5] http:/ / wwwn. cdc. gov/ clia/ Regulatory/ default. aspx
[6] http:/ / wwwn. cdc. gov/ CLIA/ Regulatory/ Chronology. aspx
[7] http:/ / en. wikipedia. org/ wiki/ Clinical_Laboratory_Improvement_Amendments
Good Automated Laboratory Practices 106

Good Automated Laboratory Practices

The Good Automated Laboratory Practices (GALP) was a U.S. EPA-based conglomeration of "regulations,
policies, and guidance documents establishing a uniform set of procedures to ensure the reliability and credibility of
laboratory data." GALP is considered an expired policy by the EPA, though the true expiration date is not know.

History
Work on GALP was first started by the EPA in 1989 as an extension of its pre-existing good laboratory practice
(GLP) requirements to what they saw as a state of increasing automation in laboratories. An additional revision was
released in 1995 by the EPA.
The GALP's creation was based on six principles:
1. The system must provide a method of assuring the integrity of all entered data.
2. The formulas and decision algorithms employed by the system must be accurate and appropriate.
3. An audit trail that tracks data entry and modifications to the responsible individual is a critical element in the
control process.
4. A consistent and appropriate change-control procedure capable of tracking the system operation and application
software is a critical element in the control process.
5. Control of even the most carefully designed and implemented system will be thwarted if appropriate user
procedures are not followed.
6. Consistent control of a system requires the development of alternative plans for system failure, disaster recovery,
and unauthorized access.

Impact
GALP had a variable regulatory impact on laboratories and organizations early on. Pharmaceutical and biologics
laboratories could practically ignore the regulations while the U.S. Food and Drug Administration (FDA) and EPA
used GALP as a key guiding factor in its standards and contract renewal considerations. The Department of Energy
and Superfund programs tightly followed GALP's standards while others viewed GALP as something to be loosely
interpreted.

References
Good Automated Manufacturing Practice 107

Good Automated Manufacturing Practice

Good Automated Manufacturing Practice
(GAMP) is both a technical subcommittee of the
International Society for Pharmaceutical
Engineering (ISPE) and a set of guidelines for
manufacturers and users of automated systems in
the pharmaceutical industry. One of the core
principles of GAMP is that quality cannot be
tested into a batch of product but must be built
into each stage of the manufacturing process. As a
result, GAMP covers all aspects of production;
from the raw materials, facility and equipment to
the training and hygiene of staff.

GAMP is largely about automated system

validation. In October 2014, Irish tech company
Dataworks Ltd. described it as such:
It is a formal process of thorough
documentation, testing, and logical
process steps that validate clients'
required specifications. The process
begins with a user requirements
specification for the machine, from
which a functional requirement and a
design specification are created. The area of automated pharmaceutical manufacturing is influenced in part
by GAMP and its associated guidelines.
These documents then form the basis
for the traceability matrix and for the
formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is
used to support the approach to validation based on the difficulty and individuality of the computerised
system.

History
GAMP's origins can be traced to the United Kingdom in 1988, when software developers David Forrest and Colin
Jones, through their company FJ Systems, developed real-time control and production information management
control systems for pharmaceutical manufacturers. They worked with ICI Pharmaceuticals' Tony Margetts on the
problem of validating systems that were increasingly becoming more software-based than mechanical- and
electrical-based. This culminated in a five-page document called VMAN I, mapping the older installation
qualification (IQ), operational qualification (OQ), and performance qualification (PQ) phases of equipment
validation to a more modern software validation lifecycle. A second version was created upon additional feedback.
GAMP itself was eventually founded in 1991 (with the previously mentioned Margetts as chairman of the editorial
board) to deal with the evolving U.S. Food and Drug Administration expectations for Good Manufacturing Practice
(GMP) compliance of manufacturing and related systems. GAMP published its first draft guidance in February 1994,
with version 1.0 of it arriving in March 1995. Soon afterwards the organization entered into a partnership with ISPE,
formally becoming part of ISPE in 2000. GAMP 4 was released a year later, followed by GAMP 5 in 2008. GAMP
has enjoyed the support of numerous regulatory authorities over the years spanning the United States, Europe, and
Good Automated Manufacturing Practice 108

Japan and is now a recognized good practice worldwide.

Publications

GAMP 5
ISPE has published a series of good practice guides for the industry on several topics involved in drug
manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation
of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP 5) was released in February
2008.
The guidance generally states that pharmaceutical computer systems should be built with several key ideas in mind:
1. Make product and process understanding clear.
2. Approach the life cycle from the standpoint of a quality management system.
3. Make life cycle activities scalable.
4. Ensure quality risk management is science-based.
5. Leverage supplier involvement into the system.

System categorization
Software systems borne from these principles can be categorized into one of four GAMP 5 categories. These
classifications act as built-in risk and difficulty assessments that support different validation approaches:
Category 1: Infrastructure software - This includes "established or commercially available layered software" and
"infrastructure software tools" that are themselves validated from within rather than from the infrastructure.
Category 3: Non-configured products - This includes "software that is used as installed" and potentially "software
that is configurable (category 4) but is used either unconfigured or with the standard defaults provided by the
software supplier."
Category 4: Configured products - This includes products where "the user has the means and knowledge to change
the functionality of the device in a way that changes the results outputted by the device. As a direct consequence, this
triggers increased validation effort."
Category 5: Custom applications - This includes any "application, module, user-defined program, or macro" that has
been written in-house or by a third party that "needs to be specified, version controlled, built, and tested (including
integration testing with the commercial application, as applicable) as a minimum to ensure the quality of the
software."
Note: "Category 2: Firmware" was removed from GAMP with revision five.

Other guides
As of February 2015, the ISPE has 13 guides, the latest published in October 2014, titled A Risk-Based Approach to
Regulated Mobile Applications.

External links
International Society for Pharmaceutical Engineering (ISPE) website [1]
GAMP 4 guide [2] (PDF)
GAMP 5 guide [3]
Good Automated Manufacturing Practice 109

References
[1] http:/ / www. ispe. org
[2] http:/ / www. ssfa. it/ allegati/ GDL_GIQAR_GCP_GampGuidelineMilano06. pdf
[3] http:/ / www. slideshare. net/ ProPharmaGroup/ overview-of-computerized-systems-compliance-using-the-gamp-5-guide

Health Insurance Portability and Accountability

Act
The Health Insurance Portability
and Accountability Act of 1996
(HIPAA) was enacted by the United
States Congress and signed by
President Bill Clinton in 1996. Its
intended purpose was "to improve
portability and continuity of health
insurance coverage in the group and
individual markets; to combat waste,
fraud, and abuse in health insurance
and health care delivery; to promote
the use of medical savings accounts; to
improve access to long-term care services and coverage; [and] to simplify the administration of health insurance."

History

Initial
In 1994, U.S. President Bill Clinton attempted to overhaul the national health care system but didn't receive the
support he needed. In 1995, Senators Nancy Kassebaum (R-KS) and Edward Kennedy (D-MA) introduced a
comparatively pared down proposal called the Health Insurance Reform Act of 1995 (S 11028), later referred to
informally as the Kassebaum/Kennedy Bill. The proposal called for health insurance portability for employees,
medical savings accounts, increased deductibility of health insurance for the self-employed, and tax breaks for
long-term care insurance. The legislation successfully made it out of the Senate Labor and Human Resources
Committee on August 2, 1995, only to be stalled "because of opposition from conservative senators who shared
industry concerns over the group-to-individual portability provisions."
With desire to get some sort of health care reform legislation passed, Clinton referenced the stalled bill in his January
1996 State of the Union address on several occasions. Though some feared the ploy by Clinton would ultimately sink
the bill, it inevitably resulted in bipartisan cooperation so no one side could take credit for the bill. On February 7,
1996, the two parties agreed to further discuss the legislation in the House and Senate. This resulted in several
events: the House of Representatives created an alternative bill (HR 3103) that drew on characteristics of S 11028,
passing on March 28; the Senate passed a version of the original S 11028 on April 23 but without controversial
attachments like medical savings accounts. However, differences between the House and Senate bills caused
problems. "The House bill, for example, included provisions allowing for medical savings accounts, a limit on
monetary damages in medical malpractice lawsuits and a reduction in states' authority to regulate health insurance
purchasing pools created by small businesses." Additionally, a provision on mental health coverage was found on the
Senate bill that was omitted from the House version. It took several weeks of debating to make concessions on these
topics.
Health Insurance Portability and Accountability Act 110

A Republican-led compromise was offered on June 10, however debate raged on. It wasn't until a July 25
compromise between Kennedy and Ways and Means Committee Chairman Bill Archer (R-TX) on medical savings
accounts that momentum shifted. Provisions on mental illness and medical malpractice were eventually dropped
from the proposal on July 31, with both House and Senate agreeing on the final version on August 1 and August 2
respectively. On August 21, 1996, the legislation was signed into law by President Clinton and codified as Public
Law 104-191, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Amendments
The administrative simplification provisions in HIPAA meant more work had to be done in regards to the legislation.
The U.S. Department of Health and Human Services (HHS) began work on the HIPAA Privacy Rule in 1999,
"which set out detailed regulations regarding the types of uses and disclosures of personally identifiable health
information that are permitted by the covered entities." However, large volumes of comments and Executive branch
changes in 2000 slowed the process down. Several more years of corrections and requests for comments followed,
culminating in the release of the Final Rule on August 14, 2002 as 45 CFR Part 160 and Subparts A and E of Part
164. Most health plans were expected to be in compliance by April 14, 2003, though some exceptions existed.
Despite the Privacy Rule, many still argued that the legislation wasn't suitable enough to prevent mishandling of
personal health information and that it was impeding research. These concerns mixed with few incidents of
enforcement in the first few years after the 2003 compliance date prompted additional review by the HHS. On
February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement, to be effective March 16, 2006.
Additional updates to the enforcement rule came with the Health Information Technology for Economic and Clinical
Health Act (HITECH) Act, enacted on February 17, 2009. The Act added "several provisions that strengthen the
civil and criminal enforcement of the HIPAA rules" by adding categories of violations and tier levels of penalty
amounts. HIPAA and the HITECH statutes were further revised in January 2013 (effective March 26, 2013) "to
strengthen the privacy and security protection for individuals health information," update the Breach Notification
Rule, "strengthen the privacy protections for genetic information," and revise other portions of HIPAA rules "to
improve their workability and effectiveness."

Structure
HIPAA is divided into five titles, each with their own subtitles:
Title I: Health Care Access, Portability, and Renewability
Subtitle A - Group Market Rules
Subtitle B - Individual Market Rules
Subtitle C - General and Miscellaneous Provisions
Title II: Preventing Health Care Fraud and Abuse; Administrative Simplification; Medical Liability Reform
Subtitle A - Fraud and Abuse Control Program
Subtitle B - Revisions to Current Sanctions for Fraud and Abuse
Subtitle C - Data Collection
Subtitle D - Civil Monetary Penalties
Subtitle E - Revisions to Criminal Law
Subtitle F - Administrative Simplification
Subtitle G - Duplication and Coordination of Medicare-Related Plans
Title III: Tax-Related Health Provisions
Subtitle A - Medical Savings Accounts
Health Insurance Portability and Accountability Act 111

Subtitle B - Increase in Deduction for Health Insurance Costs of Self-Employed Individuals

Subtitle C - Long-Term Care Services and Contracts
Subtitle D - Treatment of Accelerated Death Benefits
Subtitle E - State Insurance Pools
Subtitle F - Organizations Subject to Section 833
Subtitle G - IRA Distributions to the Unemployed
Subtitle H - Organ and Tissue Donation Information Included With Income Tax Refund Payments
Title IV: Application and Enforcement of Group Health Plan Requirements
Subtitle A - Application and Enforcement of Group Health Plan Requirements
Subtitle B - Clarification of Certain Continuation Coverage Requirements
Title V: Revenue Offsets
Subtitle A - Company-Owned Life Insurance
Subtitle B - Treatment of Individuals Who Lose United States Citizenship
Subtitle C - Repeal of Financial Institution Transition Rule to Interest Allocation Rules

Description
Title I of HIPAA contains three subtitles that protect health insurance coverage for workers and their families when
they change or lose their jobs.
Title II of HIPAA contains seven subtitles. One of the most important for expanding HIPAA is Subtitle F, the
Administrative Simplification (AS) provisions, requiring the establishment of national standards for electronic health
care transactions and national identifiers for providers, health insurance plans, and employers. Title II also addresses
the security and privacy of health data, with the intent of improving the efficiency and effectiveness of the nation's
health care system by encouraging the widespread use of electronic data interchange in the U.S. health care system.
Title III of HIPAA modifies the Internal Revenue Code (IRC) to revise available tax deductions for health insurance,
clarify how pre-tax money could be applied health payments, and regulate long-term care services and how they're
contracted. Other tax-related issues like IRA distribution and organ donor tax refund payments are covered by this
title, in total spread out over eight subtitles.
Title IV of HIPAA modifies both the IRC and the Public Health Service Act (PHSA) to describe requirements for
and enforcement of how group health plans could legally manage and cover patients' pre-existing conditions as well
as their continuation of coverage. This information is supplied over two subtitles.
Title V of HIPAA contains three subtitles that amend the IRC concerning miscellaneous issues such as interest
deductions on loans related to company-owned life insurance, how individuals who lose their U.S. citizenship shall
be treated tax-wise, and the removal of certain limitations on interest allocation.

Enforcement
On February 16, 2006, HHS issued the Final Rule regarding HIPAA enforcement. It became effective on March 16,
2006. The Enforcement Rule set civil money penalties for violating HIPAA rules and established procedures for
investigations and hearings for HIPAA violations. Before the enforcement rule, the deterrent effects of the legislation
seemed negligible, with few prosecutions for violations. Enforcement operations were ratcheted up further with the
passage of the Health Information Technology for Economic and Clinical Health Act (HITECH) in 2009, which
greatly increased the financial penalties that could be applied to entities in non-compliance.
By the end of 2014, the U.S. Department of Health and Human Resources (HHS) reported investigating 106,522
HIPAA complaints against national pharmacy chains, major health care centers, insurance groups, hospital chains
Health Insurance Portability and Accountability Act 112

and other small providers since April 2003. The HHS reported 23,314 of those cases had been resolved by requiring
changes in privacy practice or by corrective action. 10,566 cases were investigated and found that HIPAA was
followed correctly. Another 68,412 cases were found to be ineligible for enforcement because, for example, a
violation occurred before HIPAA became effective, a case was withdrawn by the pursuer, or an activity did not
actually violate the rules.
According to the HHS, the most commonly investigated compliance issue, by order of frequency, have been:
1. incorrectly used or revealed protected health information (PHI);
2. insufficient protection mechanisms for PHI;
3. insufficient mechanisms for patients to access their PHI;
4. insufficient administrative protections and tools for managing electronic PHI; and
5. usage and disclosure of more PHI than minimally necessary.
The HHS also stated the entities most likely to be responsible for infractions, by order of frequency, have been:
1. private practices;
2. general hospitals;
3. outpatient facilities;
4. pharmacies; and
5. health plans (group health plans and health insurance issuers).

Assessed impact
The enactment of HIPAA caused major changes in the way physicians and medical centers operate. The complex
legalities and potentially stiff penalties associated with HIPAA, as well as the increase in paperwork and the cost of
its implementation, were causes for concern among physicians and medical centers. Many of those concerns were
expressed in an August 2006 paper published in the journal Annals of Internal Medicine. It mentioned a University
of Michigan study that demonstrated how the implementation of the HIPAA Privacy rule resulted in a drop from 96
percent to 34 percent in the proportion of follow-up surveys completed by study patients being followed after a heart
attack.
By 2013, views on the impact of HIPAA were mixed. Leon Rodriguez, director of the HHS' Office for Civil Rights
said of HIPAA:
Whereas many thought HIPAA would "bankrupt" healthcare, shut down research, and otherwise
paralyze the industry, instead the industry has learned the benefits of the transaction and code set
standards through the ease of electronic transactions. And the balance of the [HIPAA] Privacy and
Security protections have paved the way to real benefits for consumers through greater access to quality
care.
In an article for the Houston Chronicle, writer and business consultant Lisa Dorward stated the following for patients
requesting personal health information:
Direct cost to patients is minimal; health care institutions can charge the patient only for copying and
postage costs for delivery of the documents. On the other hand, costs to health care providers are high
and can strain already overburdened budgets. Some clinics and hospitals have had to reconstruct or
remodel existing registration areas to comply with HIPAA's privacy regulations.
Writing for the Loyola Consumer Law Review, attorney and legal writer Anna Colvert wrote:
Generally, HIPAA is considered a step in the right direction regarding patient privacy, and it has
resulted in more descriptive and detailed privacy policies; however, it has not improved the online
privacy practices of these organizations. While HIPAA is a solid foundation in protecting patients
healthcare information there is more work to be done..."
Health Insurance Portability and Accountability Act 113

A May 2013 Computerworld reported on a survey conducted by the Ponemon Institute that found 51 percent of
respondents believed "HIPAA compliance requirements can be a barrier to providing effective patient care" and 59
percent "cited the complexity of HIPAA requirements as a major barrier to modernizing the healthcare system."

Audit guidelines and checklist

For those auditing computer systems and IT environments for their compliance with the Health Insurance Portability
and Accountability Act and other regulations, a set of guidelines and checklist items may be useful.
Click the link above for the full set of guidelines and checklist items as they relate to HIPAA.

Further reading
"Public Law 104 - 191 - Health Insurance Portability and Accountability Act of 1996" [1]. U.S. Government
Publishing Office.
"S. 1028 (104th): Health Insurance Reform Act of 1995" [2]. GovTrack.us. Civic Impulse, LLC.
"Bill Makes Health Insurance Portable" [3]. CQ Almanac 1996 52: 6-286-39. 1997.

References
[1] http:/ / www. gpo. gov/ fdsys/ pkg/ PLAW-104publ191/ content-detail. html
[2] https:/ / www. govtrack. us/ congress/ bills/ 104/ s1028
[3] http:/ / library. cqpress. com/ cqalmanac/ document. php?id=cqal96-1092479

Health Level 7
Health Level Seven (HL7) is an
international non-profit
volunteer-based organization involved
with the development of international
health care informatics interoperability
standards. The HL7 community
consists of health care experts and
information scientists collaborating to
create standards for the exchange,
management, and integration of
electronic health care information.

The term "HL7" is also used to refer to

some of the specific standards created
by the organization (e.g., HL7 v2.x,
v3.0, HL7 RIM). HL7 and its members The Reference Information Model (RIM) is an important component of the HL7 v3.0
provide a framework (and related standard and is based on XML.
standards) for the exchange,
integration, sharing, and retrieval of electronic health information. v2.x of the standards, which support clinical
practice and the management, delivery, and evaluation of health services, are the most commonly used in the world.
Health Level 7 114

History
The International Organization for Standardization (ISO) got involved with standardizing network exchanges of data
between computers around 1979, creating the Open Systems Interconnect (OSI) standards model. These formal OSI
standards ranged across seven levels, from OSI Level 1 (physical layer, e.g. communication over coaxial cable) to
OSI Level 7 (application layer, e.g. communication between clinical software). By 1981, researchers at University of
California - San Francisco had created a proprietary protocol that unbeknownst to them at the time fit under the OSI
Level 7 model. The protocol was developed for clinical purposes such that "computers exchanged several core
messages, including the synchronization of patient admission-discharge-transfer information, orders from clinical
areas, and the display of textual results to the clinical areas."
By 1985, Simborg Systems (which developed hospital information systems) sought to have a non-proprietary
protocol created because "standardization efforts at the time was either fragmented, in a different direction or with a
different scope." This led to a push to create a new standards organization, with initial meetings occurring at the end
of March 1987. The meetings produced the term "HL7" and prompted a non-profit organization to be created,
eventually known as Health Level Seven International. Version 1.0 of the HL7 specification was released in October
1987. The direction of HL7 was largely led by Simborg Systems; however, with greater practical use seen in
furthering the protocol and non-profit, the first non-Simborg Systems chairperson, Ed Hammond, took the reigns in
1989. By June 1990, Version 2.1 was published and included mechanisms for results reporting and billing. By the
early- to mid-1990s news of HL7 was beginning to spread to international clinical sectors, particularly parts of
Europe, including Netherlands, Germany, Canada, Japan, Australia, and the United Kingdom.
In June 1994 the American National Standards Institute (ANSI) awarded Health Level 7 International status as an
accredited standards developer. Version 2.2 became an official ANSI standard in February 1996. HL7 had roughly
1,700 members from various health care industries around the globe by the late 1990s.
Version 3.0 of the HL7 standard was released in late 2005, which internationalized it and made it more consistent
and precise. Where the 2.x standards eventually received wide adoption for their flexibility and available
implementation options, the 3.0 standards, in contrast, departed from that flexibility in order to be more "definite and
testable, and provide the ability to certify vendors' conformance." In 2009, Corepoint Health reported that most HL7
messaging was occurring using 2.3 and 2.3.1 models, with 3.0-based messages representing only a tiny fraction of all
interfaces; in 2012 Corepoint Health's Rob Brull estimated that more than 90 percent of all healthcare systems were
still utilizing 2.x models. That trend continued, with several experts proclaiming the standard to be more or less a
failure.
In early 2012, HL7 announced the HL7 FHIR (Fast Healthcare Interoperability Resources) initiative, which would
utilize the best aspects of both 2.x and 3.0 standards, optimally resulting in a standard that is 20 percent the size of
3.0 but still meet the operation requirements of 80 percent of systems using the standard. FHIR is being built on
RESTful web services and provides modular, extensible "resources" to provide some flexibility but within a more
fixed framework. In December 2014, HL7 announced the Argonaut Project, meant "to hasten current FHIR
development efforts in order to create practical and focused guidelines and profiles for FHIR by the spring of 2015."

Standards
In total HL7 develops conceptual standards (e.g., HL7 RIM), document standards (e.g., HL7 CDA), application
standards (e.g., HL7 CCOW), and messaging standards (e.g., HL7 v2.x and v3.0). Messaging standards are
particularly important because they define how information is packaged and communicated from one party to
another. Such standards set the language, structure, and data types required for seamless integration from one system
to another. Business use of the HL7 standards requires a paid organizational membership in HL7, Inc. HL7 members
can access standards for free, and non-members can buy the standards from HL7 or ANSI.
Health Level 7 115

HL7 v2.x and 3.0 are the primary standards from the organization. They provide a framework for data exchange
among clinical and healthcare systems in an ideal format. The 2.x standards are flexible, with several implementation
options, loosely geared towards "clinical interface specialists" working to move clinical data in the application space.
The 3.0 standards are designed to be more fixed, precise, and international, geared towards governments and end
users of clinical applications.
While HL7 v2.x and 3.0 are the primary standards, a few other important standards and components are associated
with HL7, as detailed below.

Reference Information Model (RIM)

The Reference Information Model (RIM) is an important component of the HL7 Version 3 standard. RIM expresses
the data content needed in a specific clinical or administrative context and provides an explicit representation of the
semantic and lexical connections that exist between the information carried in the fields of HL7 messages. The
standard is accepted as official by the ISO as ISO/HL7 21731; the original was approved in 2006, with a revised
version appearing in 2014.

Clinical Document Architecture (CDA)

The Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding,
structure, and semantics of clinical documents for exchange. The standard is accepted as official by the ISO as
ISO/HL7 27932; the most current version comes from 2009.

Clinical Context Object Workgroup (CCOW)

The Clinical Context Object Workgroup (CCOW) family of standards are designed to enable disparate applications
to share user context and patient context in real-time, particularly at the user-interface level. CCOW implementations
typically require a CCOW vault system to manage user security between applications. The primary standard under
CCOW is the Context Management Specifications (CCOW), which "serves as the basis for ensuring secure and
consistent access to patient information from heterogeneous sources." This standard is accepted as official by ANSI
as ANSI/HL7 CMS V1.6.

Fast Healthcare Interoperability Resources (FHIR)

The Fast Healthcare Interoperability Resources (FHIR) standard was announced in 2012 and has been in
development since. FHIR is being built on RESTful web services and provides modular, extensible "resources" to
provide some flexibility but within a more fixed framework. The fundamental principles of FHIR are:
prioritize implementers as the target user of the standard;
provide a flexible framework for interoperability;
limit complexity to where it's most needed;
keep conformance requirement minimal but also provide varying degrees of rigor;
leverage open source development principles;
make the standard available without cost;
support multiple exchange architectures;
leverage common web technologies;
make the standard forward and backward compatible; and
design, publish, and implement associated specifications using widely available tools.
Health Level 7 116

Further reading
Introduction to HL7 Standards [1]
Spronk, Ren (05 September 2014). "The Early History of Health Level 7" [2]. Ringholm BV.

External links
Health Level 7 International [3]
HL7 Wiki [4]
HL7 FHIR [5]

References
[1] http:/ / www. hl7. org/ implement/ standards/ index. cfm
[2] http:/ / www. ringholm. com/ docs/ the_early_history_of_health_level_7_HL7. htm
[3] http:/ / www. hl7. org/
[4] http:/ / wiki. hl7. org/ index. php?title=Main_Page
[5] http:/ / wiki. hl7. org/ index. php?title=FHIR

ISO 9000
ISO 9000 is a family of standards
related to quality management systems
and designed to help organizations
ensure that they meet the needs of
customers and other stakeholders. The
standards are published by the
International Organization for
Standardization (ISO) and are
available through national standards
bodies. ISO 9000 deals with the
fundamentals of quality management
systems , including the eight
management principles on which the
family of standards is based.
A General Motors assembly plant advertises its ISO 9001 certification.

ISO 9001 deals with the requirements

that organizations wishing to meet the standard have to fulfill. Third party certification bodies provide independent
confirmation that organizations meet the requirements of ISO 9001. Over a million organizations worldwide are
independently certified, making ISO 9001 one of the most widely used management tools in the world today.
Despite widespread use, however, the ISO certification process has been criticized as being wasteful and not being
useful for all organizations.
ISO 9000 117

History
The ISO 9000 family of standards was originally built on several British standards developed in the early 1970s: BS
9000, BS 5179, and BS 5750. These quality assurance standards were initially related to the electronics
manufacturing industry and set guidelines on managing supply-side quality through auditing and contractual
documentation. However, the history of ISO 9000 can be traced back even further to the publication of the United
States Department of Defense MIL-Q-9858 standard in 1959. MIL-Q-9858 was revised into the NATO AQAP series
of standards in 1969, which in turn were revised into the BS 5179 series of guidance standards published in 1974,
and finally revised into the BS 5750 series of requirements standards in 1979.
As the idea of company certification of meeting a certain level of quality became more attractive, the push for a more
rigorous international standard (primarily led by the British Standards Institute [BSI]) resulted in the creation of the
ISO 9000 family in 1987. Originally based on BS 5750, the ISO 9000 family started out with three quality
management models and a set of guidelines for following them:
ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing
ISO 9002:1987 Model for quality assurance in production, installation, and servicing
ISO 9003:1987 Model for quality assurance in final inspection and test
ISO 9004.1:1987 Quality management and quality system elements - Part 1: Guidelines

Changes to ISO 9000

In 1994, the ISO 9000 standards were updated to place focus on the importance of quality control and preventative
action, and emphasize the need for the documentation of procedures.
In 2000, ISO 9001, 9002, and 9003 were combined into ISO 9001:2000, with a major shift in focus towards quality
management versus quality control as well as a focus on process management, "the monitoring and optimizing of a
company's tasks and activities, instead of just inspecting the final product." It directed manufacturers to carefully
examine client requirements in order to design and improve processes and improve customer satisfaction.
The 2008 changes to ISO 9001 were minimal, clarifying and simplifying language while making it more consistent
with other standards.
The ISO 9004 guidelines document was updated in 2009 "to promote a sustainable business approach" that focused
on all stakeholders.
An updated version of ISO 9001 is expected at the end of 2015 if the ISO members vote favorably in the second
quarter of 2015. With the revision the scope of the standard will not change. An essential change, however, will
affect the structure. The new ISO 9001:2015 will follow the so-called high-level structure. This, and the uniform use
of core texts and terms, will enable an identical structure for all management systems.

Adoption of the standard

The global adoption of ISO 9001 may be attributable to a number of factors. Many major purchasers require their
suppliers to hold ISO 9001 certification. In addition to several stakeholders' benefits, a number of studies have
identified significant financial benefits for organizations certified to ISO 9001. Examples include:
1. In 2002, Heras et al. found superior return on assets compared to otherwise similar organizations without
certification and demonstrated that this was statistically significant and not a function of organization size.
2. A 2003 study of 146 Singapore-based companies by Chow-Chua et al. found improved financial performance,
though with the caveat "that while certification leads to better overall financial performance, nonlisted certified
firms experience better documentation procedures, higher perceived quality of products or services, and more
effective communication among employees than listed certified firms."
ISO 9000 118

3. That same year Rajan and Tamimi showed that ISO 9001 certification resulted in superior stock market
performance and suggested that shareholders were richly rewarded for investing in the certified companies.
4. In 2005, Corbett et al. showed in 2005 similar superior performance, atating that "three years after certification,
the certified firms do display strongly significant abnormal performance under all control-group specifications."
5. That same year, Sharma linked increases in "operating efficiency, growth in sales, and overall financial
performance" gains with ISO 9000 certification.
6. Naveha and Marcus claimed in 2007 that manufacturers in the U.S. automotive industry that implemented ISO
9001 saw superior operational performance soon after.
7. A 2011 survey from The British Assessment Bureau showing 44 percent of their certified clients had won new
business due to becoming certified.
While the connection between superior financial performance and ISO 9001 may be seen from the examples cited,
there remains no proof of direct causation, though longitudinal studies such as those of Corbett et al. may suggest it.
Other researchers such as Heras et al. have suggested that while there is some evidence of this, the improvement is
partly driven by the fact that there is a tendency for better performing companies to seek ISO 9001 certification.

Criticisms of the standard

A common criticism of the ISO 9000 family of standards is the amount of money, time, and paperwork required for
registration. In 2003, writing for Quality Magazine, engineer Scott Dalgleish emphasized that "[u]nder ISO, every
quality system enhancement triggers enormous documentation changes that make quality managers question whether
the benefits of the change are worth the effort." In a piece for Inc. magazine in 2005, journalist Stephanie Clifford
told the story of Delaware North Companies, which spent nearly 18 months and $115,000 just to certify their guest
services management division.
Others have chosen not to adopt the standard because of the perceived risks and uncertainty of not knowing if there
are direct relationships to improved quality as well as doubts about what kind and how many resources will be
needed. Other perceived risks include how much certification will cost, increased bureaucratic processes, and risk of
poor company image if the certification process fails. Critics like John Seddon, a leading global authority on the
service industry, claim ISO 9001 promotes specification, control, and procedures rather than understanding and
improvement. Others like business improvement specialist Jim Wade have argued that ISO 9001 is effective as a
guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means
better quality, ... [undermining] the need for an organization to set its own quality standards." In short, Wade argues
that reliance on the specifications of ISO 9001 does not guarantee a successful quality system.
The standard has been seen as especially prone to failure when a company is interested in certification before quality.
Certifications have in fact often been based on customer contractual requirements rather than a desire to actually
improve quality. "If you just want the certificate on the wall, chances are you will create a paper system that doesn't
have much to do with the way you actually run your business," said ISO's Roger Frost in 2001. Certification by an
independent auditor is often seen as the problem area, and according to Barnes, it "has become a vehicle to increase
consulting services."
ISO 9000 119

Further reading
Cochran, Craig (2008). ISO 9001 in Plain English [1]. Paton Professional. pp.178. ISBN [2]9781932828207.

External links
ISO 9000 [2] at the International Organization for Standardization

Notes
This article reuses a few elements from the Wikipedia article [3].

References
[1] https:/ / books. google. com/ books?id=-GplCM5xTYYC
[2] http:/ / www. iso. org/ iso/ iso_9000
[3] http:/ / en. wikipedia. org/ wiki/ ISO_9000

ISO/IEC 17025
ISO/IEC 17025 is an International
Organization for Standardization (ISO)
standard used by testing and
calibration laboratories to provide a
basis for accreditation of laboratory
quality systems. There are many
commonalities with the ISO 9000
family of standards, but ISO/IEC
17025 adds in the concept of
competence to the equation, applying
directly to those organizations that
produce testing and calibration results.

Even military testing and calibration labs like the Navy Standards Laboratory (WPP) opt

History to get ISO/IEC 17025 certified.

ISO/IEC 17025 was originally known as ISO/IEC Guide 25, first released in 1978, with subsequent editions
following in 1982 and 1990. Guide 25 was created with the belief that "third party certification systems [for
laboratories] should, to the extent possible, be based on internationally agreed standards and procedures." In the mid-
to late 1990s, an update to Guide 25 was required. However, the ISO decided to convert the guide into a standard
and introduce tight compatibility with ISO 9001, which was also being revised, such that ISO 9001 would be treated
as a master standard and the next evolution of Guide 25 to be treated as a standard to be specifically applied to
testing and calibration laboratories.

ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release
was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000
version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior
management, as well as explicit requirements for continual improvement of the management system itself,
particularly communication with the customer.
ISO/IEC 17025:1999 became defunct in May 2007.
ISO/IEC 17025 120

The standard
The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions,
management requirements, and technical requirements. Two annexes are also included. In particular the management
and technical requirements are the most important sections, with the management requirement section detailing the
operation and effectiveness of the quality management system within the laboratory and the technical requirements
section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in
laboratory.
The standard is organized as follows:

Scope
The scope of the standard is described over six points. It states what type of testing and calibration is covered; who
it's applicable to; the purpose for the standard; what's not covered; and how it relates to ISO 9001.

Normative references
This section states both ISO/IEC 17000 and the International Vocabulary of Metrology (VIM) are vital to applying
the standard.

Terms and definitions

This sections simply states that relevant terms found in the standard can be defined via ISO/IEC 17000 and VIM.

Management requirements
The requirements for the operational effectiveness of a laboratory's quality management system are outlined in this
section. The requirements are broken down into 15 subsections:
4.1 Organization
4.2 Management system
4.3 Document control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
ISO/IEC 17025 121

Technical requirements
The requirements for staff competence, methodologies, equipment testing and calibration, and test methods are
outlined in this section. The requirements are broken down into 10 subsections:
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the quality of the test and calibration results
5.10 Reporting the results

Annexes
Two annexes and a bibliography are included. Annex A: Nominal cross-references to ISO 9001:2000 provides links
between this standard and ISO 9001, important as this standard includes requirements not covered in ISO 9001.
Annex B: Guidelines for establishing applications for specific fields gives accreditation seekers explanations of
specific requirements to better complete their applications.

Accreditation
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently
produce valid results. It is also the basis for accreditation from an accreditation body. Since the standard is about
competence, accreditation is simply formal recognition of a demonstration of that competence. A prerequisite for a
laboratory to become accredited is to have a documented quality management system. The usual contents of the
quality manual follow the outline of the ISO/IEC 17025 standard.
National accreditation bodies are primarily responsible for accrediting laboratories to ISO/IEC 17025. Laboratories
can use either a domestic organization or some other internationally recognized body in cases where the domestic
organization "has either no international recognition or where it lacks recognition in parts of the world relevant to the
laboratorys operations." Laboratories typically select a range of common and frequently used methodologies that
could readily benefit and demonstrate a comprehensive quality system that those methodologies run under.
ISO/IEC 17025 122

Further reading
"Complying with ISO 17025" [1] (PDF). United Nations Industrial Development Organization. October 2009. pp.
106.

External links
ISO 17025:2005 [2]
ISO 17025:2005 [3] on the ISO Online Browsing Platform

References
[1] http:/ / www. unido. org/ fileadmin/ user_media/ Publications/ Pub_fr/ Complying_with_ISO_17025_A_practical_guidebook. pdf
[2] http:/ / www. iso. org/ iso/ catalogue_detail. htm?csnumber=39883
[3] https:/ / www. iso. org/ obp/ ui/ #iso:std:iso-iec:17025:ed-2:v1:en

ISO/TS 16949
ISO/TS 16949 is an International
Organization for Standardization (ISO)
technical specification for the
development of a quality management
system, specifically for the
development, production, and, when
relevant, installation and servicing of
automotive-related products. The
standard provides for continual
improvement of these processes,
emphasizing defect prevention and the
reduction of variation and waste in the
supply chain. It is based on the ISO
Manufacturers of automotive parts supplied to automakers most certainly must get
9001 standard.
ISO/TS 16949 certified to remain competitive.

History
ISO/TC 16949 is based on DaimlerChrysler, Ford, and General Motors' QS-9000 quality systems standards as well
as the ISO 9000 family of standards. In June 1988, at the ASQ Automotive Division conference, a group of parts
suppliers suggested to the attending vice presidents the need for a set of quality assessment standards separate from
the ISO 9000 standards, which were introduced only a year earlier. At that time suppliers noted that ISO 9000
"lacked some elements in current automotive industry documents, such as business plans, customer satisfaction,
continuous improvement, manufacturing capabilities, and much of the advanced quality planning content." The
QS-9000 manual based on content from ISO 9001 was eventually released in August 1994, followed by a
second edition in February 1995, which caught on worldwide with other original equipment manufacturers (OEMs).
A few months later, at a European QS-9000 implementation meeting, representatives for the U.S. automakers
learned that similar efforts had already been underway in the forms of "VDA 6.1 in Germany, AVSQ in Italy, and
EAQF in France." A desire to further unify these disparate standards was expressed, resulting in the creation of the
International Automotive Task Force (IATF).
ISO/TS 16949 123

The ISO Technical Committee (TC) 176, responsible for quality management and assurance standards, took notice
and, not wanting to fraction ISO 9000 standards into sector-specific branches, attempted to convince the IATF to
adopt ISO 9000. However, after several meetings, the TC 176 agreed the family of standards was not comprehensive
enough for the automotive industry and vowed to include updates in the next version. Though the technical
committee worked with the IATF, their needs were different enough that the automotive-specific changes would not
be able to make it into the upcoming 2000 iteration. By November 1997, the two groups agreed on using the ISO
technical report as a tool for the requirements, which would be based off of ISO 9001:1994.
By the time the first draft document was created in the fall of 1998, a new type of ISO document became available: a
Technical Specification (TS). The IATF agreed to this format, and in November 1998, ISO/TS 16949 was initially
approved as the first ISO Technical Specification, with a second official printing arriving in March 1999. In March
2002, a revised ISO/TS 16949:2002 was released to align with changes to ISO 9001, putting more focus on how "to
improve effectiveness and efficiency of the entire process instead of a narrow focus on mere compliance with
standards." The current version is ISO/TS 16949:2009. It was released in July 2009 and draws off of ISO 9001:2008,
"emphasizing defect prevention and the reduction of variation and waste in the supply chain."

The standard
ISO/TS 16949 applies to the design, development, production and, when relevant, installation and servicing of
automotive-related products. The requirements are intended to be applied throughout the supply chain, with vehicle
assembly plants being encouraged to seek ISO/TS 16949 certification so as to improve system and process quality,
to increase customer satisfaction, to identify problems and risks in production process and supply chain, and to take
preventive measures to ensure effectiveness.
The technical specification is organized as follows:

Introduction
This section introduces the perceived importance of quality management systems as well as adopting a process-based
approach to their development and implementation. It also addresses its relationship to the ISO 9001, 9004 and
14001 standards.

Scope
The scope and application of the standard is described as defining "the quality management system requirements for
the design and development, production and, when relevant, installation and service of automotive-related products."

Normative references
This section states the definitions in ISO 9000:2005 are vital to applying the specification.

Terms and definitions

Additional definitions like "control plan," "error proofing," and "laboratory scope" are defined.

Quality management system

The requirements for the operational effectiveness of a manufacturer's quality management system are outlined in
this section. The requirements are broken down into two subsections:
4.1 General requirements
4.2 Documentation requirements
ISO/TS 16949 124

Management responsibility
This section outlines the managerial responsibilities associated with designing and implementing a quality
management system. These responsibilities are broken into six subsections:
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review

Resource management
This section outlines the requirements for managing the various resources needed to develop and maintain a quality
management system as well as improve its effectiveness. These responsibilities are broken into four subsections:
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment

Product realization
The requirements for managing the aspects of a quality management system that directly affects how products are
designed, produced, and shipped are covered in this section, which spans six subsections:
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring equipment

Measurement, analysis and improvement

The requirements of this section address how products created through the quality management system should
conform and be continually assessed for improvement. This section is divided into five subsections:
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
ISO/TS 16949 125

Annex A
Annex A: Control plan "shows the correspondence between ISO 9001:2008 and ISO 14001:2004."

Certification
Manufacturers get ISO/TS 16949 certified based of the certification rules issued by the International Automotive
Task Force (IATF). Those certification rules changed in April 2014, "intended to strengthen the value of the
certification as seen by the customers of the scheme, i.e. the automotive OEMs who receive the products that are
produced by the suppliers certified to the scheme." The new rules place extra emphasis on customer-measured
performance as well as audit planning, including additional controls on site extensions, ring fencing, and
nonconformity management. In March 2014, standards institute BSI outlined all the changes that took place to the
certification process in their document Presentation by BSI on the main changes to the IATF ISO/TS 16949
certification scheme.
Certifications last three years, and according to the new rules, the first recertification audit should be completed
within exactly three years of the initial Stage 2 audit.

Further reading
Lomas, Frank (14 March 2014). "Presentation by BSI on the main changes to the IATF ISO/TS 16949
certification scheme" [1] (PDF). The British Standards Institution.

External links
ISO/TS 16949 standards at the International Organization for Standardization [2]

References
[1] http:/ / www. bsigroup. com/ LocalFiles/ en-US/ Documents/ TS16949changespresentations. pdf
[2] http:/ / www. iso. org/ iso/ catalogue_detail?csnumber=52844
The American Society of Crime Laboratory Directors/Laboratory Accreditation Board 126

The American Society of Crime Laboratory

Directors/Laboratory Accreditation Board
The American Society of Crime
Laboratory Directors/Laboratory
Accreditation Board (ASCLD/LAB)
is a Missouri-based not-for-profit that
"offers voluntary accreditation to
public and private crime laboratories"
around the world. Laboratories wishing
to become accredited must go through
a proficiency testing program as part of
the accreditation process.

The main objectives of the

ASCLD/LAB are:
1. to improve the quality of laboratory
services provided to the criminal More than 400 crime labs around the world have chosen to get accredited by the
ASCLD/LAB.
justice system.
2. to adopt, develop and maintain
criteria which may be used by a laboratory to assess its level of performance and to strengthen its operation.
3. to provide an independent, impartial, and objective system by which laboratories can benefit from a total
operational review.
4. to offer to the general public and to users of laboratory services a means of identifying those laboratories which
have demonstrated that they meet established standards.

History
The American Society of Crime Laboratory Directors (ASCLD) was officially founded in the fall of 1974. Around
the same time, a national examination of forensic science laboratories began, culminating in 1977 with the revelation
that many mistakes were being made in those labs. The problematic statistics that came out of that research partially
drove the ASCLD to create the Laboratory Accreditation Board (LAB) in the summer of 1981. The ASCLD/LAB
eventually incorporated as a non-profit corporation in Missouri on February 4, 1988. By June 1992, the organization
had accredited 128 laboratories, including its first international laboratory, located in Adelaide, Australia. By the
spring of 2014 that total was 403.

Accreditation
ASCLD/LAB accredits forensic laboratories and certain forensic breath alcohol calibration programs to help them
"demonstrate that its technical operations and overall management system meet ISO/IEC 17025:2005 requirements
and applicable ASCLD/LAB-International supplemental requirements." Application review, on-site assessments,
quality review, and, if necessary, corrective action resolutions are conducted before the final review and
accreditation decision. The International accreditation typically is good for four years as long as the lab remains
compliant and maintains obligations such as notification of significant changes to primary policies, resources,
organization, and legal ownership.
The American Society of Crime Laboratory Directors/Laboratory Accreditation Board 127

Compliance
After acceptance, ASCLD/LAB uses its Annual Accreditation Audit Report, proficiency testing reports, and
laboratory visits to monitor a crime lab's compliance with the body's accreditation standards. In the unusual case of a
laboratory failing to comply with those standards, the ASCLD may choose to place the lab on probation. Examples
of such probationary action include the Nassau County, New York crime lab in 2007 and 2010 and the El Paso
Police Department in 2011. Once on probation, the affected lab must satisfy certain conditions before being able to
again operate and eventually be removed from the probationary period, including but not limited to submitting lab
analyses for external technical reviews. In extreme cases of non-compliance, the ASCLD can also choose to suspend
the lab for a period of time or even revoke the lab's accreditation.

External links
ASCLD [1]
ASCLD/LAB [2]

References
[1] http:/ / www. ascld. org/
[2] http:/ / www. ascld-lab. org/

The NELAC Institute

The NELAC Institute (TNI) is a non-profit organization dedicated to promoting "the generation of environmental
data of known and documented quality through an open, inclusive, and transparent process that is responsive to the
needs of the community." The founders' long-term motivation behind the creation of the NIC was to enact a
"uniform, rigorous, and robust" nationwide environmental laboratory and monitoring accreditation program. This
accreditation program exists today in the form of the National Environmental Laboratory Accreditation Program
(NELAP).

History
The NELAC Institute (TNI) was formed on November 6, 2006 as a collaboration between the National
Environmental Laboratory Accreditation Conference (NELAC) and the Institute for National Environmental
Laboratory Accreditation (INELA) with "the vision that all entities generating environmental data in the United
States be accredited to a national standard."
With the original 2003 NELAC Standard and 2005 updates to ISO/IEC 17025 as their guide, TNI continued work on
revising the NELAC Standard, culminating in the release of its new standards in July 2011. The revisions both made
ISO/IEC 17025 adherence mandatory and added analysis requirements for "five new contaminants and lower limits
for existing contaminants."

National Environmental Laboratory Accreditation Program

NELAP is an accreditation program targeted at environmental laboratories. The laboratory and accreditation body
standards for the program are modeled after sections of ISO/IEC 17025 and ISO/IEC 17011. Accreditation for
NELAP is performed by U.S. state governmental agencies that wish to participate; control over scope, laboratory
types accepted, and fees are all controlled by the state agency. As of February 2015[1], 14 agencies in 13 states are
organized as NELAP accreditation bodies. Those states are Florida, Illinois, Kansas, Louisiana, Minnesota, New
Hampshire, New Jersey, New York, Oregon, Pennsylvania, Texas, Utah, and Virginia. California used to also
The NELAC Institute 128

participate but withdrew from the program on January 31, 2014.

Environmental laboratories seeking NELAP accreditation are directed to go to their State's accreditation body. If the
lab's state doesn't have such a body, the lab is still able to select an out-of-state body to do the accreditation for them.
This sort of "reciprocal certification" has the disadvantage that the accredited lab will only be certified to test a
certain subset of analytes and contaminants, specifically those chosen for coverage by the state's accreditation body.
This requires labs to carefully select which state agency to go through. Once the application stage begins, labs go
through a series of performance evaluation studies and on-site auditing as well as pay the necessary fees. Each state
may vary its audit requirements for labs maintaining accreditation.

External links
The NELAC Institute [2]
National Environmental Laboratory Accreditation Program [3]
TNI LAMS [4]

References
[1] http:/ / limswiki. org/ index. php?title=The_NELAC_Institute& action=edit
[2] http:/ / www. nelac-institute. org/ index. php
[3] http:/ / www. nelac-institute. org/ newnelap. php
[4] http:/ / lams. nelac-institute. org/
 129

7. Laboratory Informatics Resources

Laboratory, Scientific, and Health Informatics

Buyer's Guide
This buyer's guide is based off the LIMS Buyer's Guide, a former
publication of the Laboratory Informatics Institute (LII), an open trade
association associated with LabLynx, Inc. In late 2013, the LII and
LabLynx discontinued publishing a copyrighted version and chose to
release future guides to the public domain via this wiki. Per the
Creative Commons license [1] and the copyright terms of this site, you
are free to copy, adapt, distribute, and transmit this guide as long as
you 1. give proper attribution and 2. distribute the work only under the
same or a similar license.

About this guide

What exactly is a laboratory information management system (LIMS)
or laboratory information system (LIS) anyway? Do I need one? What
options are available and how do I compare them? What about a
request for information (RFI), request for proposal (RFP), or request
for quotation (RFQ)? These are questions laboratory professionals
typically ponder upon finding themselves charged with the mission of finding software for their lab. It can be a
daunting proposition, and there doesn't seem to be any objective reference to help with it all. This guide hopes to
change that.

For this free public domain version of the guide, we've added more vendors, updated new information, and added
links to video demonstrations of their systems, with the goal of providing the accurate information you need to make
decisions for your lab. This guide also strives to be different from any buyer's guide that has ever come before by
including pricing. For the first time you have real information as well as pricing so you can quickly pursue only the
vendors and products that make sense for you and your lab. While in the past vendors have refrained from providing
public pricing, the trend is arguably changing towards a more open information process, though not without its own
set of caveats. In theory, that means prices should decrease as LIMS become commodities that labs can compare and
contrast in a more competitive fashion.
At the core all labs are in the business of producing reports, data... essentially information. Everything else is just a
means to that central goal. So in a very real sense, information management is the core of any lab. In a world where
we use the latest technology for most of our daily tasks and pleasures, why do so many labs still rely on hand-written
notes and spreadsheets? Spend thousands of dollars on a sophisticated analytical instrument yet hesitate when faced
with purchasing an information management system? Why? The primary reason is price priorities.
Since LIMS are increasingly becoming commodities, driving down prices, potential buyers don't need to make the
tough decision of one or the other anymore. As technology has improved, smaller LIMS companies have emerged,
along with affordable SaaS online subscription models that are trustworthy. This means any lab can put their
resources where they belong: in information and its management.
Laboratory, Scientific, and Health Informatics Buyer's Guide 130

Notes about the content

The LIMS Buyers Guide is here to help you wade through the mire. Use the information and vendor profiles to get a
feel for what's out there and what makes the most sense. This guide contains information on everything from "what
is a LIMS?" to maintaining and supporting your system. Additionally, whether you call it a LIMS, LIS, or even a
LMS, in the end it's simply a tool to better manage your lab's data. This guide will refer to it all as LIMS for the
sake of simplicity and consistency, though this guide may include systems officially dubbed as a LIS or ELN.
Finally, a primary criterion for inclusion in this guide is publicly available pricing information that can thusly be
cited. If citeable public pricing is not available, the vendor will not be listed in this guide. Any inappropriate
additions will be removed.

How do I find the right LIMS, and how much will it cost?
To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.
OK, LIMS are getting more affordable, but where do you start? You may know the needs of your lab and how it
runs, but perhaps you don't know LIMS and are intimidated by all the options. Take heart! This guide features a
compiled list of major and minor players to help you make initial comparisons. However, you'll first need to gauge
your lab's informatics needs in order to determine which products are worth investigating further. Of course your
lab's analysis requirements, reporting and data sharing constraints, instrument interfacing, barcoding needs, quality
assurance processes, etc. are very important factors. But LIMS vary in numerous ways, and other important factors
exist. Price should certainly be considered, although value is ultimately more important than a low price. Other
important considerations:
Should we purchase licenses or "rent" them via subscription?
Does the software need to be on-site, or is a SaaS hosted option more practical?
Is a modular or complete system better for us?
What is the best licensing/rental scheme for us? Show we consider site, named user, concurrent user, or
workstation licenses?
Is the company qualified and trustworthy?

Purchase vs. subscribe

In the past this was not an option. But much like the recent trend toward leasing cars rather than finding a large
amount of money for up-front purchasing, labs can choose to pay only the cost of services (setup, training, report
configuration, instrument interfaces, data migration, custom functions, etc.) and get started on a monthly subscription
rather than buy licenses outright. When does this make sense? Subscriptions make sense primarily:
...if a large lump sum is hard to get budgeted. If your business cash flow will support the regular subscription fee
but finding license fees is more problematic, then a subscription may be right for you. But do the math. Calculate
project costs over a reasonable period (e.g. five years) to make sure it is a value proposition. Be sure to include
maintenance and support in your figures; this is often included in a subscription but not in a license.
...if you may need to reduce the number of users. Once you buy licenses, they are yours. You can't "un-buy" them.
But with a subscription you can raise and lower the number of users, workstations, etc. as you need to.
...if you may need to bail. Business decisions often need to be dynamic. Your lab may decide to go into another
area of analysis, and if your LIMS isn't versatile enough to support the change, you have potentially wasted a lot
of money.
On the other hand, it may be important to you to have the LIMS source code. Some subscriptions allow you just as
much access to it as if you had purchased licenses, while others may not give you the access you seek. Confirm this
with the vendor. Alos, ask whether you get to keep an image of the database should you decide to end your
subscription.
Laboratory, Scientific, and Health Informatics Buyer's Guide 131

Onsite vs. SaaS

A small but growing number of LIMS vendors will actually host your system on their servers for you or cloud-host it
elsewhere. We refer to software accessed via the Internet rather than your workstation or server as software as a
service or SaaS. Most of us already make copious use of SaaS whenever we "Google" something. Cloudhosted SaaS
is characterized by multiple load-balanced servers that allow resources to be strategically used, and virtualized
servers that allow for the creation of custom environments.To decide if SaaS is for you or if you should go the
traditional route, here are some points to consider:
If you have a small or overworked IT department, or none at all, then it may make sense to let the LIMS provider
take care of those functions rather than invest in additional hardware, personnel, and other resources just to
support your LIMS. If you are a large company with an extensive and capable IT department, then you may prefer
the LIMS and its database to reside on premises.
IT techs cite security as a major reason to keep a LIMS on lab premises. The truth is, if the vendor uses a SAS-70
or SAS 70 Type II data center to host, with GxP SOPs, your system and data are probably a lot safer than on a
typical business infrastructure. Ask the vendor.
If you decide to have your system hosted, ensure it's not by Bob and his buddy in their basement. The vendor
needs to have been around awhile, have solid references, and feature good customer service.
A reputable SaaS host will guarantee you high availability, approaching 100% up time, with quick and responsive
catastrophe response. Redundant components and infrastructure (power, cooling, etc.) allow them to do that.

Modular vs. complete

Some LIMS are offered as a collection of modules for you to select from to constitute your completed system, while
others come complete with all the functionality available. Those whose LIMS are modular espouse the benefit of
only paying for the functionality you need. Those whose LIMS come as a complete package say labs won't need to
pay extra for any add-ons. Who's right? Well, it depends. If buying modules means you need one module for sample
tracking and another for data entry, and still another to generate reports, then it may not be long before you run up a
sizable bill just to get basic standard functionality, especially if the modules require hourly services to implement. If
the modules tend to be industry-specific and complete, then they may make sense. Make sure you compare your
needs with the product functionality and identify all costs associated with getting everything you need out of the
software.

Named users vs. concurrent users

When comparing license fees, understand the difference between named users and concurrent users. If a vendor
charges by named users, and your lab will have 30 people who will use the LIMS at any time, you will need 30
licenses. If the vendor charges by concurrent users, then you only need enough licenses to cover the number of users
who are likely to be on the system at the same time. Typically in a lab with 30 staff, you might need a maximum of
20 concurrent user licenses. This is reduced even further if you have sites in other parts of the world whose work
days differ.

The company
As important as the LIMS and its functions are to you, the company is at least as important. Make no mistake: this is
a relationship you are entering into. This is not like selecting a piece of furniture. A LIMS is like a living, dynamic
entity, and you'll need to interact with the vendor from time to time even with the most trouble-free system. Of
course that interaction will be particularly intense in the beginning as they provide installation, provisioning,
training, and other set-up services. Take your cue from your initial dealings with them. Just like in any relationship,
they will be presenting their best side to you then. If the vendor return calls or emails late or fails to follow through
with what they say they'll do, then you can bet it will be much worse once you are their customer. So yes, do the
Laboratory, Scientific, and Health Informatics Buyer's Guide 132

usual: research their years in business, size, staff qualifications, references, etc., but also ask yourself if you would be
comfortable doing business with the vendor in the long term.

The functionality
And now we come to what probably has weighed most on your mind since you had the first idea you might need a
LIMS: functions and features. The functionality of the LIMS is paramount, so it is important you first have an idea
of what a LIMS can do, and then you can begin to decide which functions and features you need or want.

Core functions and features

You should expect the following functions to be demonstrated in a full-function LIMS:
audit trail
barcoding
batching
chain of custody
configurable setup
data entry
data warehousing and mining
document management
electronic data exchange
data warehousing and mining
event-driven actions
fax and email integration
formulas
instrument interfacing, calibration, and maintenance
inventory
login and accessioning
multiple location/department support
regulatory compliance
reporting
review and approval
sample management and tracking
scheduling
training tracking
trending and control charting
version control
workload management
workflow management
Laboratory, Scientific, and Health Informatics Buyer's Guide 133

Additional useful features

The following functions aren't necessary for all but useful for many:
case management
complaints and corrective actions
customer relationship management
electronic laboratory notebook
ERP and accounting interfaces
invoicing
product specification management
project management
RFID
quoting
safety tracking and compliance
supervisory control and data acquisition (SCADA) interfacing
stability management
web client or portal

How much will it cost?

OK, now you understand what to look for in a company and its products. What you likely don't yet know: the price
tag. Heck, most of us don't even know how LIMS vendors price their products or what is involved, much less how
much they actually cost. In truth, there are three vital pricing components for any LIMS:
1. licenses
2. subscriptions
3. services
The software itself never comprises the entire cost. LIMS are complex creatures, and your lab, even if it's small, is
fairly complex, too. Let's go over what's involved and how much it's roughly going to cost.

Licenses
If the software has a purchased license type (as opposed to rented/subscription), then you will of course have to pay
for those. Keep in mind what we said earlier about named vs. concurrent user pricing. Other methods include by site,
by CPU or server, by workstation, or by unlimited user corporate level licensing. Arguably the lack of
standardization in this area has contributed as much as anything to the vagueness that has surrounded LIMS pricing
for so long. The linked vendor profiles in the next section feature pricing information for licenses for the included
vendors. (Remember: the primary criterion for inclusion is publicly available pricing.) Review and compare, but
make sure you factor in pricing method.

Subscriptions
These include two possible items:
1. rented or SaaS LIMS
2. annual maintenance, support, and warranty (MSW)
The cost of LIMS rental is equivalent to the licensed type, but a lump sum up front is not required. These can run
anywhere from a couple of hundred dollars a month for a single user up to maybe $2000 or so for 20+ users. Just like
purchased licenses, however, these can be priced by site, concurrent or named users, etc., so make sure you compare
like with like or at least factor these considerations in as you shop. And your rental may be annual instead of
monthly. In most cases it does include all IT services and maintenance, support, and warranty, including updates, at a
specified level.
Laboratory, Scientific, and Health Informatics Buyer's Guide 134

The second type of subscription cost is annual MSW, and you need to factor that into your budgeting if you are
buying LIMS licenses. Typically it is priced at around 15 percent of the license fee and is available at graduated
levels. A certain level may be standard for a certain number of licenses (for example, 10 hours of support and
additional services available at $200 per hour for a 10-concurrent user LIMS), but you can buy a higher level of
support and cheaper rate for additional services if you want to pay extra. One thing to keep in mind: with an MSW
you will certainly need coverage as you go through your first year. If you think you can then drop it, think again. A
modern LIMS should be built on technology that can give it a much longer life span than those in years past. That is
dependent on staying updated. If you lose that update path, your LIMS will expire prematurely. If you decide later to
renew MSW, you may find yourself liable for the missed years before the vendor will bring you current.

Services
Your LIMS is a function of the cost of the LIMS itself plus the services involved in its implementation plus, in the
case of a licensed LIMS, annual MSW. Many first-time LIMS buyers neglect to factor in the cost of services when
budgeting. As mentioned earlier, any LIMS will require services to get going, and you may want more if there are
extras you need or want. Services break down more or less like this:
Basic implementation services
kickoff meeting (planning, coordination, communication procedures, etc.)
training
setup (enter users, configure profiles, departments, tests, screens, etc.)
create main report(s)
go live support
Additional or optional services
instrument interfaces
additional reports
data migration from a previous system
interfaces to other systems or databases
special customizations
web portal configuration
validation
standards certification support
You may need other services. Rates for services vary from vendor to vendor, but a good rule of thumb for initial
budgeting purposes is to figure service costs to be roughly equal to the licensing cost or to a year's worth of LIMS
subscription.

Commercial vendors with public pricing

To hide the contents of this section for easier reading of other sections, click the "Collapse" link to the right.

For free open-source laboratory informatics software, please see the open-source laboratory informatics software page.

Click the link of each vendor to find useful product information, pricing information, and demo videos.
Laboratory, Scientific, and Health Informatics Buyer's Guide 135

Vendor Has cloud or # of LIMS? LIS? ELN? SDMS? Additional notes

SaaS demo
offering? videos

LabLynx, Inc. Yes 38 Yes No No No

SLCLAB Informtica SL Yes 38 No Yes No No

Two Fold Software Limited No 32 Yes No No No

BioData Inc. Yes 28 Yes No No No

Scilligence Corporation Yes 23 No No Yes No Prices for self-hosted ELN Enterprise edition are not
publicly available.

labfolder GmbH Yes 21 No No Yes No

Laucks Technical Services, No 19 Yes No No No

LLC

LabArchives, LLC Yes 18 No No Yes No Pricing only available for non-profit entities;
for-profit prices not public.

LabLite, LLC No 16 Yes No No No

Autoscribe Ltd. No 13 Yes No No No

Research Innovations Limited Yes 12 No No Yes No

Biomatters Ltd. No 10 Yes No No No

eBioSys Pty. Ltd. No 9 Yes No No No

Thermo Scientific No 9 Yes No No No Public pricing for Darwin and Galileo unavailable at
this time.

AgileBio No 8 Yes No No No

Mestrelab Research S.L. Yes 8 No No Yes No

LabVantage Solutions, Inc. Yes 6 Yes No Yes No

Agilent Technologies, Inc. No 5 No No Yes No

Instrumentos Cientficos SA Yes 5 Yes No No No

BiochemLab Solutions No 4 No No Yes No Free ad-based and paid ad-free versions of ELN exist.

NoteBookMaker, LLC Yes 4 No No Yes No

Sysment Kft. No 4 No No Yes No

The Edge Software Yes 3 Yes No Yes No

Consultancy Ltd.

BioSistemika LLC Yes 2 No No Yes No

LABTrack, LLC Yes 2 No No Yes No

Blaze Systems Corporation No 1 Yes No No No

ChemWare, Inc. No 1 Yes No No No

CloudLIMS.com, LLC No 1 Yes No No No

Dynamic Databases, LLC No 1 Yes No No No

EZQuant Ltd. No 1 No No Yes No

LabWare, Inc. No 1 Yes Yes No No LIMS software with additional LIS-like functionality

Promium, LLC Yes 1 Yes No No No

STARLIMS Corporation No 1 Yes No Yes No Pricing only available for LIMS, not ELN.
Laboratory, Scientific, and Health Informatics Buyer's Guide 136

ChemBytes No 0 No No Yes No

Findings Software SAS No 0 No No Yes No

FORMULATOR Software, No 0 No No Yes No

LLC

Genetic Technologies, Inc. No 0 Yes No No No

Mountain States Consulting, No 0 Yes No No No

LLC

Nippon Control System Yes 0 Yes No No No

Corporation

shazino SAS Yes 0 No No Yes No

SPLhost, Inc. Yes 0 No No Yes No

Summit Research Services No 0 Yes No No No

Terra Systems O No 0 No Yes No No Pricing only available for MiniLIS, not other
products.

Additional resources and help

Lab Careers
Lab Careers [2] is a LinkedIn-associated group for the viewing and posting of job openings for laboratory, scientific,
and health lab careers.

LIMS Forum
LIMS Forum [3] is a LinkedIn-associated group for those interested in laboratory, scientific, and health informatics.

LIMS University
LIMS University [4] is a free and open-access learning and teaching resource for those wanting to learn more about
laboratory informatics or LabLynx's ELab system.

LIMSfinder
LIMSfinder [5] is a web portal for those looking for a LIMS and related information, services, products, news,
events, resources, jobs, etc.

LIMSpec
LIMSpec [6] (.zip file) is a collection of templates from lab requirements assessment to LIMS vendor and system
questionnaires, validation documents, and more for identifying LIMS needs and matching them with what's out
there. It's complete with instructions and examples to help guide you through the process.
Laboratory, Scientific, and Health Informatics Buyer's Guide 137

LIMSwiki informatics resource portal

The informatics resource portal here at LIMSwiki features a collection of as many useful online scientific and health
informatics-related materials and research tools as possible, including books, journals, blogs, web portals, education
programs, conferences, and more.

External links
original LIMS Buyer's Guide page [7]

References
[1] http:/ / creativecommons. org/ licenses/ by-sa/ 3. 0/
[2] http:/ / www. labcareers. com
[3] http:/ / www. limsforum. com
[4] http:/ / www. limsuniversity. com/
[5] http:/ / www. limsfinder. com/
[6] http:/ / files. limstitute. com/ share/ limstitute/ downloadlimspec. zip
[7] http:/ / limsbook. com/

Open-source laboratory informatics software

This page exists as a complement to the category page Category:Laboratory informatics software (open source).
Because category pages do not render in the book creator plug-in for this wiki, a separate page has been created to
list the contents of the category page.
Last updated January 7, 2016.
A

AdLIMS

BASE
Bika LIMS
BonsaiLIMS

C4G BLIS
Caisis
Care2X
ClearHealth
ClinCapture
CyNote

Dcm4che2
Dicoogle

ELabFTW
Electronic Laboratory Notebook (PNNL software)
Open-source laboratory informatics software 138

Eln

Free D Path

Galaxy (biomedical software)

GNomEx
GNU Health
GNU LIMS

Indigo ELN
IPath
ITK

JuliaBase

KNIME

LabKey Server
LabStoRe
LabTrove
LabWiki
LAMA
LIIS

Mirth Connect
MISO
MolabIS
Ms-lims

Open enventory
Open Laboratory Framework
Open-LIMS
OpenBIS
OpenCDMS
OpenChrom
OpenClinic GA
OpenClinica
OpenCryobank
OpenELIS
Open-source laboratory informatics software 139

OpenEpi
OpenFreezer
OpenMEDIS
OpenMRS
OpenSpecimen
OpenVista
OsiriX

PHYAURA EHR
PiMS
ProtLIMS

Sample Inventory Program

SciTran
Screensaver HTS LIMS
SeqWare
Sesame LIMS
SIGLa
SMITH

Laboratory informatics consultants

Click here to return to the LIMSWiki:Resources page for all available informatics resources.

About this list

While this arguably may not be an authoritative list of consultancies relating to laboratory and scientific informatics,
an attempt has been made to make it thorough.

LIMS, LIS, and laboratory

These consultancies seem to focus primarily on helping others plan, choose, and implement an informatics system
for the laboratory, though they may offer other services to laboratories such as computer system validation (CSV).
(The location represents the entity's headquarters.):
Laboratory informatics consultants 140

Vendor Headquarters Key services Services

page

[1] Fairfield, IL, U.S. "We provide project management, system development,
A Byte of Advice, Inc. Services
code modification, support and training"; experience with page [1]
LabVantage and PerkinElmer products

ABB Ltd. Zurich, Switzerland Provides an expansive set of services. Services

[2]
page

Edison, NJ, U.S. "Astrixs core competency is to assist organizations in the Services
Astrix Software Technology, Inc. dba Astrix
[3] development and implementation of data management [4]
Technology Group page
strategies to enhance the collection, processing, analysis
and reporting of scientific data."

[5] Atlanta, GA, U.S. Provides a wide range of services, particularly with SCC
Atlanta Consultant Services
and Cerner products [4]
page

BGASoft, Inc. dba LIMS ABC Fort Lauderdale, Business analysis, lab process improvement, enterprise Services
FL, U.S. and cloud architecture, LIMS implementation, etc. [6]
page

Bika Lab Systems (Pty) Ltd. Western Cape, LIMS requirement analysis, design, customization, Services
South Africa configuration, and testing; training; project management, [7]
page
etc.

[8] Endwell, NY, U.S. Labware products, user requirements specifications,

Bottom Line Consulting, LLC Services
vendor selection, project management [8]
page

[9] Sacramento, CA, Labware products, LIMS implementation; project

Brevitas Consulting, Inc. Services
U.S. management; quality assurance, etc. [10]
page

Chemtech Servicos de Engenharia e Software Ltda. Rio de Janeiro, Manufacturing execution systems, SCADA, automation, Services
[11] Brazil cyber security, etc. [12]
page

[13] Carmel, IN, U.S. Provides a wide range of services "to all types of clinical
Clinical Lab Consulting, LLC Services
laboratories including governmental, academia, [14]
page
hospital, reference and physician office laboratories."

Marietta, GA, U.S. "Medical Source offers experience, guidance, and

Clinical Laboratory Consultants dba Medical Services
[15] unmatched expertise in the physician office and [16]
Source page
independent
reference laboratory."

Cosine Consultants Ltd. Strovolos, Cyprus Software customization, data management system Services
consulting, Fission LIMS, etc. [17]
page

[18] Wayne, PA, U.S. Computer system validation, FDA compliance, LIMS,
Covex, LLC Services
system and network management, engineering, etc. [19]
page

CSols, Inc. Newark, DE, U.S. Laboratory informatics strategic services, ELN and LIMS Services
implementation, computer system validation, and [20]
page
laboratory vendor-specific technologies

[21] Zurich, Switzerland Information technology, engineering, clinical data

Edelway AG Services
management, regulatory affairs and compliance, etc. [21]
page
Laboratory informatics consultants 141

[22] Kibworth Harcourt, "We deliver the knowledge and expertise regarding
Feltham Associates, Ltd. Services
U.K. information needs, laboratory and radiology computer [23]
page
systems applications and the supporting infrastructure."

[24] Chicago, IL, U.S. Laboratory informatics, Open-LIMS

ForwardPhase Technologies, LLC Services
[25]
page

[26] Paris, France eLearning tools, clinical trial management systems,

Fructeam SARL Services
LIMS, ELN, SDMS, SAP [26]
page

[27] Ann Arbor, MI, "GeoMetrick Enterprises has solved LIMS problems for
GeoMetrick Enterprises Services
U.S. large and small companies in wide array of industries." [28]
page

[29] Pacifica, CA, U.S. LIMS selection, implementation, and change

HPFM, Inc. Services
management; computer system validation; quality [29]
page
management systems, etc.

[30] San Francisco, CA, LIMS implementation and validation; computer system
iConnect Consulting, Inc. Services
U.S. validation; HL7 electronic communication, training [30]
page

[31] Filderstadt, LIMS selection and implementation, computer system

IMCOR GmbH Services
Germany validation, business process analysis and optimization [32]
page

[33] Swedesboro, NJ, Laboratory informatics, LIMS, validation, environmental

J & R Consulting, Inc. Services
U.S. monitoring, implementation, customization, etc. [33]
page

[34] Weymouth, MA, Healthcare management, LIS pre-implementation

KPMG LLP Services
U.S. assessment and planning, system optimization, etc. [35]
(formerly Beacon Partners, Inc.) page

[36] Sugar Land, TX, Laboratory informatics, LIMS, LIS, ELN, data analytics,
LabAnswer, Inc. Services
U.S. managed services, etc. [37]
page

[38] Cambridge, MA, Laboratory informatics, LIMS, LIS, ELN, project

LabCentrix, LLC Services
U.S. management, data migration, computer system validation, page [39]
etc.

[40] Ishpeming, MI, Laboratory informatics, automation, instrumentation,

LabMetrics, LLC Services
U.S. compliance and auditing, quality assurance, etc. [41]
page

[42] McAllen, TX, U.S. Clinical laboratory informatics, LIS, quality assurance,
Laboratory Advisory Bureau, LLC Services
compliance and auditing, workflow management, etc. [43]
page

[44] Celbridge, Ireland Laboratory and scientific informatics, 21 CFR Part 11,
Laboratory Systems Consulting Services
project management, etc. [45]
page

[46] New York, NY, Laboratory informatics, compliance management, quality

LisWalter Consulting Services
U.S. management, procedure development, training, etc. [47]
page

[48] La Paz, Bolivia Laboratory informatics, geological and geotechnical

LIMS Consultant Engineers Ltd. Services
engineering, data validation, etc. [49]
page

[50] Vienna, Austria Laboratory informatics, LIMS, ELN, CDMS, document

LIMSCON Services
management, training, project management, [50]
page
computer system validation, etc.

[51] Barcelona, Spain Laboratory informatics, LIMS, data migration, laboratory

NARALABS, S.L. Services
workflow, system evaluation and [52]
page
implementation, quality assurance, etc.

[53] York Harbor, ME, Clinical laboratory informatics; system assessment,

Nichols Management Group Ltd. Services
U.S. implementation, and integration; [54]
page
project management; workflow management, etc.
Laboratory informatics consultants 142

[55] Chennai, India Laboratory informatics, LIMS, testing and validation,

NXG Group, Inc. Services
system integration management, business consulting, etc. [56]
page

[57] Dublin, Ireland Laboratory informatics, LIMS, quality assurance, system

Orbis Labsystems Ltd. Services
integration management, automation, etc. [58]
page

[59] Kennebunk, ME, "Project Management, Software Quality, and

Q2Marketsite, LLC Services
U.S. FDA-regulated validation services for pharmaceuticals, [60]
page
medical devices, biologics, and biotech organizations"

[61] Oslo, Norway Laboratory informatics, LIMS, CDMS, 21 CFR Part 11,
Segalstad Consulting AS Services
computer system validation, quality management, etc. [62]
page

[63] Wrrstadt, Laboratory informatics, LIMS, custom development,

up to data professional services GmbH Services
Germany Thermo Scientific products, etc. [64]
page

[65] Palo Alto, CA, U.S. Laboratory informatics, microbiological and chemistry
Validation Systems, Inc. Services
services, quality management systems, [65]
page
computer system validation, etc.

[66] Suffolk, U.K. Laboratory informatics, automation, system integration,

WynnIT Ltd. Services
user requirement specifications, [67]
page
custom development, etc.

General laboratory
These consultancies offer general help to laboratories, including management and quality control among other things
(location represents headquarters):

Vendor Headquarters Key services Services page

[68] Aubrey, TX, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection

A & J Laboratory Consultants Services page
correction, workflow improvement, training, etc. [69]

[70] St. Louis, MO, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection
AMS Medical Laboratories Services page
correction, workflow improvement, [71]
profitability analysis, procedure development, etc.

[72] San Diego, CA, Laboratory start-up, pre-inspection evaluation, post-inspection

Ancillary Medical Solutions Services page
U.S. correction, workflow improvement, [73]
staffing, procedure development, etc.

Burlington, MA, Laboratory start-up and consolidation, LIS, automation, workflow

Applied Management Systems, Inc. Services page
[74] U.S. improvement, hospital productivity and management, [75]
quality assessment, etc.

Franklin Lakes, NJ, Laboratory start-up and consolidation, preanalytical best practices
Becton, Dickinson and Company Services page
[76] U.S. training, etc. [77]

[78] Kansas City, MO, Laboratory design and development

Black & Veatch Corporation Services page
U.S. [79]

Arvada, CO, U.S. Laboratory start-up, workflow improvement, procedure development,

BP Laboratory Consulting, LLC Services page
[80] training, regulatory compliance, etc. [81]

Dallas, TX, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection

C&C Clinical Laboratory Services page
[82] correction, workflow improvement, [83]
Consulting, LLC
quality management, procedure development, etc.

[84] Austin, TX, U.S. Laboratory start-up, regulatory compliance, workflow improvement,
Catalyst Consulting Services page
profitability analysis [85]
Laboratory informatics consultants 143

[86] Ann Arbor, MI, Laboratory design and start-up, laboratory implementation and
Chi Solutions, Inc. Services page
U.S. management planning, anatomical pathology services, [87]
quality assessment, etc.

[88] Tampa, FL, U.S. Laboratory design and start-up, laboratory implementation and
Colaborate, LLC Services page
management planning, laboratory informatics, [89]
performance analysis, etc.

[90] Southfield, MI, U.S. Emphasis on forensic science, laboratory design and planning,
Crime Lab Design Services page
feasibility studies, civil and mechanical [91]
engineering, workflow management, etc.

[92] South Windsor, CT, Laboratory start-up, pre-inspection evaluation, post-inspection

CT POL Consultants Services page
U.S. correction, workflow improvement, LIS, EHR, [93]
lab billing, procedure development, etc.

Newnan, GA, U.S. Laboratory design and start-up, pre-inspection evaluation,

Diversified Laboratory Sciences, Services page
[94] post-inspection correction, workflow improvement, [95]
Inc.
risk assessments, etc.

[96] Knoxville, TN, U.S. Laboratory and physician practice accounting, compliance,
DoctorsManagement Services page
development, and operation improvement [96]

[97] Puteaux, France Laboratory operations, billing and reimbursement, regulatory

ELITech Group SAS Services page
assistance, profitability analysis [98]

[99] Garden Grove, CA, Laboratory start-up, laboratory operations, regulatory assistance
Gnosis International, LLC Services page
U.S. [100]

[101] Cleveland, TX, U.S. Pre-inspection evaluation, quality management, regulatory

Harrison Consultant Services page
compliance, [102]
procedure development, technical writing, etc.

[103] Torrence, CA, U.S. Laboratory start-up, pre-inspection evaluation, post-inspection

K&K Consultant Group, Inc. Services page
correction, workflow improvement, [104]
training, procedure development, etc.

[105] Burr Ridge, IL, U.S. Laboratory, science, and research building design and renovation
Ketchmark & Associates, Inc. Services page
[106]

[107] Abilene, TX, U.S. Data management, quality managementm, regulatory guidance,
Lab Advisory Bureau Services page
training, accreditation prep [108]

[109] Calabasas, CA, U.S. Compliance management, workflow improvement, training, procedure Services page
Lab IQ, LLC
development, feasibility studies, etc. [109]

[110] Napa, CA, U.S. Laboratory, science, and research building design and renovation;
Laboratory by Design, Inc. Services page
project management and administration [111]

Raleigh, NC, U.S. Laboratory start-up, consulting, and staffing; systems selection and
Laboratory Start-Up Consultants Services page
[112] validation; feasibility studies, standard [112]
operating procedure development, etc.

[113] Houston, TX, U.S. Laboratory audit preparation, corrective and preventative action
Labtopia, Inc. Services page
programs, quality assurance, [114]
project management, regulatory requirements, technical writing, etc.

[115] Carlsbad, CA, U.S. Laboratory audit preparation, DoD accreditation, litigation support,
LDC, Inc. Services page
data validation, training [116]

Philadelphia, PA, Laboratory start-up, regulatory requirements, training, process

Narayan Laboratory Consulting Services page
[117] U.S. development, pre- and post-inspection guidance, [118]
Services, Inc.
quality management, inspection readiness
Laboratory informatics consultants 144

OnTarget Consulting Services, LLC Atlanta, GA, U.S. Accreditation prep, operational and risk assessment, training, process Services page
[119] management [120]

[121] Oklahoma City, Application processing, staffing, training, workflow management,

Medical Lab Consulting Services page
OK, U.S. inspection preparation [122]

[123] Conshohocken, PA, Pathology laboratory design, start-up, and management; systems
Lab Solutions, Inc. Services page
U.S. selection and validation; [124]
inspection preparation; technical writing; staff evaluation and
competency development; etc.

Jackson, TN, U.S. Laboratory CLIA compliance, regulatory review, and inspection
Physicians Office Consulting, LLC Services page
[125] services; laboratory start-up and development [126]

[127] FL and NJ, U.S. Regulatory compliance, review, and inspection services; training
POC Consultants, LLC Services page
[128]

[129] Escondido, CA, Laboratory design and start-up, corrective action management,
Polestar Labs Services page
U.S. profitability analysis, instrument management [129]

Beverly, MA, U.S. Laboratory program development, laboratory design and start-up,
Quality Systems and Compliance, Services page
[130] pre-inspection evaluation, post-inspection correction, [131]
Inc.
workflow improvement, quality assurance, point-of-care testing
assistance, etc.

[132] Basalt, CO, U.S. Laboratory program assessment and enhancement, laboratory
Rodric Consulting, LLC Services page
restructuring and consolidation, compliance assessment, [133]
LIS implementation, CLIA and accreditation assistance, etc.

[134] Corona, CA, U.S. Laboratory compliance, maintenance, and benchmarking programs;
rpl Laboratory Solutions, Inc. Services page
feasibility analysis; technical writing; [135]
laboratory informatics project management; LIS; EHR; safety
services; etc.

Scituate, MA, U.S. Genetic testing laboratory experience; laboratory licensing,

South Shore Laboratory Services page
[136] compliance, and accreditation; quality assurance; [136]
Consultants, Inc.
laboratory start-up and management; equipment evaluation and
validation; etc.

Los Angeles, CA, Laboratory program assessment and enhancement, instrument

Strategic Directions International, Services page
[137] U.S. implementation, situation and opportunity analysis [138]
Inc.

N. Chili, NY, U.S. Microbiology and pharmacology laboratory experience, laboratory

The Microbiology Network, Inc. Services page
[139] regulation and auditing, laboratory process improvement, [136]
quality assurance, contamination control, aseptic processing, etc.

Laboratory design
These consultancies offer specific help to laboratories in the field of design and organization of a laboratory (location
represents headquarters):
Laboratory informatics consultants 145

Vendor Headquarters Key services Services page

[140] Carlsbad, CA, U.S. Laboratory design

Design for Science, LLC Services page
[140]

[141] San Francisco, CA, Laboratory design, laboratory renovation

GL Planning & Design, Inc. Services page
U.S. [142]

[143] Medina, OH, U.S. Laboratory design, laboratory renovation

In Office Labs Services page
[144]

[145] Pasadena, CA, U.S. Laboratory design, benchmarking, and workflow; vivarium design
Jacobs Consultancy, Inc. Services page
[146]

British Columbia, Laboratory design, refinery design, software system evaluation,

jsAnalytical Laboratory Consultants Services page
[147] Canada training [148]
Ltd.

[149] Santa Rosa, CA, U.S. Laboratory design, feasibility studies, test menu development,
Knapp-Frazer Consulting Services page
instrument evaluation, [150]
licensing and accreditation, technical writing

[151] Cheshire, U.K. Laboratory design, feasibility studies, project management

Komoly Associates Services page
[152]

Budford, GA, U.S. Laboratory design, renovation, and relocation

Laboratory Design and Supply, Inc. Services page
[153] [154]

[155] Irvine, CA, U.S. Laboratory design, renovation, relocation, and construction
LCS Constructors, Inc. Services page
[156]

Ramsey, NJ, U.S. Laboratory design and renovation

Longo, Inc. dba Longo Lab Design Services page
[157] [157]

[158] San Diego, CA, U.S. Laboratory assessment, benchmarking, and design
Research Facilities Design Services page
[159]

[160] Geneva, Switzerland Wide array of services, including laboratory assessment and
SGS S.A. Services page
design for the petrochemical industry [161]

Arlington, VA, U.S. Laboratory assessment, benchmarking, and design

Strategic Science & Technology Services page
[162] [163]
Planners, Inc.

Pasadena, TX, U.S. Laboratory design, construction, and certification; instrument

Superior Laboratory Services, Inc. Services page
[164] evaluation; training [165]

Lorton, VA, U.S. Forensic laboratory design, construction, and certification;

The Bode Technology Group, Inc. Services page
[166] instrument and software [165]
system evaluation; workflow development; quality assessment;
training
Laboratory informatics consultants 146

References
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Laboratory informatics consultants 147

[58] http:/ / www. orbislabsystems. com/ services

[59] http:/ / www. q2marketsite. com/
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[115] http:/ / www. lab-data. com/
[116] http:/ / www. lab-data. com/ Consulting. aspx
Laboratory informatics consultants 148

[117] http:/ / www. narayanconsultinginc. com/

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[166] http:/ / www. bodetech. com/
21 CFR Part 11: Audit guidelines and checklist 149

21 CFR Part 11: Audit guidelines and checklist

The following guidelines and checklist items provide a frame of reference for vendors and auditors to better
determine potential compliance issues with Title 21 Code of Federal Regulations Part 11 and a variety of other
regulatory guidelines.
All items in the checklist for general IT controls should also be checked for individual systems, especially where
those systems use different control measures (e.g., they have an independent authentication system).
If this checklist is used by software vendors, then certain elements may or may not apply depending on the
circumstances. For instance, validation is technically the responsibility of the entity acquiring the software.
However, in the case of SaaS, a greater practical responsibility to validate the system may lie with the vendor. In all
cases, the vendor should assume responsibility for ensuring that their software operates as intended within the
targeted environments. Failure to do so may result in a lack of willingness of potential customers to obtain the
system.
References will be provided for each checklist item to indicate where the requirement comes from. These references
are either to the regulation itself, Agency responses in the Final Rule, or from the guidance document "General
Principles of Software Validation; Final Guidance for Industry and FDA Staff" (GPSV).

General IT
Following is a list of questions that either apply to the larger IT environment, or to both the larger environment and
to individual systems. The auditor must be sure to evaluate both where necessary. For instance, an organization may
have a robust password policy which is managed by a centralized identity management tool. This is important
evaluate in terms of general security around the systems in scope. At the same time, the specific system may or may
not leverage the corporate IDM and thus its identity management should be evaluated on its own merits.

Computer Systems Validation - 21 CFR 11.10(a)

Does a defined computer system validation policy exist? - 21 CFR 11.10(a)
Are all computer systems involved in activities covered by predicate regulations validated? - 21 CFR 11.10(a), 21
CFR 211.68(b), 21 CFR 820.30(g)
Does the computer system validation cover the current deployed version of the system? - GPSV 4.7
Validation Assessment
Does the software developer have a defined systems development life-cycle (SDLC)? - GPSV 4.4
Does the SDLC reflect a generally recognized life cycle approach? [1]
Is the SDLC followed? - GPSV 4.4
Is the software well documented from a design/development/implementation perspective? - GPSV 3.3
Is there evidence of design review activities (what this entails will depend on the nature of the SDLC - for
instance, Agile methodologies will involve daily standup meetings,while a waterfall approach may reflect
formal design review steps)? - GPSV 3.5
Does the level of validation coverage reflect the risk from system failure? - GPSV 6.1
Is there sufficient level of independence in the validation/verification activities? - GPSV 4.9
Are sufficient resources and personnel provided for software development and validation? - 21 CFR 211.25(c),
21 CFR 820.25(a)
Are records maintained of defects and failures identified in the development process? - GPSV 5.2.6
For any software system, is there a set of approved requirements which drove the design (note: the name can
vary based on the SDLC in use). - GPSV 6.1
21 CFR Part 11: Audit guidelines and checklist 150

For iterative development approaches, are previous versions of deliverables (such as requirements lists)
archived in some fashion? - GPSV 5.2.1
Is there an audit trail for modifications to system documentation? - 21 CFR 11.10(k)(2)
For commercial off-the-shelf (COTS), has the vendor been evaluated for its quality systems? - GPSV 6.3
Is there some form of traceability that permits tracking of test results and verification activities to specific
requirements? - GPSV 5.2.2
Are adequate change control systems in place during the development and implementation processes? GPSV
3.3
For each of the other elements of this checklist that apply directly to an electronic record system, has
appropriate validation work been undertaken to establish that the system complies with the checklist item?

Identity Management Systems

Do any identity management systems have minimum password complexity/strength requirements? Do these
minimums seem reasonable? - 21 CFR Part 11 Final Rule Section 130
Do these id systems have policies regarding password change frequency? - 21 CFR 11.300(b)
Do identity management systems prevent the creation of duplicate user IDs? [2]

Access Controls
Do formal procedures exist governing user account creation for electronic records systems.
Do formal procedures exist governing access to network and server resources that are used to operate electronic
records systems?

Cloud Computing Policies[3]

Are policies in place governing the selection and use of cloud vendors for electronic record systems?
Do these policies include Service Level Agreements(SLA's) regarding such things as up time, and support
responsiveness?
Are cloud vendors evaluated for security and compliance with appropriate regulations?
Do policies governing record retention specifically apply to cloud vendors?
Are systems for transmitting electronic records configured to do so in a secure manner? 21 CFR 11.30

Training and Personnel

Is an organizational chart available covering personnel involved in the design, development, administration or use
of electronic records systems?
Are job descriptions available for these individuals, indicating their specific responsibilities regarding electronic
record systems?
Is there a defined training program around authentication practices? Electronic signatures?21 CFR 11.10(i)
Are system administrators and developers trained in Part 11 and related regulations? 21 CFR 11.10(i)
Are users trained on the use of electronic records systems? 21 CFR 11.10(i)
21 CFR Part 11: Audit guidelines and checklist 151

Change Control Systems

Is there a formal change control system for modifications to the production electronic records system? GPSV
5.2.7
Does the change control system require an assessment of impact, risk, and require authorization before
proceeding? GPSV 6.1
Is there a configuration management system in place such that the contents of each version of released software is
archived and readily identifiable? GPSV 5.2.1
Is there a formal change control system for changes to requirements and design elements of the system during the
development process? GPSV 3.3
Do change control systems in use require appropriate approvals as governed by the SDLC model in use?

Electronic Signature Certification

If the organization is using electronic signatures, have they filed a certification with the FDA indicating so? 21
CFR 11.100(c)

Records Retention Policy

Does the organization have a records retention policy covering records per the predicate regulations? 21 CFR
11.10(c)

System Specific

Fraud Detection
Is the system designed to either prevent record alteration or make such alteration apparent? 21 CFR 11.10(a)

Audit Trails
Does the system maintain an audit trail that tracks changes to electronic records? 21 CFR 11.10(e)
Are the audit trail records time stamped? 21 CFR 11.10(e)
Are the audit trail records system generated, such that human intervention is not required? 21 CFR 11.10(e)
Are audit trail records secured such that they cannot be modified by users of the system? 21 CFR 11.10(e)
Is the audit trail data available for export (printing or electronic) to support agency review? 21 CFR 11.10(e)

Access Controls
Does the identity management systems have minimum password complexity/strength requirements? Do these
minimums seem reasonable? 21 CFR Part 11 Final Rule Section 130
Do these id systems have policies regarding password change frequency? 21 CFR 11.300(b)
Do identity management systems prevent the creation of duplicate user IDs?

Open Systems Controls[4]

Are records transmitted by the system sent in a secure manner, such that their authenticity, integrity and
confidentiality are ensured? 21 CFR 11.30
Is access to the system appropriately managed to prevent unauthorized external access?
Has the system been evaluated for susceptibility to intrusion?
Is there a system in place to evaluate current IT security threats that have been identified (by the National Cyber
Awareness System via NIST, or other appropriate organization)?
21 CFR Part 11: Audit guidelines and checklist 152

Electronic Signatures
Is the electronic signature system engineered in such a way as to ensure that the signatures cannot be attached to
other records, or cannot be removed from the records they are attached to? - 21 CFR 11.70
Is the system engineered such that in order to apply someone elses signature to a file that collaboration is
required between two or more individuals? (this is largely covered by the identity management controls). - 21
CFR 11.200(a)(3)
If a signature event only requires one signature element, is it only in the case of being part of a continuous period
of system access? - 21 CFR 11.200(a)(1)(i)
Are their suitable loss management procedures in place to address compromised passwords, or lost/stolen
authentication devices (such as RSA ID tokens)? - 21 CFR 11.300(c)
Is the system designed to alert security and/or management in the event of an apparent attempt at unauthorized
use of electronic signatures? Does the system automatically take steps to lock out users associated with these
attempts? - 21 CFR 11.300(d)
Is there a system for the periodic testing of tokens and cards to ensure that they are still operating as expected and
have not been altered? If not, is there something in the nature of the tokens/cards that would render them unusable
should alteration be attempted? - 21 CFR 11.300(e)
Is there a password reset method that does not require system administrators to know a users password? - 21 CFR
Part 11 Final Rule Section 123
Are user passwords suitably encrypted in any persistent data store, such that elucidating the original password
would require extraordinary means?
Are controls in place to ensure that password reset instructions are sent to the correct individual?

Export of Records for Agency Review

Does the system support exporting records in a format that is readable by the agency? - 21 CFR 11.10(b)
If the agency hasnt been specifically consulted with regard to acceptable formats, does the system support export
into common formats such as XML or JSON?

Records Retention Support

Does the system have sufficient controls to ensure that the records stored within it will be available throughout the
period specified in the records retention policy? - 21 CFR 11.10(c)

Process Controls
Does the system have a mechanism to establish differing levels of authority to perform tasks in the system? - 21
CFR 11.10(g)
Does the system have a mechanism for preventing steps being taken out of sequence (e.g., signing a record before
data has been entered, or releasing a record before the review step was completed)? - 21 CFR 11.10(f)

Reference material

21 CFR Part 11
Subpart A General Provisions
11.1 Scope [1]
11.2 Implementation [2]
11.3 Definitions [3]
Subpart B Electronic Records
21 CFR Part 11: Audit guidelines and checklist 153

11.10 Controls for closed systems [4]

11.30 Controls for open systems [5]
11.50 Signature manifestations [6]
11.70 Signature/record linking [7]
Subpart C Electronic Signatures
11.100 General requirements [8]
11.200 Electronic signature components and controls [9]
11.300 Controls for identification codes/passwords [10]

General Principles of Software Validation

The full name of this FDA guidance document is "General Principles of Software Validation; Final Guidance for
Industry and FDA Staff," referenced on here as "GPSV."
Section 1. Purpose [5]
Section 2. Scope [6]
2.1. Applicability
2.2. Audience
2.3. The Least Burdensome Approach
2.4. Regulatory Requirements for Software Validation
2.4. Quality System Regulation vs Pre-Market Submissions
Section 3. Context for Software Validation [7]
3.1. Definitions and Terminology
3.1.1 Requirements and Specifications
3.1.2 Verification and Validation
3.1.3 IQ/OQ/PQ
3.2. Software Development as Part of System Design
3.3. Software is Different from Hardware
3.4. Benefits of Software Validation
3.5 Design Review
Section 4. Principles of Software Validation [8]
4.1. Requirements
4.2. Defect Prevention
4.3. Time and Effort
4.4. Software Life Cycle
4.5. Plans
4.6. Procedures
4.7. Software Validation After a Change
4.8. Validation Coverage
4.9. Independence of Review
4.10. Flexibility and Responsibility
Section 5. Activities and Tasks [9]
21 CFR Part 11: Audit guidelines and checklist 154

5.1. Software Life Cycle Activities

5.2. Typical Tasks Supporting Validation
5.2.1. Quality Planning
5.2.2. Requirements
5.2.3. Design
5.2.4. Construction or Coding
5.2.5. Testing by the Software Developer
5.2.6. User Site Testing
5.2.7. Maintenance and Software Changes
Section 6. Validation of Automated Process Equipment and Quality System Software [10]
6.1. How Much Validation Evidence Is Needed?
6.2. Defined User Requirements
6.3. Validation of Off-the-Shelf Software and Automated Equipment

Others
21 CFR Part 211 [11]: Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR Part 820 [12]: Quality System Regulation

References and footnotes

[1] While the Agency specifically does not recommend an SDLC, and rightfully so, established SDLC approaches become established typically
due to the quality of product that comes from them. An SDLC that is either unique or a blend of disparate approaches may merit additional
attention on the part of the auditor
[2] Although the regulation only specifies that identification codes in combination with passwords must be unique, since passwords are typically
stored in encrypted format, there is no practical way to do this outside of ensuring that user ID's are unique
[3] In general there was little anticipation when Part 11 was drafted that such a thing as the cloud would come to exist. These checklist items,
therefore, are reasonable extensions of requirements for in house systems.
[4] The field of IT security has exploded in recent years with a number of high profile breaches. At the time of the writing of Part 11, the internet
was much safer in this regard than it is today. The auditor should focus significant effort on security around all systems, but especially open
systems.
[5] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237928
[6] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237929
[7] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237935
[8] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237944
[9] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237955
[10] http:/ / www. fda. gov/ medicaldevices/ deviceregulationandguidance/ guidancedocuments/ ucm085281. htm#_Toc517237965
[11] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ cfrsearch. cfm?cfrpart=211
[12] http:/ / www. accessdata. fda. gov/ scripts/ cdrh/ cfdocs/ cfcfr/ cfrsearch. cfm?cfrpart=820
Health Insurance Portability and Accountability Act: Audit guidelines and checklist 155

Health Insurance Portability and Accountability

Act: Audit guidelines and checklist
The following guidelines and checklist items provide a frame of reference for vendors and auditors to better
determine potential compliance issues with the Health Insurance Portability and Accountability Act and a variety of
other regulatory guidelines.
The following checklist is focused largely on computerized systems that house Protected Health Information (PHI)
under the HIPAA regulations. However, since the computerized system exists as part of a complete operation, even
when it is hosted by a Cloud provider, the checklist covers the majority of the regulation. This notion of the
requirements of the entire regulation applying even to Cloud companies is particularly underscored with the
HITECH modifications to the HIPAA regulations where Business Associates are now entirely responsible with
adherence to the HIPAA privacy regulations and not merely on a contractual basis.

Administrative safeguards
Security Management Process
Does a detailed risk assessment exist regarding potential vulnerabilities to the confidentiality, integrity, and
availability of PHI?
Does the assessment identify actions to mitigate certain risks? Have these actions been taken, or have plans been
generated to take these actions?
Does a policy exist specifying sanctions to be taken against employees who fail to comply with security policies
and procedures?
Is there a system in place for regular review of system activity, including things such as audit logs and incident
reports?

Assigned security responsibility

Is there a formally identified individual who is responsible for developing and implementing security policies?
Has this individual, or the individual's direct reports, developed and implemented security policies?
Collect evidence of security policies being implemented (group policy reports for the AD server, for instance)

Workforce security and Information Access Management

Do procedures exist governing access to PHI by employees?
Are employees who should not have access to PHI prevented from accessing it?
If employees are permitted to access systems that contain PHI, but are not permitted to access PHI, does the
system have suitable controls to prevent that access?
View system accesses by both individuals who have access to PHI and those who don't, and evaluate potential
areas of weakness in the security measures.
Do processes exist for authorizing access to PHI? Do these processes seem reasonable.
Are employees who have access to PHI supervised appropriately? Do their supervisors have adequate training and
understanding regarding the treatment of PHI?
Are adequate procedures in place governing the termination of employees with access to PHI?
Do these procedures include appropriately times termination of accounts (i.e., in the case of involuntary
termination, is the account terminated before the employee might have the opportunity to cause harm?).
For voluntary terminations, are procedures in place that require the supervisor to evaluate the need for continued
access to PHI prior to the departure of the employee in question?
Health Insurance Portability and Accountability Act: Audit guidelines and checklist 156

Is there a clear requirement for communication with system administrators and IT staff regarding affected
accounts?
If a health clearinghouse is part of a larger organization, confirm that adequate controls exist that prevent the
larger organization from accessing PHI.
Do the PHI access procedures apply to the IT/IS organization? That is, is access to PHI only allowed for IT/IS
employees with a legitimate business reason to access that data? Are IT/IS employees adequately trained in the
HIPAA regulations, internal policies and procedures regarding PHI?

Security Awareness and Training

Is there a formal and documented training program for employees who deal with PHI?
Are employees provided training on principles of security?
Are there procedures in place for addressing malicious software, including it's detection and reporting? Are
employees prevented from accessing remote sites that are at high risk for containing malicious software?
Is there a system for ensuring that security protection software (in particular anti-virus programs, and firewalls)
are updated periodically?
For outward facing applications, is there a process by which security flaws in components (such as Java) are
identified and fixed.
For systems that provide access to PHI, do they track log-ins, and in particular failed logins?
Does the system lock out users after a specified number of failed logins?
Are system administrators notified if such an event occurs?
Is there evidence that administrators respond to such events in an appropriate manner?
Are there policies governing password complexity, change and reuse frequency? Are the policies consistent with
current "standards" within the industry?
Are employees trained to maintain strict secrecy regarding their passwords?
Are there procedures mandating that IT may not request passwords from users?

Security Incident Procedures

Are procedures in place for responding to security incidents?
Is there evidence that these procedures are being followed (review any logs/files regarding actions taken in
response to security incidents).

Contingency Plan
Does the organization have a comprehensive disaster preparedness/business continuity plan?
Does the plan included a backup and recovery procedure for all system data?
Does the plan adequately address how operations can be continued under various scenarios?
Does the plan include procedures for testing the various elements of the plan to ensure they are still valid?
Does the plan address the criticality of the various systems in its design?
Health Insurance Portability and Accountability Act: Audit guidelines and checklist 157

Evaluation
Is a periodic re-evaluation of security standards undertaken?
Does the re-evaluation take into account changes in the current state of IT security and the environment of threats
facing secured systems, as well as the current state of the regulations?

Business Associate Agreements

If components of the system are held outside the direct control of the company, such that PHI will be outside of
the direct control of the company, do sufficient agreements exist to guarantee that the party responsible for
handling the PHI will adhere to the requirements of the regulation?
Are these agreements in such a form that they qualify as a contract or equivalent?

Physical safeguards
Facility Access Controls
Is the facility containing the system (this includes electronic access points that connect to the system in a
"non-secure" manner) sufficiently protected from unauthorized access?
Is access to application and database servers further restricted to only those personnel who are authorized to
directly interact with those elements of the system (i.e., system administrators).
Is there a system that limits access to facilities and areas within facilities to authorized personnel? Does this
system implement a mechanism for confirming the identify of individuals accessing the facility (e.g., through a
electronic key access system)
Does this system apply to visitors as well?
Is access to systems used for testing and revision of software similarly restricted? Evaluate the access restrictions
to tools that could be used to modify and deploy the software. Ensure that these access restrictions are addressed
via SOP.

Workstation Use
Do procedures exist which govern the class of workstation that can be used to access PHI?

Workstation Security
Are workstations that are used to access PHI appropriately restricted?
If workstations can directly interact with PHI without additional controls, are the workstations secured in
appropriately restricted areas?

Device and Media Controls

Are procedures in place governing the use and removal of hardware and storage media used to house PHI?
Do the procedures seem reasonable?
Do procedures exist regarding the disposal of media and devices used to store PHI?
Are records maintained that account for the movement of such media, and who moved it?
Health Insurance Portability and Accountability Act: Audit guidelines and checklist 158

Technical safeguards
Access Control
Do systems with access to PHI have a robust authentication process for gaining access?
Do these system require that all users have a unique id?
Are password assignment, change, recovery, and related processes designed in such a way so as to ensure that the
user gaining access to PHI is who they say they are?
Is there a mechanism for gaining access to necessary PHI in the event of an emergency? Is this mechanism
designed such that it's invocation during non-emergencies would not be achievable in a non-obvious way?
Does this system automatically log off users after a defined period of inactivity?
Does the system maintain PHI in an encrypted state?

Audit Controls
Do systems used for PHI maintain audit trails which record, in a secure manner, all activities within the system.
Are the audit trails reviewed periodically?

Integrity
Are policies and procedures in place to ensure that PHI has not been altered or destroyed in an unauthorized
manner?
Are electronic mechanisms employed to corroborate that PHI has not been altered or destroyed in an unauthorized
manner?*
If PHI is transmitted outside of the responsible entity (i.e., via the internet), is the data transmitted in such a way
so as to prevent unauthorized access (via ssl or similar protocols?)
Are security certificates on servers involved in managing PHI current, and authenticated by a recognized third
party certifying organization?

Organizational requirements
Business associate contracts
Are business associates required contractually to adhere to the regulations with regard to PHI they maintain?
Do business associate agreements exist with third party data/application hosting services?
Do business associate agreements extend, contractually, to agents/subcontractors?
Is it clear within the terms of the business associate agreements that the business associate must immediately
report any breaches or incidents?
Is it clear within the terms of the business associate agreements that the relationship can be terminated if the
associate fails to comply with the requirements of the regulations?
Do records exist of audits and other reviews of business associates? If breeches or violations of the regulation
have occurred, have appropriate actions been taken, up to and including termination of the agreement?
Health Insurance Portability and Accountability Act: Audit guidelines and checklist 159

Documentation requirements
Documentation
Are the procedures required by the regulations maintained in written (or alternatively electronic, but signed)
form?
Are actions and activities which are required to be documented maintained in written form (or electronic
alternatives)?
Is there a retention policy regarding the policies and procedures? Does the policy require that such documents be
maintained for at least 6 years after either the date of its creation or of its effective date (whichever is later)?
Does a review system exist for these policies and procedures to ensure that they are current?

Laboratory information management system

(LIMS) questionnaire
The intention of this document is 1. to assist labs searching for a laboratory informatics product with identifying their
system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of
a request for information (RFI). The idea is to allow users to incorporate a standardized specifications sheet in their
comparison of various LIMS and other laboratory informatics products.
This questionnaire lists the extensive requirements of a LIMS as well as other laboratory informatics systems. (See
below for more about this.) The questionnaire is organized such that sections 1.0 through 1.4 offer questions
applicable to most any laboratory informatics system, be it a LIMS or an ELN. Section 1.5 covers functionality
found specifically in software systems other than LIMS.
This questionnaire is comprehensive and includes many items that do not apply to every lab. Additionally, some
laboratories' requirements include a functionality item not common to other labs. Section 1.6 "Industry-specific"
contains a selection of those industry-specific requirements and will continue to be amended over time. The last
section, 1.7 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall
under the categories provided.
When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g.
1.4.2.f for "Does your system allow the administrator to create custom screens, applications, and reports? Please give
details."

More about this questionnaire

As noted above, this questionnaire was originally designed to cover aspects of a laboratory information management
system (LIMS). However, a significant portion of this page if not most of it could easily apply to other laboratory
informatics systems like ELNs. As such, we took the approach of adding addenda (as seen in section 1.5 and 1.6)
that provide additional requirements unique to other systems and industries. If you're evaluating several
industry-neutral LIMS, you likely don't need 1.5 and 1.6.
Laboratory information management system (LIMS) questionnaire 160

Requirement code and notes

In responding to each requirement, the vendor must select a requirement code from the following:
Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
N: Does not meet requirement
I: Informational response only, N/A
The vendor should ideally enter a requirement code and a response for each functionality question.

Printing or saving
The print/export options in the navigation on the far left give you a few options for saving this and other pages,
printing them for later.
Notice you'll have to open 1.5 and 1.6 in separate pages to view, print, and save them.
Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension [1].
While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended,
using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable
version" and printing that instead.

1.0 Vendor information

1.0 Vendor information

Company name

Physical address

Website

LIMSwiki web page

Contact name and title

Contact e-mail

Contact phone and fax

Years in business

1.1 Vendor services

1.1 Vendor services

Request for information Requirement Vendor

code response

a. The vendor offers an online and/or on-site demonstration.

b. The vendor provides a detailed project plan that includes the project team, timeline, deliverables, and risk and
issue management procedures.

c. The vendor explains their overall project approach, deliverables, time constraints, and any other criteria for the
project.

d. The vendor provides reliable cost estimates and pricing schedules, including all products and services in the
scope of work.

e. The vendor details the amount of time and staff that the purchaser will have to provide for the implementation
process.
Laboratory information management system (LIMS) questionnaire 161

f. The vendor can explain the maintenance and support offered during and after implementation, including times
and methods of availability, issue escalation and management, etc.

g. The vendor provides a support schedule for the implementation process, including optional support levels,
their function, and availability.

h. The vendor provides support during the "go-live" period between system validation/operational deployment
and final acceptance/beginning of maintenance and support agreements.

i. The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks
remaining.

j. The vendor provides a table linking each deliverable to the corresponding user requirement specification it
fulfills.

k. The vendor uses a consistent training methodology for educating new users.

l. The vendor supplies LIS-specific training program curricula.

m. The vendor provides user, administrator, developer, installation, and reference manuals.

n. The vendor provides design qualification documentation.

o. The vendor provides installation qualification documentation.

p. The vendor provides operation qualification documentation.

q. The vendor provides performance qualification documentation during implementation.

r. The vendor provides well-documented system upgrades that authorized users can independently install.

s. The vendor provides source code for the system.

t. The vendor provides an optional comprehensive set of test codes suitable for use by the purchaser.

1.2 Information technology

1.2.1 General IT

1.2.1 General IT

Request for information Requirement Vendor

code response

a. The system operates with a traditional client-server architecture, with software installed on each machine that
needs to access the system.

b. The system operates with a web-based interface, hosted on a server and accessed via a web browser on most
any machine.

c. The system contains a single, centralized database that supports multiple sites and departments.

d. The system's database conforms to the Open Database Connectivity Standard (ODBC).

e. The system is designed so upgrades to the back-end database do not require extensive reconfiguration or
effectively cripple the system.

f. The system is designed to not be impacted by multiple users or failover processes.

g. The system applies security features to all system files.

h. The system applies log-in security to all servers and workstations accessing it.

i. The system provides a workstation and server authentication mechanism.

j. The system applies Secured Socket Layer (SSL) encryption on the web client interface.

k. The system encrypts client passwords in a database, with support for multi-case and special characters.

l. The system uses TCP/IP as its network transport.

Laboratory information management system (LIMS) questionnaire 162

m. The system provides data archiving functionality, including a configurable scheduled archive, for all contained
data, without requiring an off-line mode or human interaction with the data to be archived.

n. The system allows automated backup and restore capability without support intervention, as well as manual
backups.

o. The system maintains the transactional history of system administrators.

p. The system maintains an analyst communication log, accessible by the administrator.

1.2.2 Hardware environment

1.2.2 Hardware environment

Request for information Requirement code Vendor response

a. The system proves compatible with a variety of hardware environments.

b. The system can be utilized with a touch-screen.

1.2.3 Software environment

1.2.3 Software environment

Request for information Requirement code Vendor response

a. The system proves compatible with a variety of software environments.

b. The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.

1.3 Regulatory compliance and security

1.3.1 Regulatory compliance

1.3.1 Regulatory compliance

Request for information Requirement Vendor

code response

a. The system supports 21 CFR Part 11 and 40 CFR Part 3 requirements, including login security, settable
automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and
full electronic signature.

b. The system supports ISO/IEC 17025 requirements.

c. The system supports HIPAA requirements.

d. The system supports GALP and/or GAMP standards.

e. The system supports the standards of The NELAC Institute.

f. The system meets government requirements for handling classified information and documents.

g. The system maintains audit and specification violation trails of all data manipulation such as result and
header information changes as consistent with all applicable regulations and standards.

h. The system maintains audit trails at least as long as the records to which they pertain.

i. The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of
contained information.

j. The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled
system functions.
Laboratory information management system (LIMS) questionnaire 163

k. The system provides user-selectable NELAP-compliant internal chain of custody that tracks all specimens and
associated containers from the time they are collected until disposed of.

l. The system provides the ability to insert/manage secure electronic and/or digital signatures.

m. The system incorporates automatic date and time stamping of additions, changes, etc.

n. The system can automatically validate and approve data prior to being moved to the main database.

1.3.2 Security

1.3.2 Security

Request for information Requirement Vendor

code response

a. The system allows administrators and other authorized users to configure multiple levels of user rights and
security by site location, department, group, role, and/or specific function.

b. The system allows administrators and users to reset user passwords.

c. The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.

d. The system can lock a user out after a specified number of consecutive failed log-in attempts.

d. Does your system provide automatic logout based on keyboard or mouse inactivity?

e. The system provides the option for automatic user logout based on keyboard or mouse inactivity.

f. The system makes authority checks to ensure only authorized individuals can use the system to perform an
operation.

g. The system allows authorized users to modify records, while also maintaining an audit trail of such actions.

h. The system allows authorized users to manually delete records, while also maintaining an audit trail of such
actions.

i. The system prompts users to declare a reason for making changes to or deleting data in the system.

j. The system provides email notification of lockout, security access, and improper workstation access.

k. The system provides a mechanism to allow a user read-only access to stored data.

l. The system allows authorized users to generate a detailed user access record.

m. The system allows authorized users to review audit logs at will.

n. The system allows authorized users to query and print chain of custody for items, cases, projects, and batches.

o. The system allows supervisors to override chain of custody.

p. The system automatically tracks when supervisors review critical result values.

q. The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or
remains retrievable during a retention period.

r. The system can first feed data from connected non-CFR-compliant instruments through a virtual environment
that is compliant (audit trailed, secure, versioned, etc.) before being stored.

s. The system can control whether users are able to export data to portable long-term storage media like a USB
flash drive or recordable DVD.

t. The system employs automatic file encryption on stored data.

u. The system employs checks to enforce permitted sequencing of steps and events.

v. The system allows multiple users to connect simultaneously to a contract lab.

w. The system provides read-only access to contract laboratory results.

x. The system prohibits issuing reports outside of qualified areas while also allowing reports to be viewed locally
or remotely based on security application limits and/or specimen ownership.
Laboratory information management system (LIMS) questionnaire 164

1.4 General system functions

1.4.1 General functions

1.4.1 General functions

Request for information Requirement Vendor

code response

a. The system offers non-LIMS trained personnel the ability to easily access system data via an intuitive,
user-friendly Windows-type graphical user interface (GUI) which permits the display of data from specimen points,
projects, and user-defined queries, and can be configured to language, character set, and time zone needs.

b. The system allows authorized users to configure their GUI to a specific language, character set, and time zone.

c. The system permits remote access for users, system admins, and support agents.

d. The system allows for the use of navigation keys to freely move from field to field.

e. The system allows tabular data to be sorted and filtered.

f. The system can send on-screen output to a printer or file without contradicting view-only statuses.

g. The system provides single data entry, automatically populates other data fields, and remembers pertinent and
relevant data so it doesn't need to be re-entered, selected, or searched for.

h. The system eliminates (or significantly reduces) redundant data entry and paper trails.

i. The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove
entries.

j. The system provides full database keyword and field search capability, including the use of multiple search
criteria.

k. The system includes the ability to search multiple databases, including those containing legacy data.

l. The system allows users to build, save, and edit queries for future use.

m. The system can automate the search for and extraction of pertinent data, including the export of that data to
external applications for additional processing and calculation.

n. The system cleanly converts migrated data to allow for reporting of historical specimen collections.

o. The system allows for the specification of a retention period for captured data and can enact it based on
date-based fields or a future event.

p. The system can manage and store both sample- and non-sample-related data, including images from microscopes,
GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing.

q. The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.

r. The system issues sequential numbers for chain of custody.

s. The system's numbering scheme allows for sub-numbering while maintaining parent-child relationships.

t. The system efficiently utilizes standardized data input points and enhanced individual workload tracking.

u. The system captures data from all laboratory processes, ensuring uniformity of statistical reporting and other
electronic data shared with designated users of the data.

v. The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.

w. The system notifies users of events like the scheduling, receipt, and completion of tasks.

x. The system includes the ability to set up alerts via email.

y. The system has real-time messaging capabilities, including instant messaging to one or more users.

z. The system supports the use of a voice recognition system (for navigation or transcription) or has that
functionality.
Laboratory information management system (LIMS) questionnaire 165

aa. The system offers integrated or online user help screens.

1.4.2 Configuration and customization

1.4.2 Configuration and customization

Request for information Requirement Vendor

code response

a. The system can be configured to meet the workflow of a laboratory without additional programming.

b. The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the
addition of new functionality as business needs change.

c. The system has an application programming interface (API) or a similar software development toolkit (SDK). If
web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST),
or both.

d. The system can expand to accommodate a new discipline.

e. The system supports customized screens with user-definable information specific to a customer, department,
analysis, etc.

f. The system allows the administrator to create custom screens, applications, and reports.

g. The system allows a user to independently add fields without requiring reconfiguration of the system, even after
routine upgrades and maintenance.

h. The system allows a user to independently add universal fields on all samples logged into the system at any time
during or after implementation, while neither voiding the warranty nor requiring vendor review at a later date.

i. The system supports the definition and maintenance of edit tables and lists.

j. The system dynamically changes captions (labels) on system fields.

k. The system has dynamically configurable limit periods and notification hierarchy.

l. The system allows for the integration of additional printers and scanners both locally and externally.

1.4.3 Receiving and scheduling

1.4.3 Receiving and scheduling

Request for information Requirement Vendor

code response

a. The system tracks status and workflow of the accession throughout the laboratory lifecycle, from submission to
final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing.

b. The system supports barcoded specimen labeling and tracking.

c. The system allows users to create, manage, and track viewable sample container schemata.

d. The system creates and maintains a unique electronic accession record for each accession received.

e. The system supports standard-format digital picture and document upload and attachment to electronic accession
records.

f. The system supports a user-configurable, spreadsheet-style, templated multi-specimen (batch) login without
requiring additional programming.

g. The system supports the modification of specimen or specimen batch information prior to actual multi-sample
(batch) login.

h. The system supports ad-hoc specimens not predefined in the specimen point list during multi-sample (batch)
login.
Laboratory information management system (LIMS) questionnaire 166

i. The system creates, saves, and recalls pre-login groups for routine samples to simplify recurring logins.

j. The system streamlines the login of recurring sample projects.

k. The system automatically generates labels for recurring samples and sample groups.

l. The system allows authorized users to generate user-definable or rules-based chain of custodies, worksheets,
routing sheets, and custom labels upon sample login.

m. The system provides a comprehensive view of all samples and projects in the system using a color-coded status
view of the current and scheduled samples via user-configurable templates, all without requiring additional
programming.

n. The system includes environmental monitoring (EM) functionality or integrates with an external EM product.

o. The system prevents a sample from being placed in a report queue until approved.

p. The system includes comprehensive scheduling, tracking, and flow management of samples, including across
multiple sites.

q. The system is capable of geographically organizing sample records and their associated tests for special analysis
and reporting.

r. The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for a
given sample.

s. The system allows authorized users to review the available test types in the system, including their reference
range and units of measure.

t. The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed.

u. The system allows authorized users to schedule routine samples on an hourly, daily, weekly, or monthly basis,
allowing them to be enabled and disabled as a group.

v. The system generates an hourly, daily, weekly, or monthly sample collection schedule from a scheduling
database.

w. The system schedules and assign tasks based on available inventory and personnel.

x. The system supports automatic assignment and scheduling of analysis requests.

y. The system receives accession/analysis request information from web-enabled forms.

z. The system electronically receives and processes collection and analysis request information and schedules from
third parties.

aa. The system has an inter-lab transfer function.

ab. The system processes automated uploading of field-derived sample collection data.

ac. The system allows users to handle billable and non-billable tests on the same accession.

ad. The system supports tracking of shipping and receiving.

1.4.4 Analysis and data entry

Laboratory information management system (LIMS) questionnaire 167

1.4.4 Analysis and data entry

Request for information Requirement Vendor

code response

a. The system supports a variety of test protocols, each capable of storing test comments, test required, and special
information like GCMS conditions or special objects associated with the test.

b. The system provides and enforces normal data range values for diagnostic tests.

c. The system includes default input values for diagnostic tests.

d. The system provides for a single test code requiring multiple analytes as targets.

e. The system allows authorized users to make a test code inactive across one or more sites while retaining it for
audit and reporting purposes.

f. The system limits test code authorization to only qualified personnel and maintains their certification(s) to run
assigned tests.

g. The system supports and qualifies text-based tests.

h. The system supports single-component tests such as pH, BOD, CD, etc.

i. The system allows users to specify a single-component, multi-component, or narrative text test or group of tests,
which represent all tests required.

j. The system can effectively manage complex molecular testing protocols.

k. The system can effectively manage genetic testing protocols.

l. The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to
all tests.

m. The system distinguishes between routine and duplicate analysis.

n. The system provides an overview of all outstanding tests/analyses for better coordination of work schedules.

o. The system notifies analysts of applicable safety hazards associated with a sample, reagent, or test before testing
begins.

p. The system electronically transfers an item during testing from one functional area to another.

q. The system's user interface displays visual indicators such as status icons to indicate a sample's status in the
workflow.

r. The system allows file transfer of data from instruments via intelligent interfaces or multi-specimen/multi-test
ASCII files, with full on-screen review prior to database commitment.

s. The system permits manual data entry into an electronic worksheet of test measurements and results.

t. The system allows incorrectly inputted data to be manually corrected.

u. The system prevents out-of-range and other critical results from being posted as final.

v. The system provides colored visual indication of previously entered data as well as new data associated with a
single sample when a result is entered, with the indicator changing color if the value is out of specification.

w. The system allows automated or semi-automated data insertion.

x. The system stores non-narrative textual results in searchable fields.

Laboratory information management system (LIMS) questionnaire 168

1.4.5 Post-analysis and validation

1.4.5 Post-analysis and validation

Request for information Requirement Vendor

code response

a. The system updates sample/item status when tests are completed.

b. The system automatically reorders a test or orders additional tests if results don't meet lab-defined criteria,
especially when the original sample is still available.

c. The system reads results from previously entered tests to calculate a final result and immediately displays the
calculated result.

d. The system allows authorized users to review all analytical results, including pricing, spec violations, history or
trend analysis by analyte, and comments.

e. The system graphically displays the results of one or more tests in a graph (normalized or otherwise) for the
purpose of visualizing data or searching for possible trends.

f. The system allows on-screen review of the stored test result, diluted result with corrected method detection limits
(MDLs), and qualifiers after running samples for multiple dilutions as in gas chromatographymass spectrometry
(GC-MS).

g. The system includes data mining tools for model learning, evaluation, and usage.

h. The system displays the standard operating procedure (SOP) associated with each test result to ensure proper
techniques were used.

i. The system stores test-related analysis comments with the test.

j. The system provides auto-commenting for common laboratory result comments.

k. The system is capable of displaying entered order and test comments as an onscreen alert for testing and other
personnel.

l. The system provides for high-volume multi-component transfers of test results, with the ability to automatically
match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and
commit the sample data.

m. The system's results validation process accesses all information about a sample or group of samples, including
comments or special information about the sample.

n. The system's results validation process checks each result against its individual sample location specifications
(both warning and specification limits).

o. The system supports validation at the analysis and sample level, while also prohibiting sample validation when
analysis validation is incomplete.

p. The system uses a menu-driven process for results validation.

q. The system provides secure electronic peer review of results.

r. The system clearly differentiates released preliminary data from fully validated results.

s. The system validates/approves data prior to being moved to the main database.

t. The system can hold all test results on a sample with multiple tests ordered on it until all work is completed and a
final report is issued.

u. The system fully manages all aspects of laboratory quality control, including the reporting and charting of all
quality control data captured in the lab.

v. The system provides a base for a quality assurance program, including proficiency testing, scheduled
maintenance of equipment, etc.

w. The system distinguishes QA/QC duplicates from normal samples.

x. The system allows QA/QC tests to be easily created and associated with the primary analytical test.
Laboratory information management system (LIMS) questionnaire 169

y. The system allows manual entry of QA and QC data not captured as part of the system's regular processes.

z. The system calculates monthly QA/QC percentages for testing.

aa. The system automatically flags out-of-range quality control limits.

ab. The system is able to flag results for aspects other than being out-of-range, including testing location, test
subject age, etc.

ac. The system checks data files for specification and corrects them for specific reporting and analyte limits and
qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting.

1.4.6 Instruments

1.4.6 Instruments

Request for information Requirement Vendor

code response

a. The system bilaterally interfaces with instruments and related software.

b. The system downloads data directly from laboratory instruments.

c. The system permits the defining and exporting of sequences to instruments.

d. The system tracks and reports on the usage of attached laboratory instruments.

e. The system allows automatic or manual reservation/scheduling of laboratory instruments.

f. The system automatically (or manually allow an authorized user to) removes an instrument from potential use
when it falls out of tolerance limit or requires scheduled calibration.

g. The system provides a database of preventative maintenance, calibration, and repair records for laboratory
equipment, preferably supported by standardized reporting.

h. The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process
and make that schedule available for viewing.

i. The system allows users to create and edit instrument maintenance profiles.

1.4.7 External system interfaces

1.4.7 External system interfaces

Request for information Requirement Vendor

code response

a. The system supports a library of common electronic data deliverable (EDD) formats.

b. The system transfers data to and from another record management system.

c. The system integrates with Microsoft Exchange services.

d. The system imports data from and exports data to Microsoft Word, Excel, and/or Access.

e. The system can interface with non-Microsoft programs.

f. The system interfaces with external billing systems.

g. The system interfaces with enterprise resource planning (ERP) systems.

h. The system interfaces with external contract or reference laboratories to electronically send or retrieve
datasheets, analysis reports, and other related information.

i. The system exchanges data with National Identification System (NAIS) tracking systems.

j. The system generates and exchanges data with other systems using Health Level 7 (HL7) standards.
Laboratory information management system (LIMS) questionnaire 170

k. The system leverages the application programming interface (API) of other systems to establish integration
between systems.

l. The system provides a real-time interface for viewing live and stored data transactions and errors generated
by interfaced instruments and systems.

m. The system transmits status changes of specimens, inventory, equipment, etc. to an external system.

n. The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software.

o. The system supports the manual retransmission of data to interfaced systems.

p. The system supports dockable mobile devices and handle information exchange between them and the
system.

q. The system supports the use of optical character recognition (OCR) software.

1.4.8 Reporting

1.4.8 Reporting

Request for information Requirement Vendor

code response

a. The system includes a versatile report writer and forms generator that can generate reports from any data in tables.

b. The system includes a custom graphic generator for forms.

c. The system interfaces with a third-party reporting application.

d. The system allows the development of custom templates for different types of reports.

e. The system maintains template versions and renditions, allowing management and tracking of the template over
time.

f. The system generates template letters for semi-annual reports.

g. The system supports report queries by fields/keys, status, completion, or other variables.

h. The system use Microsoft Office tools for formatting reports.

i. The system supports multiple web browsers for viewing online reports.

j. The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand,
including narrative.

k. The system includes several standard reports and query routines to access all specimens with the pending status
through a backlog report that includes the following criteria: all laboratory, department, analysis, submission date,
collection date, prep test complete, location, project, specimen delivery group, and other user-selectable options.

l. The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history.

m. The system supports both structured and synoptic reporting.

n. The system generates management and turn-around time reports and graphs.

o. The system generates customized final reports.

p. The system automatically generates laboratory reports of findings and other written documents.

q. The system automatically generates individual and aggregate workload and productivity reports on all operational
and administrative activities.

r. The system automatically generates and transmits exception trails and exception reports for all entered and/or
stored out-of-specification data.

s. The system generates a read-only progress report that allows for printed reports of specimen status and data
collected to date.

t. The system provides an ad-hoc web reporting interface to report on user-selected criteria.
Laboratory information management system (LIMS) questionnaire 171

u. The system automatically generates and updates control charts.

v. The system generates QA/QC charts for all recovery, precision, and lab control specimens via a full statistics
package, including Levy-Jennings plots and Westgard multi-rule.

w. The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend
chart, and statistical summary.

x. The system automatically generates and posts periodic static summary reports on an internal web server.

y. The system transmits results in a variety of ways including fax, e-mail, print, and website in formats like RTF,
PDF, HTML, XML, DOC, XLS, and TXT.

z. The system electronically transmits results via final report only when all case reviews have been completed by the
case coordinator.

aa. The system includes a rules engine to determine the recipients of reports and other documents based on definable
parameters.

ab. The system allows database access using user-friendly report writing and inquiry tools.

1.4.9 Laboratory management

1.4.9 Laboratory management

Request for information Requirement Vendor

code response

a. The system allows the creation, modification, and duplication of user profiles.

b. The system allows entry, maintenance, and administration of customers, suppliers, and other outside entities.

c. The system allows customers, suppliers, and other such entities to be flagged as either active or inactive.

d. The system allows the creation, modification, and maintenance of user training records and associated training
materials.

e. The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple
facilities.

f. The system allows the management of information workflow, including notifications for requests and exigencies.

g. The system allows the management of documents like SOPs, MSDS, etc. to better ensure they are current and
traceable.

h. The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument.

i. The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test, sample,
and priority.

j. The system allows authorized persons to review unassigned work by discipline and by lab.

k. The system allows authorized persons to review pending work by analyst prior to assigning additional work.

l. The system manages and reports on reference samples, reagents, and other inventory, including by department.

m. The system automatically warns specified users when inventory counts reach a definable threshold and either
prompt for or process a reorder.

n. The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration.

o. The system allows authorized users to search invoice information by invoice number, account number, accession,
payment types, client, or requested diagnostic test(s).

p. The system includes performance assessment tracking.

q. The system receives, records, and maintains customer and employee feedback and applies tools to track the
investigation, resolution, and success of any necessary corrective action.
Laboratory information management system (LIMS) questionnaire 172

r. The system includes an incident tracking system for recording, investigating, and managing safety and accident
violations in the laboratory.

s. The system monitors proficiency test assignment, completion, and casework qualification for analytical staff.

t. The system includes revenue management functionality, including profitability analysis.

u. The system provides analysis tools to better support laboratory functions like resource planning, productivity
projections, workload distribution, and work scheduling, and those tools display information in a consolidated
view, with the ability to drill down to more detailed data.

v. The system calculates administrative and lab costs.

w. The system captures and maintains patient, submitter, supplier, and other client demographics and billing
information for costing, invoicing, collecting, reporting, and other billing activities.

x. The system supports multiple customer payment sources (e.g. grants).

y. The system tracks number of visits per specific industry.

1.5 System-specific
The system-specific addendum can be found here.

1.6 Industry-specific
The industry-specific addendum can be found here.

1.7 Custom requirements

1.7 Custom requirements

Request for information Requirement code Vendor response

a.

b.

c.

d.

e.

f.

g.

h.

i.

h.

i.

j.
Laboratory information management system (LIMS) questionnaire 173

References
[1] https:/ / www. mediawiki. org/ wiki/ Extension:Collection

Laboratory information system (LIS)

questionnaire
The intention of this document is 1. to assist clinical and public health laboratories searching for a laboratory
information system (LIS) with identifying their system needs and 2. to help labs better determine if a specific
vendor/product meets their requirements in the form of a request for information (RFI). The idea is to allow users to
incorporate a standardized specifications sheet in their comparison of various LIS products.
This questionnaire lists the extensive requirements of an LIS. (For a laboratory information management system
(LIMS, see the LIMS questionnaire.) The questionnaire is organized such that sections 1.0 through 1.4 the
requirements of most any LIS, including special requirements for facilities managing public health, corrections
facility, or blood bank data.
This questionnaire attempts to be comprehensive and includes many items that do not apply to every lab.
Additionally, some laboratories' requirements include a functionality item not common to other labs. The last
section, 1.5 "Custom functions," is designed for the vendor to insert any additional functionality that doesn't fall
under the categories provided.
When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g.
1.4.2.f for "The system allows the administrator to create custom screens, applications, and reports."

Requirement code and notes

In responding to each requirement, the vendor must select a requirement code from the following:
Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
N: Does not meet requirement
I: Informational response only, N/A
The vendor should ideally enter a requirement code and a response for each functionality question.

Printing or saving
The print/export options in the navigation on the far left give you a few options for saving this and other pages,
printing them for later.
Note: Tables are currently not being rendered in PDFs as we like through the MediaWiki Collection extension [1].
While we sure would love for you to make a PDF of this document, be warned: the tables don't format as intended,
using either the "Create a book" or "Download as PDF" processes. For now you're best off selecting "Printable
version" and printing that instead.
Laboratory information system (LIS) questionnaire 174

1.0 Vendor information

1.0 Vendor information

Company name

Physical address

Website

LIMSwiki web page

Contact name and title

Contact e-mail

Contact phone and fax

Years in business

1.1 Vendor services

1.1 Vendor services

Request for information Requirement Vendor

code response

a. The vendor offers an online and/or on-site demonstration.

b. The vendor provides a detailed project plan that includes the project team, timeline, deliverables, and risk and
issue management procedures.

c. The vendor explains their overall project approach, deliverables, time constraints, and any other criteria for the
project.

d. The vendor provides reliable cost estimates and pricing schedules, including all products and services in the
scope of work.

e. The vendor details the amount of time and staff that the purchaser will have to provide for the implementation
process.

f. The vendor can explain the maintenance and support offered during and after implementation, including times
and methods of availability, issue escalation and management, etc.

g. The vendor provides a support schedule for the implementation process, including optional support levels,
their function, and availability.

h. The vendor provides support during the "go-live" period between system validation/operational deployment
and final acceptance/beginning of maintenance and support agreements.

i. The vendor provides a gap analysis after initial system installation, identifying the deliverables or tasks
remaining.

j. The vendor provides a table linking each deliverable to the corresponding user requirement specification it
fulfills.

k. The vendor uses a consistent training methodology for educating new users.

l. The vendor supplies LIS-specific training program curricula.

m. The vendor provides user, administrator, developer, installation, and reference manuals.

n. The vendor provides design qualification documentation.

o. The vendor provides installation qualification documentation.

p. The vendor provides operation qualification documentation.

q. The vendor provides performance qualification documentation during implementation.

Laboratory information system (LIS) questionnaire 175

r. The vendor provides well-documented system upgrades that authorized users can independently install.

s. The vendor provides source code for the system.

t. The vendor provides an optional comprehensive set of test codes suitable for use by the purchaser.

1.2 Information technology

1.2.1 General IT

1.2.1 General IT

Request for information Requirement Vendor

code response

a. The system operates with a traditional client-server architecture, with software installed on each machine that
needs to access the system.

b. The system operates with a web-based interface, hosted on a server and accessed via a web browser on most
any machine.

c. The system contains a single, centralized database that supports multiple sites and departments.

d. The system's database conforms to the Open Database Connectivity Standard (ODBC).

e. The system is designed so upgrades to the back-end database do not require extensive reconfiguration or
effectively cripple the system.

f. The system is designed to not be impacted by multiple users or failover processes.

g. The system applies security features to all system files.

h. The system applies log-in security to all servers and workstations accessing it.

i. The system provides a workstation and server authentication mechanism.

j. The system applies Secured Socket Layer (SSL) encryption on the web client interface.

k. The system encrypts client passwords in a database, with support for multi-case and special characters.

l. The system uses TCP/IP as its network transport.

m. The system provides data archiving functionality, including a configurable scheduled archive, for all contained
data, without requiring an off-line mode or human interaction with the data to be archived.

n. The system allows automated backup and restore capability without support intervention, as well as manual
backups.

o. The system maintains the transactional history of system administrators.

p. The system maintains an analyst communication log, accessible by the administrator.

1.2.2 Hardware environment

Laboratory information system (LIS) questionnaire 176

1.2.2 Hardware environment

Request for information Requirement code Vendor response

a. The system proves compatible with a variety of hardware environments.

b. The system can be utilized with a touch-screen.

1.2.3 Software environment

1.2.3 Software environment

Request for information Requirement code Vendor response

a. The system proves compatible with a variety of software environments.

b. The system utilizes a non-proprietary database such as Oracle or Microsoft SQL Server.

1.3 Regulatory compliance and security

1.3.1 Regulatory compliance

1.3.1 Regulatory compliance

Request for information Requirement Vendor

code response

a. The system supports 21 CFR Part 11 and 40 CFR Part 3 requirements, including login security, settable
automatic logouts, periodic requirements for mandatory password changes, limits on reusability of passwords, and
full electronic signature.

b. The system supports ISO/IEC 17025 requirements.

c. The system supports HIPAA requirements.

d. The system supports GALP and/or GAMP standards.

e. The system supports the standards of The NELAC Institute.

f. The system supports AABB (American Association of Blood Banks), College of American Pathologists, (CAP),
The Joint Commission (TJC), and/or any additional requirements or standards.

g. The system meets government requirements for handling classified information and documents.

h. The system can create reports for and route samples to the Centers for Disease Control and Prevention (CDC),
Food and Drug Administrations (FDA), Environmental Protection Agency (EPA), and other contract laboratories.

i. The system maintains audit and specification violation trails of all data manipulation such as result and header
information changes as consistent with all applicable regulations and standards.

j. The system maintains audit trails at least as long as the records to which they pertain.

k. The system's audit log retains all data, prohibits any deletions, allows user comments, and allows reporting of
contained information.

l. The system provides additional persistent auditing capabilities, such as the audit of cancelled tests and scheduled
system functions.

m. The system provides user-selectable NELAP-compliant internal chain of custody that tracks all specimens and
associated containers from the time they are collected until disposed of.

n. The system provides the ability to insert/manage secure electronic and/or digital signatures.

o. The system incorporates automatic date and time stamping of additions, changes, etc.

p. The system can automatically validate and approve data prior to being moved to the main database.
Laboratory information system (LIS) questionnaire 177

1.3.2 Security

1.3.2 Security

Request for information Requirement Vendor

code response

a. The system allows administrators and other authorized users to configure multiple levels of user rights and
security by site location, department, group, role, and/or specific function.

b. The system allows administrators and users to reset user passwords.

c. The system features and enforces adjustable rules concerning password complexity, reuse, and expiration.

d. The system can lock a user out after a specified number of consecutive failed log-in attempts.

e. The system provides the option for automatic user logout based on keyboard or mouse inactivity.

f. The system makes authority checks to ensure only authorized individuals can use the system to perform an
operation.

g. The system allows authorized users to modify records, while also maintaining an audit trail of such actions.

h. The system allows authorized users to manually delete records, while also maintaining an audit trail of such
actions.

i. The system prompts users to declare a reason for making changes to or deleting data in the system.

j. The system provides email notification of lockout, security access, and improper workstation access.

k. The system provides a mechanism to allow a user read-only access to stored data.

l. The system allows authorized users to generate a detailed user access record.

m. The system allows authorized users to review audit logs at will.

n. The system allows authorized users to query and print chain of custody for items, cases, projects, and batches.

o. The system allows supervisors to override chain of custody.

p. The system automatically tracks when supervisors review critical result values.

q. The system allows automatic and/or manual holds or locks to be placed on data to ensure it goes unaltered or
remains retrievable during a retention period.

r. The system can first feed data from connected non-CFR-compliant instruments through a virtual environment
that is compliant (audit trailed, secure, versioned, etc.) before being stored.

s. The system can control whether users are able to export data to portable long-term storage media like a USB
flash drive or recordable DVD.

t. The system employs automatic file encryption on stored data.

u. The system employs checks to enforce permitted sequencing of steps and events.

v. The system allows multiple users to connect simultaneously to a contract lab.

w. The system provides read-only access to contract laboratory results.

x. The system prohibits issuing reports outside of qualified areas while also allowing reports to be viewed locally
or remotely based on security application limits and/or specimen ownership.
Laboratory information system (LIS) questionnaire 178

1.4 General system functions

1.4.1 General functions

1.4.1 General functions

Request for information Requirement Vendor

code response

a. The system offers non-LIS trained personnel the ability to easily access system data via an intuitive, user-friendly
Windows-type graphical user interface (GUI) which permits the display of data from specimen points, projects, and
user-defined queries, and can be configured to language, character set, and time zone needs.

b. The system allows authorized users to configure their GUI to a specific language, character set, and time zone.

c. The system permits remote access for users, system admins, and support agents.

d. The system allows for the use of navigation keys to freely move from field to field.

e. The system allows tabular data to be sorted and filtered.

f. The system can send on-screen output to a printer or file without contradicting view-only statuses.

g. The system provides single data entry, automatically populates other data fields, and remembers pertinent and
relevant data so it doesn't need to be re-entered, selected, or searched for.

h. The system eliminates (or significantly reduces) redundant data entry and paper trails.

i. The system contains one or more spell-check dictionaries that allow authorized users to add, edit, or remove
entries.

j. The system provides full database keyword and field search capability, including the use of multiple search
criteria.

k. The system includes the ability to search multiple databases, including those containing legacy data.

l. The system allows users to build, save, and edit queries for future use.

m. The system can automate the search for and extraction of pertinent data, including the export of that data to
external applications for additional processing and calculation.

n. The system cleanly converts migrated data to allow for reporting of historical specimen collections.

o. The system allows for the specification of a retention period for captured data and can enact it based on
date-based fields or a future event.

p. The system can manage and store both sample- and non-sample-related data, including images from microscopes,
GCMS scans of peaks, PDF files, spreadsheets, or even raw data files from instrument runs for later processing.

q. The system can manage and store media objects like digital photos, bitmaps, movies, and audio files.

r. The system issues sequential numbers for chain of custody.

s. The system's numbering scheme allows for sub-numbering while maintaining parent-child relationships.

t. The system efficiently utilizes standardized data input points and enhanced individual workload tracking.

u. The system captures data from all laboratory processes, ensuring uniformity of statistical reporting and other
electronic data shared with designated users of the data.

v. The system can link objects to other objects, e.g. linking a standard operating procedure (SOP) to a test result.

w. The system notifies users of events like the scheduling, receipt, and completion of tasks.

x. The system includes the ability to set up alerts via email.

y. The system has real-time messaging capabilities, including instant messaging to one or more users.

z. The system supports the use of a voice recognition system (for navigation or transcription) or has that
functionality.

aa. The system offers integrated or online user help screens.

Laboratory information system (LIS) questionnaire 179

ab. The system includes clinical trial management tools.

ac. The system can handle patient case management and assignment.

ad. The system provides physician, clinic, and contract lab management tools.

ae. The system provides outreach and call list management tools.

af. The system supports multi-site, multi-lab, or multi-physician groups.

ag. The system provides disease tracking functionality.

ah. The system monitors turnaround time, from test request to clinician review.

ai. The system is veterinary-compatible.

1.4.2 Configuration and customization

1.4.2 Configuration and customization

Request for information Requirement Vendor

code response

a. The system can be configured to meet the workflow of a laboratory without additional programming.

b. The system architecture is modular or extensible and can easily and efficiently be modified to facilitate the
addition of new functionality as business needs change.

c. The system has an application programming interface (API) or a similar software development toolkit (SDK). If
web-based, the API should support Simple Object Access Protocol (SOAP), representational state transfer (REST),
or both.

d. The system can expand to accommodate a new discipline.

e. The system supports customized screens with user-definable information specific to a customer, department,
analysis, etc.

f. The system allows the administrator to create custom screens, applications, and reports.

g. The system permits users to create templates and worksheets for standardizing analysis pages, patient pages, test
ordering pages, and/or the reporting processes.

h. The system allows a user to independently add fields without requiring reconfiguration of the system, even after
routine upgrades and maintenance.

i. The system allows a user to independently add universal fields on all specimens logged into the system at any
time during or after implementation, while neither voiding the warranty nor requiring vendor review at a later date.

j. The system provides flexible and customizable mapping dictionaries for interconversion of different standards
and more.

k. The system supports the definition and maintenance of edit tables and lists.

l. The system supports customizable test, panel, and profile libraries.

m. The system supports customization of test pick lists based on specialty utilization.

n. The system dynamically changes captions (labels) on system fields.

o. The system has dynamically configurable limit periods and notification hierarchy.

p. The system provides optional configuration choices for correctional facilities.

q. The system provides optional configuration choices for biobanks and blood banks.

r. The system allows for the integration of additional printers and scanners both locally and externally.
Laboratory information system (LIS) questionnaire 180

1.4.3 Receiving and scheduling

1.4.3 Receiving and scheduling

Request for information Requirement Vendor

code response

a. The system tracks status and workflow of the accession throughout the laboratory lifecycle, from submission to
final analysis, including receiving, diagnostic testing, diagnostic test result reporting, and billing.

b. The system supports barcoded specimen labeling and tracking.

c. The system allows users to create, manage, and track viewable specimen container schemata.

d. The system creates and maintains a unique electronic accession record for each accession received.

e. The system supports standard-format digital picture and document upload and attachment to electronic accession
records.

f. The system supports a user-configurable, spreadsheet-style, templated multi-specimen (batch) login without
requiring additional programming.

g. The system features order entry rules for better managing duplicate orders, rejecting inappropriate tests,
identifying inappropriate containers, rerouting tests to outside labs, etc.

h. The system supports the modification of specimen or specimen batch information prior to actual multi-specimen
(batch) login.

i. The system supports ad-hoc specimens not predefined in the specimen point list during multi-specimen (batch)
login.

j. The system creates, saves, and recalls pre-login groups for routine specimens to simplify recurring logins.

k. The system streamlines the login of recurring specimen projects.

l. The system allows standing orders and test schedules to be defined for future orders.

m. The system automatically generates labels for recurring specimens and specimen groups.

n. The system can automatically split and manage orders requiring multiple testing locations.

o. The system can differentiate "investigation use only" and "research use only" tests.

p. The system can automatically generate and manage administrative documents for genetics tests.

q. The system allows authorized users to generate user-definable or rules-based chain of custodies, worksheets,
routing sheets, and custom labels upon specimen login.

r. The system provides a comprehensive view of all specimens and projects in the system using a color-coded
status view of the current and scheduled specimens via user-configurable templates, all without requiring
additional programming.

s. The system includes environmental monitoring (EM) functionality or integrates with an external EM product.

t. The system prevents a specimen from being placed in a report queue until approved.

u. The system includes comprehensive scheduling, tracking, and flow management of specimens, including across
multiple sites.

v. The system is capable of geographically organizing specimen records and their associated tests for special
analysis and reporting.

w. The system allows authorized users to accept, cancel, re-run, and override attributes of one or multiple tests for
a given patient.

x. The system allows authorized users to review the available test types in the system, including their reference
range and units of measure.

y. The system allows multiple diagnosis codes to be attached to an ordered test.

z. The system has a "miscellaneous" test code to allow a test undefined in the system to be ordered and billed.
Laboratory information system (LIS) questionnaire 181

aa. The system automatically runs medical necessity checks (based on diagnosis codes) on a requested test.

ab. The system automatically makes duplicate order checks and notifies applicable users upon detection.

ac. The system can import and utilize the Centers for Medicare and Medicaid Services' (CMS') National and Local
Coverage Determinations files.

ad. The system can track and manage advance beneficiary notices (ABNs) from CMS as needed.

ae. The system allows authorized users to schedule routine specimens on an hourly, daily, weekly, or monthly
basis, allowing them to be enabled and disabled as a group.

af. The system generates an hourly, daily, weekly, or monthly specimen collection schedule from a scheduling
database.

ag. The system schedules and assign tasks based on available inventory and personnel.

ah. The system supports automatic assignment and scheduling of analysis requests.

ai. The system receives accession/analysis request information from web-enabled forms.

aj. The system electronically receives and processes collection and analysis request information and schedules
from third parties.

ak. The system can capture and store patient demographics, risk factors, and epidemiology data such as exposure
data from third-party test requests.

al. The system has an inter-lab transfer function.

am. The system processes automated uploading of field-derived specimen collection data.

an. The system allows users to handle billable and non-billable tests on the same accession.

ao. The system supports tracking of shipping and receiving.

1.4.4 Analysis and data entry

1.4.4 Analysis and data entry

Request for information Requirement Vendor

code response

a. The system supports a variety of test protocols, each capable of storing test comments, test required, and special
information like GCMS conditions or special objects associated with the test.

b. The system provides and enforces normal data range values for diagnostic tests.

c. The system includes default input values for diagnostic tests.

d. The system provides for a single test code requiring multiple analytes as targets.

e. The system allows authorized users to make a test code inactive across one or more sites while retaining it for
audit and reporting purposes.

f. The system limits test code authorization to only qualified personnel and maintains their certification(s) to run
assigned tests.

g. The system supports and qualifies text-based tests.

h. The system supports single-component tests such as pH, BOD, CD, etc.

i. The system allows users to specify a single-component, multi-component, or narrative text test or group of tests,
which represent all tests required.

j. The system can effectively manage complex molecular testing protocols.

k. The system can effectively manage genetic testing protocols.

l. The system can effectively manage histology and cytology testing protocols.

m. The system allows for user-definable and procedure-specific protocols for HIV specimens.
Laboratory information system (LIS) questionnaire 182

n. The system permits user-generated and modifiable calculations (based on a formulaic language) to be applied to
all tests.

o. The system distinguishes between routine and duplicate analysis.

p. The system provides an overview of all outstanding tests/analyses for better coordination of work schedules.

q. The system notifies analysts of applicable safety hazards associated with a specimen, reagent, or test before
testing begins.

r. The system electronically transfers an item during testing from one functional area to another.

s. The system's user interface displays visual indicators such as status icons to indicate a specimen's status in the
workflow.

t. The system allows file transfer of data from instruments via intelligent interfaces or multi-specimen/multi-test
ASCII files, with full on-screen review prior to database commitment.

u. The system permits manual data entry into an electronic worksheet of test measurements and results.

v. The system allows incorrectly inputted data to be manually corrected.

w. The system prevents out-of-range and other critical results from being posted as final.

x. The system provides colored visual indication of previously entered data as well as new data associated with a
single specimen when a result is entered, with the indicator changing color if the value is out of specification.

y. The system allows automated or semi-automated data insertion.

z. The system stores non-narrative textual results in searchable fields.

1.4.5 Post-analysis and validation

1.4.5 Post-analysis and validation

Request for information Requirement Vendor

code response

a. The system updates specimen/item status when tests are completed.

b. The system automatically reorders a test or orders additional tests if results don't meet lab-defined criteria,
especially when the original specimen is still available.

c. The system can record test results in or map them to the Systematized Nomenclature of Medicine Clinical Terms
(SNOMED CT) and/or Logical Observation Identifiers Names and Codes (LOINC) standards.

d. The system reads results from previously entered tests to calculate a final result and immediately displays the
calculated result.

e. The system allows authorized users to review all analytical results, including pricing, spec violations, history or
trend analysis by analyte, and comments.

f. The system graphically displays the results of one or more tests in a graph (normalized or otherwise) for the
purpose of visualizing data or searching for possible trends.

g. The system provides tools for graphical patient and analyte trend plotting.

h. The system allows on-screen review of the stored test result, diluted result with corrected method detection limits
(MDLs), and qualifiers after running specimens for multiple dilutions as in gas chromatographymass spectrometry
(GC-MS).

i. The system includes data mining tools for model learning, evaluation, and usage.

j. The system displays the standard operating procedure (SOP) associated with each test result to ensure proper
techniques were used.

k. The system stores test-related analysis comments with the test.

l. The system provides auto-commenting for common laboratory result comments.

Laboratory information system (LIS) questionnaire 183

m. The system is capable of displaying entered order and test comments as an onscreen alert for testing and other
personnel.

n. The system provides for high-volume multi-component transfers of test results, with the ability to automatically
match specimens to data files in either a backlog mode or a designated file mode, to parse the data, and to review
and commit the specimen data.

o. The system's results validation process accesses all information about a specimen or group of specimens,
including comments or special information about the specimen.

p. The system's results validation process checks each result against its individual specimen location specifications
(both warning and specification limits).

q. The system supports validation at the analysis and specimen level, while also prohibiting specimen validation
when analysis validation is incomplete.

r. The system uses a menu-driven process for results validation.

s. The system provides secure electronic peer review of results.

t. The system clearly differentiates released preliminary data from fully validated results.

u. The system validates/approves data prior to being moved to the main database.

v. The system can hold all test results on a specimen with multiple tests ordered on it until all work is completed
and a final report is issued.

w. The system fully manages all aspects of laboratory quality control, including the reporting and charting of all
quality control data captured in the lab.

x. The system provides a base for a quality assurance program, including proficiency testing, scheduled
maintenance of equipment, etc.

y. The system distinguishes QA/QC duplicates from normal specimens.

z. The system allows QA/QC tests to be easily created and associated with the primary analytical test.

aa. The system allows manual entry of QA and QC data not captured as part of the system's regular processes.

ab. The system calculates monthly QA/QC percentages for testing.

ac. The system automatically flags out-of-range quality control limits.

ad. The system is able to flag results for aspects other than being out-of-range, including testing location, patient
age, etc.

ae. The system is able to automatically report any diagnostic test results deemed "suspect" or "positive" for
reportable diseases.

af. The system checks data files for specification and corrects them for specific reporting and analyte limits and
qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting.

1.4.6 Instruments
Laboratory information system (LIS) questionnaire 184

1.4.6 Instruments

Request for information Requirement Vendor

code response

a. The system bilaterally interfaces with instruments and related software.

b. The system downloads data directly from laboratory instruments.

c. The system permits the defining and exporting of sequences to instruments.

d. The system tracks and reports on the usage of attached laboratory instruments.

e. The system allows automatic or manual reservation/scheduling of laboratory instruments.

f. The system automatically (or manually allow an authorized user to) removes an instrument from potential use
when it falls out of tolerance limit or requires scheduled calibration.

g. The system provides a database of preventative maintenance, calibration, and repair records for laboratory
equipment, preferably supported by standardized reporting.

h. The system schedules calibration, verification, and maintenance tasks in the worksheets or work flow process
and make that schedule available for viewing.

i. The system allows users to create and edit instrument maintenance profiles.

1.4.7 External system interfaces

1.4.7 External system interfaces

Request for information Requirement Vendor

code response

a. The system supports a library of common electronic data deliverable (EDD) formats.

b. The system transfers data to and from another record management system.

c. The system integrates with Microsoft Exchange services.

d. The system imports data from and exports data to Microsoft Word, Excel, and/or Access.

e. The system can interface with non-Microsoft programs.

f. The system interfaces with external billing systems.

g. The system interfaces with electronic medical record or electronic health record systems.

h. The system interfaces with hospital information systems.

i. The system interfaces with enterprise resource planning (ERP) systems.

j. The system interfaces with external contract or reference laboratories to electronically send or retrieve
datasheets, analysis reports, and other related information.

k. The system exchanges data with National Identification System (NAIS) tracking systems.

l. The system generates and exchanges data with other systems using Health Level 7 (HL7) standards.

m. The system leverages the application programming interface (API) of other systems to establish integration
between systems.

n. The system provides a real-time interface for viewing live and stored data transactions and errors generated
by interfaced instruments and systems.

o. The system transmits status changes of specimens, inventory, equipment, etc. to an external system.

p. The system directs output from ad-hoc queries to a computer file for subsequent analysis by other software.

q. The system supports the manual retransmission of data to interfaced systems.

Laboratory information system (LIS) questionnaire 185

r. The system supports dockable mobile devices and handle information exchange between them and the
system.

s. The system supports the use of optical character recognition (OCR) software.

1.4.8 Reporting

1.4.8 Reporting

Request for information Requirement Vendor

code response

a. The system includes a versatile report writer and forms generator that can generate reports from any data in tables.

b. The system includes a custom graphic generator for forms.

c. The system interfaces with a third-party reporting application.

d. The system allows the development of custom templates for different types of reports.

e. The system maintains template versions and renditions, allowing management and tracking of the template over
time.

f. The system generates template letters for semi-annual reports.

g. The system supports report queries by fields/keys, status, completion, or other variables.

h. The system use Microsoft Office tools for formatting reports.

i. The system supports multiple web browsers for viewing online reports.

j. The system generates, stores, reproduces, and displays laboratory, statistical, and inventory reports on demand,
including narrative.

k. The system includes several standard reports and query routines to access all specimens with the pending status
through a backlog report that includes the following criteria: all laboratory, department, analysis, submission date,
collection date, prep test complete, location, project, specimen delivery group, and other user-selectable options.

l. The system indicates whether a report is preliminary, amended, corrected, or final while retaining revision history.

m. The system supports both structured and synoptic reporting.

n. The system generates management and turn-around time reports and graphs.

o. The system generates customized final reports.

p. The system automatically generates laboratory reports of findings and other written documents.

q. The system automatically generates individual and aggregate workload and productivity reports on all operational
and administrative activities.

r. The system automatically generates and transmits exception trails and exception reports for all entered and/or
stored out-of-specification data.

s. The system generates a read-only progress report that allows for printed reports of specimen status and data
collected to date.

t. The system provides an ad-hoc web reporting interface to report on user-selected criteria.

u. The system automatically generates and updates control charts.

v. The system generates QA/QC charts for all recovery, precision, and lab control specimens via a full statistics
package, including Levy-Jennings plots and Westgard multi-rule.

w. The system displays history of previous results for an analyte's specimen point in a tabular report, graphic trend
chart, and statistical summary.

x. The system automatically generates and posts periodic static summary reports on an internal web server.

y. The system transmits results in a variety of ways including fax, e-mail, print, and website in formats like RTF,
PDF, HTML, XML, DOC, XLS, and TXT.
Laboratory information system (LIS) questionnaire 186

z. The system electronically transmits results via final report only when all case reviews have been completed by the
case coordinator.

aa. The system includes a rules engine to determine the recipients of reports and other documents based on definable
parameters.

ab. The system allows database access using user-friendly report writing and inquiry tools.

ac. The system supports automatic reporting to the state based on state-level health department rules.

ad. The system reports molecular results in both clinical and anatomical pathology environments.

ae. The system can produce specialized reports for microbiology, hematology, assay trend, and/or cardiac risk.

af. The system can produce epidemiology and antibiogram reports.

ag. The system provides the tools for creating and maintaining licensing, proficiency testing, inspection, and
regulatory records and reports.

1.4.9 Laboratory management

1.4.9 Laboratory management

Request for information Requirement Vendor

code response

a. The system allows the creation, modification, and duplication of user profiles.

b. The system allows entry, maintenance, and administration of patient records and is able to track multiple patient
encounters.

c. The system allows entry, maintenance, and administration of customers, suppliers, and other outside entities.

d. The system allows patients, customers, suppliers, physicians, and other such entities to be flagged as either active
or inactive.

e. The system allows the creation, modification, and maintenance of user training records and associated training
materials.

f. The system supports the ability to set up separate security, inventory, reporting, etc. profiles across multiple
facilities.

g. The system allows the management of information workflow, including notifications for requests and exigencies.

h. The system allows the management of documents like SOPs, MSDS, etc. to better ensure they are current and
traceable.

i. The system allows the management and monitoring of resources by analyst, priority, analysis, and instrument.

j. The system allows authorized persons to select and assign tasks by analysts, work group, instrument, test,
specimen, and priority.

k. The system allows authorized persons to review unassigned work by discipline and by lab.

l. The system allows authorized persons to review pending work by analyst prior to assigning additional work.

m. The system manages and reports on reference specimens, reagents, and other inventory, including by
department.

n. The system automatically warns specified users when inventory counts reach a definable threshold and either
prompt for or process a reorder.

o. The system allows authorized users to monitor and report on reference and reagent creation, use, and expiration.

p. The system allows authorized users to search invoice information by invoice number, account number,
accession, payment types, client, or requested diagnostic test(s).

q. The system includes performance assessment tracking.

Laboratory information system (LIS) questionnaire 187

r. The system receives, records, and maintains customer and employee feedback and applies tools to track the
investigation, resolution, and success of any necessary corrective action.

s. The system includes an incident tracking system for recording, investigating, and managing safety and accident
violations in the laboratory.

t. The system monitors proficiency test assignment, completion, and casework qualification for analytical staff.

u. The system includes revenue management functionality, including medical necessity checks and profitability
analysis.

v. The system provides analysis tools to better support laboratory functions like resource planning, productivity
projections, workload distribution, and work scheduling, and those tools display information in a consolidated
view, with the ability to drill down to more detailed data.

w. The system calculates administrative and lab costs.

x. The system captures and maintains patient, submitter, supplier, and other client demographics and billing
information for costing, invoicing, collecting, reporting, and other billing activities.

y. The system supports multiple customer payment sources (e.g. grants).

z. The system supports multi-tiered pricing based on patient type and location.

aa. The system tracks number of visits per specific industry.

1.5 Custom requirements

1.7 Custom requirements

Request for information Requirement code Vendor response

a.

b.

c.

d.

e.

f.

g.

h.

i.

h.

i.

j.
 188

8. Laboratory Informatics Vendor Directory

Key laboratory informatics vendors and software

This information used to appear on the front page of the wiki. As of November 2015, it has been transitioned to a
single page to provide more space for the front page.

Key laboratory informatics vendors

Key commercial laboratory informatics vendors

What does it mean to be "key" for the purpose of this ranking? The criterion for a vendor selling proprietary
commercial laboratory informatics software being listed here: the vendor's LIMSwiki page must have a cited (from a
publicly-available source) price list. Those with demonstration videos are given higher preference; items ranked by
number of videos. Go here for all listed vendors in the wiki.

1. LabLynx, Inc. 16. Agilent Technologies, Inc. 31. Promium, LLC

2. Two Fold Software Limited
3. BioData Inc.
4. Scilligence Corporation
5. labfolder GmbH
6. LabArchives, LLC
7. LabLite, LLC
8. Research Innovations
Limited
9. Biomatters Ltd.
10. eBioSys Pty. Ltd.
11. Thermo Scientific
12. AgileBio
13. Mestrelab Research S.L.
14. Autoscribe Ltd.
15. LabVantage Solutions, Inc.
17. Instrumentos Cientficos SA
18. BiochemLab Solutions
19. NoteBookMaker, LLC
20. Sysment Kft.
21. The Edge Software Consultancy
Ltd.
22. BioSistemika LLC
23. LABTrack, LLC
24. Blaze Systems Corporation
25. ChemWare, Inc.
26. CloudLIMS.com, LLC
27. Dynamic Databases, LLC
28. EZQuant Ltd.
29. LabWare, Inc.
30. Laucks Technical Services, LLC
32. STARLIMS Corporation
33. ChemBytes
34. Findings Software SAS
35. FORMULATOR Software, LLC
36. Genetic Technologies, Inc.
37. Mountain States Consulting, LLC
38. Nippon Control System
Corporation
39. shazino SAS
40. SLCLAB Informtica SL
41. SPLhost, Inc.
42. Summit Research Services
43. Terra Systems O

Key cloud-based and open-source laboratory informatics software

Key cloud- or SaaS-based laboratory informatics software

Key laboratory informatics vendors and software 189

Listed below are key commercial and open-source laboratory informatics software offerings listed in the wiki that
utilize the cloud or software as a service (SaaS) model. "Key" indicates vendor's (or software's) LIMSwiki page
has a cited (from a publicly-available source) price list. Those with demonstration videos are given higher
preference; items ranked by number of videos.

1. LabKey Server via LabKey Corporation
2. webLIMS and Health Cloud Hub via LabLynx,
Inc.
3. Bika LIMS via Bika Lab Systems (Pty) Ltd.
4. Labguru via BioData Inc.
5. Scilligence ELN via Scilligence Corporation
6. labfolder via labfolder GmbH
7. LabArchives via LabArchives, LLC
8. eCAT via Research Innovations Limited
9. Mbook via Mestrelab Research S.L.
10. LabVantage 7 via LabVantage Solutions, Inc.
11. NevisLIMS via Instrumentos Cientficos SA
12. NoteBookMaker via NoteBookMaker, LLC
13. Sysment Notebook via Sysment Kft.
14. BioRails DM via The Edge Software Consultancy
Ltd.
15. GENEIO via BioSistemika LLC
16. LABTrack via LABTrack, LLC
17. BioTracer via CloudLIMS.com, LLC
18. limsExpress via Dynamic Databases, LLC
19. iLIS via Margy Tech Pvt. Ltd.
20. SimpLabo via Nippon Control System Corporation
21. Element LIMS via Promium, LLC
22. Datacloud via SPLhost, Inc.
23. hivebench via shazino SAS

Open-source laboratory informatics software

Listed below are some of the most active and supported open-source laboratory informatics software projects with articles in the wiki, as
of December 2015. Go here for all listed open-source laboratory informatics projects.

Bika LIMS via Bika Lab Systems
LabKey Server via LabKey Corporation
Galaxy via Penn State & Emory University
GNomEx via Huntsman Cancer Institute
BASE via the Lund BASE team
OSCAR via OSCAR EMR
OpenClinica via OpenClinica, LLC
eLabFTW via its developer Nicolas CARPi
open enventory via Technische Universitt Kaiserslautern
OpenMRS via its dev team
SeqWare via its dev team
eln via its developer Daniel Wagenaar
openBIS via Center for Information Science and Databases - ETHZ
OpenSpecimen via Krishagni Solutions
OpenEMR via its dev team
Indigo ELN via GGA Software Services, LLC
OpenChrom via its dev team
GNU Health via GNU Solidario
openCDMS via University of Manchester
OpenELIS via Univ. of Iowa and Univ. of Washington
LabTrove via University of Southampton
LIMS vendor 190

LIMS vendor
Looking for clinical- or hospital-based informatics systems? You may want to also check out the LIS vendor page.

Before adding a specific vendor or product to LIMSwiki, please review the LIMSWiki:Vendor page and LIMSWiki:Product page articles
respectively.
They explain the general guidelines that should be followed when creating such pages.

A LIMS vendor is an entity (business, company, corporation, etc.) which provides laboratory information
management system (LIMS) software or software packages. The LIMS software may be very generalized to handle a
great number of laboratory situations, or it may be very specific to handle the needs of a certain field of study. Of
course, every LIMS may have a different feature set based upon its intended focus.

Active LIMS vendors

To find LIMS vendors by the industry or industries they serve, please see the categorical organization tool LIMS vendors by industry.

Note: The columns of this table are sortable for your convenience. Simply click the small arrows in the
title of each column to use this feature. Additionally, if you wish to sort by column X and then column
Y, simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and
left-click the desired arrow for the second column to sort by.

Vendor Key LIMS offering(s) Headquarters Additional notes

(Country)

10BioSystems, LLC LabCentral United States

2nd Sight Solutions OhNo! Canada

3rd Millennium, Inc. ARDAS United States

AAC Infotray AG Limsophy LIMS Switzerland

ABB Ltd. CCLAS, Knowledge Manager United States

Accusoft CC AccuLIMS South Africa

Adifo NV BESTMIX LIMS Belgium Former product Laboras now seems

defunct.

Advanced Business Software PHIMS United States

Advanced Technical Software uniLIME Austria Former product q/LIME seems no

longer supported.

Advanced Technology Corp. VADDS, VETSTAR United States

Agaram Technologies Pvt. Ltd. QuaLIS India

AgiLab SAS AgiLIMS France

AgileBio LabCollector United States

Agilent Technologies, Inc. LimsLink United States

AHP GmbH iQ-LIMS Germany

LIMS vendor 191

AJ Blomesystem GmbH LABbase, readyLIMS Germany FIVAS, LABcua, and LABpharma

appear to no longer be offered as of
2013.
New readyLIMS appeared in 2012.

Alcor SPRL CI-Master, LabTec Belgium

Alpha Technologies US, LP ECLIPSE, Enterprise ULTIMA United States

Ambidata Digital Innovation Solutions & LabWay-LIMS Portugal

Consulting, Lda.

Analytical Information Systems, Ltd. AIS LIMS United Kingdom

arivis AG scarabLIMS Germany

ASI DataMyte, Inc. QDA United States Quality management software with a
LIMS module

ASM Soft SL ASM-LIMS Spain

Assaynet Inc. LIMS2010, LIMS.net Canada Previous name for LIMS2010 was
LIMS2003.

Asystance V.O.F. Alis LIMS Netherlands

ATGC Labs, LLC ActiveLIMS United States

Aurora Systems, Inc. VisuaLab United States

Autoscribe Ltd. Matrix Gemini United Kingdom North American distributor/support

team was Zumatrix, Inc.
until it was absorbed into new entity
Autoscribe Informatics Inc.

BARTELT GmbH datalabX Austria

Baytek International, Inc. MicroBLISS, WebBLISS, WebSQC, United States

WinBLISS

Baze Technology AS BazeLab LIMS Norway

Beijing Teleh Electronic Tech Co., Ltd. Bio-2000, TL LAB2000 China

BGASoft, Inc. LIMS ABC United States

Bika Lab Systems (Pty) Ltd. Bika LIMS South Africa [1]
Also available at SourceForge.net
under GPL.

Bio-Analytical Technologies Pvt. Ltd. BioClinical India

Bio-ITech BV eLabJournal LIMS The Netherlands

BioData Inc. Labguru United States Labguru replaced LabLife and

BioKM on December 5, 2011.

Biomatters Ltd. Geneious New Zealand

BioTeam Inc. MiniLIMS United States

Blaze Systems Corporation BlazeLIMS United States

LIMS vendor 192

Bode Technology Group, Inc. BodeLIMS United States

Broughton Software Ltd. LabHQ United Kingdom Was formerly SkySource Ltd.

Bruker Corporation SampleTrack United States

BTLIMS Technologies BTLIMS United States

Bytewize AB O3 LIMS, O3 LIMSXpress Sweden

Caliber Technologies Pvt. Ltd. CaliberLIMS, Caliber Pet-LIMS India Caliber Pet-LIMS was previously
Caliber Petro-LIMS.

Camin Cargo Control, Inc. POLARIS United States

Cargotrader, Inc. Cargotester.com United States

ChemWare, Inc. HORIZON Central United States

Chromasoft GmbH Lab21 LIMS Germany

Cimarron Software, Inc. SDK United States Cimarron creates custom LIMS
solutions
using a source development kit.

Civil Systems, Inc. CSi LIMS United States

Clinical Systems Ltd. ClinAxys II United Kingdom

CliniSys WinPath Enterprise United Kingdom

CliniSys Group Limited See vendors CliniSys and MIPS United Kingdom

CloudLIMS.com, LLC BioTracer United States

Clyde Computing Ltd. Q-SYS LIMS United Kingdom

Codon Software Private Limited Codon LIMS India

Columbia Energy & Environmental Services, OmniLIMS United States

Inc.

Common Cents Systems, Inc. ApolloLIMS United States Formerly marketed Cirrus and
M/LAB as preceding products

CompuDrug International, Inc. Laboratory Manager Plus United States

Computer Aid, Inc. HealthLIMS United States

Computer Sciences Corporation CSC LIMS United States

Computing Solutions, Inc. LabSoft LIMS United States

Comsense Datasystems of Australia ComLIMS Australia

Condition Monitoring International, LLC LabTrak United States

Contec Group International Ltd. MADCAP New Zealand

Core Informatics, LLC Core LIMS United States

Cosine Consultants Ltd. Fission LIMS Cyprus

LIMS vendor 193

CSS LIMS GmbH iLIMS Germany Changed company and product name
in January 2014.

Dassault Systmes SA Accelrys LIMS France Dassault acquired Accelrys, Inc. on

April 29, 2014.

Data Unlimited International, Inc. Starfruit CrimeLab, Starfruit DNA, United States
Starfruit GeneTell, Starfruit
IdentiTrack,
Starfruit Toxicology

Dataworks Development, Inc. Freezerworks United States

Desert Oasis Software Company, LLC ALIS United States

dialog EDV Systementwicklung GmbH diaLIMS Germany

DIPOLE SARL DipLABO France

Drishti-Soft Solutions Pvt. Ltd. cLIMS India

Dynamic Databases, LLC limsExpress United States

e-BiOnary Technologies Ltd. e-BiOData India

eBioSys Pty. Ltd. eLab Australia

ElmTree Systems, LLC ElmTree System United States

entimo AG PhaLIMS Germany

EPractice Corporation EPracticeLAB United States

EthoSoft, Inc. X-LIMS United States

Eusoft Srl EuSoft.Lab Italy

Finalist Software Noord Nederland C.V. FinaLims Netherlands

Forensic Advantage Systems Forensic Advantage United States A division of TCSC, Inc.

Frontier Science & Technology Research LDMS United States

Foundation, Inc.

Future Technologies, Inc. DNA LIMS United States

Genee Group, LLC LabScout LIMS United States

Genesis MicroSystems, Inc. LAB-2000 United States

Genetic Technologies, Inc. eDNA LIMS United States

Genial Genetic Solutions, Ltd. iGene, Shire United Kingdom

Genohm SA SLims Switzerland

GenoLogics Life Sciences Software Inc. Clarity LIMS Canada Geneus, Omix, and Proteus seem to
have been phased out in 2011.
GenoLogics LIMS was phased out in
2012, replaced by Clarity LIMS.

GoInformatics, Inc. GoLIMS United States

GQM mbH Qualifax LIMS Germany

GyroDimensions, Inc. BioInfoStream United States

LIMS vendor 194

H&A Scientific, Inc. IntelliLIMS, SLIM United States

Hach Company Hach WIMS United States,

Germany

Hamsoo IT Consultants Co. PetroLab Iran

HiTec Zang GmbH HiLIMS Germany

HM-Software HM-LIMS Germany

IBS AG CAQ=QSYS LIMS Germany

ICD. GmbH LABS/Q, LABS/QM, LABS/R Germany

iLab Solutions, LLC iLab Core Facility Management, United States

iLab Lab Materials Management

Illumina, Inc. Illumina LIMS United States

In Siliflo, Inc. In Siliflo LIMS United States

Indusoft OOO I-LDS LIMS Russia

Inflection Point Solutions, LLC PIMS United States

Infomed C.S. Lab@link Greece

Information Management Services, Inc. BSI, SEER*DMS United States

InfoTrak Pty. Ltd. InfoTrak Oil Australia Previous product name was Oil
Commander.

Innovatics Ky InnoLIMS Finland

Innovation Diagnostics, Inc. Lab Management System Canada

inray Industriesoftware GmbH WinLaisy Germany

Instem LSS Limited Provantis United Kingdom

Instrumentos Cientficos SA NevisLIMS Spain

Integromics SL OmicsHub, OmicsOffice Spain Former product was called ArrayHub

(now defunct)

Interface Engineering Co. Ltd. Nova-LIMS South Korea

Interpec Corporation INQAS, INTRACES United States

InterSystems Corporation TrakCare Lab United States

ISP Technologies SA Labmin South Africa

Jova Solutions Inc. FermWorks United States

JusticeTrax, Inc. LIMS-plus United States

jwConsulting GmbH jwLIMS Germany

K S Softech Pvt. Ltd. Lab Quest India

Khemia Software, Inc. Omega 11 LIMS United States

Kriti Microsystems Pvt. Ltd. Kriti LIMS India

KVANT spol. s r.o. Evidence Slovakia

Labage SA benchsys Belgium

LIMS vendor 195

LabCloud, Inc. LabCloud United States

LabKey Corporation LabKey Server United States

LabLite, LLC LabLite SQL LIMS United States

LabLogic Systems Limited Debra 5, PETra, Sara 5 United Kingdom

LabLynx, Inc. ELab, webLIMS United States

LabPro 2000 Ltd. LabPro, eQual New Zealand

Labsoft Tecnologia Ltda. myLIMS Brazil Not to be confused with Odysis SA's
myLIMS product.

LabVantage Solutions, Inc. LabVantage 7 United States Products formerly called SAPPHIRE
and SQL*LIMS.

LabWare, Inc. LabWare LIMS United States

Laucks Technical Services, LLC iLIMS United States

LETEC SARL Tetraed LIMS France

LGC Limited Kraken United Kingdom

LIMS at work GmbH Labmatica LIMS Germany

lims+WARE lims+WARE/ASP, United States

lims+WARE/Networks,
lims+WARE/Results,
lims+WARE/UNIX

LIMSCentral, LLC LIMSCentral United States

Limseo SARL Solution Laboratoire France

LINKSolutions SAA LINKS V3.3 LIMS Peru

Loc@soft Lims.net France

LTech Australia Pty. Ltd. Lims1 Australia

Lyons Information Systems, Inc. LLMS United States

M-Tech International, Inc. United States

CAT2 LIMS

MAQSIMA GmbH MAQSIMA LAB+ Germany

Mechatronics BV L@SSIST Netherlands

Megaware, Inc. LIAS United States

Metallurgical Systems Pty. Ltd. MS-LIMS Australia

Micronic Europe BV Track-IT Netherlands

Mindfire Solutions Pvt. Ltd. custom India Develops custom software solutions,
including LIMS

MIPS NV GLIMS Belgium

Modul-Bio SAS MBioLIMS France

Mongoose Coding Mongoose LIMS United States

Mountain States Consulting, LLC MSC-LIMS United States

LIMS vendor 196

Moxie Informatics, LLC Moxie United States

Mukon CC Skylims South Africa

Myfab Myfab LIMS Sweden

National Agribusiness Technology Center USALIMS United States

National Cancer Institute caLIMS United States

Nippon Control System Corporation SimpLabo Japan

Novatek International NOVA-LIMS Canada

Oasis Infotech Pvt. Ltd. EnviroLIMS EWM, LIMZ-RD, India

OasisLIMS, True-LIMZ CTL

Object Solutions Software AG OS-LIMS Switzerland

Ocimum Biosolutions Ltd. Biotracker LIMS India

Odysis SA myLIMS Switzerland Not to be confused with Labsoft

Tecnologia Limitada's myLIMS
product.

Online LIMS Canada Limited OnRepo Canada

OnQ Software Pty. Ltd. QLIMS Australia

Open-source software solution Bika LIMS N/A See Bika Lab Systems (Pty) Ltd. for
more info.

Open-source software solution caLIMS N/A See National Cancer Institute for
more info.

Open-source software solution OpenSpecimen N/A More information found on the

Krishagni Solutions Pvt. Ltd. page.

Open-source software solution GNomEx N/A More information found on

[2]
SourceForge.net .

Open-source software solution GNU LIMS N/A More information found on the
[3]
project page .

Open-source software solution LAMA N/A More information found on the

[4]
project website .

Open-source software solution Open-LIMS N/A More information found on the

[5]
project website .

Open-source software solution openBIS N/A More information found on the

[6]
project website .

Open-source software solution OpenELIS N/A More information found on the

[7]
project website .

Open-source software solution Screensaver HTS LIMS N/A More information found on
[8]
SourceForge.net .

Open-source software solution SMITH N/A More information found on Bitbucket

[9]
.

Open.Co Srl ProLab.Q Chemical & Manufacturing, Italy

ProLab.Q Food & Beverage,
ProLab.Q LIMS, ProLab.Q Wine

Oracle Corporation Oracle Health Sciences Clinical United States

Development Analytics
LIMS vendor 197

Orsyx eL@b Israel

Oy Fision Ltd. Broadsight LIMS Finland

PANalytical BV SPARCS Netherlands

Pardus d.o.o. eQMS::LIMS Croatia

Pathology Data Systems Ltd. Ascentos Switzerland Former products were PathData,
ReproData, and ToxData.

PD Evidence, LLC PDEvidence LIMS United States

pdv-software GmbH pdv-lims 3 Germany

PerkinElmer Inc. LABWORKS United States

Persistent Systems Ltd. ChemLMS United States Acquired from Agilent.

Pharma Soft Sol Pvt. Ltd. Pharma Soft Sol LIMS India

Phylum SARL Phylum.Laboratoire France

PiControl Solutions, LLC PiLims United States

Polisystem Informatica Srl Analisi Italy

Porter Lee Corporation Crime Fighter BEAST United States

Prevas AB Mikon LIMS Sweden

ProBioData GmbH BioProcessDB Germany

Process Solutions Canada Limited LDMS Canada

Prog4biz Software Solutions Ltd. BookitLab Canada

Progeny Software, LLC Progeny LIMS United States

Progile Infotech Pvt. Ltd. Pro-LabManager India

Promadis Pty. Ltd. Caseman Australia

Promium, LLC Element LIMS United States

Qualitype GmbH Abetter LIMS Germany

QBCon (Pty) Ltd. Lab-i South Africa

QUALIMS SARL QUALIMS France

Quality Institute of America, Inc. QISS-LIMS United States

Quality Systems International Corporation VersaLIMS.NET, WinLIMS.NET United States

Quartz Imaging Corporation Quartz FA-LIMS Canada

Raddec International Ltd. Raddec-LIMS United Kingdom

raytest Isotopenmessgeraete GmbH Raphaela RS Germany

Rescop BV RC-LIMS The Netherlands

Reston Stable Isotope Laboratory LIMS for Lasers, LIMS for Light United States The RSIL is part of the U.S.
Stable Isotopes Geological Survey.

RJ Lee Solutions, LLC THEMIS United States

RDS Nordest Srl CQT2000 LIMS Italy

Ross Group Inc. UVIS United States

LIMS vendor 198

RURO Inc. ezColony, FreezerPro, United States

LIMS 24/7

SampleNavigator BV SampleNavigator Netherlands

Sapio Sciences, LLC Exemplar Biomarker Discovery, United States

Exemplar Dx LIMS,
Exemplar Research LIMS

ScienTek Software, Inc. iStability LIMS United States LIMS designed for pharmaceutical
stability testing programs
and stability test management

Shimadzu Corporation LIMSsolution Japan

Sibio SAS custom LIMS France Previous products were called

SibioCLE and TraceLite.

Siemens AG SIMATIC IT Unilab Germany

Smallcapcrm IT Solutions Pvt. Ltd. SCC LIMS India

Sofcom (Private) Limited Spectrum Pakistan

SoftTrace Ltd. SoftTrace LIMS Ireland

Software for Life Sciences BV LabScores Netherlands

Software Point Oy LabVantage BioBanking, LabVantage Finland Acquired by LABVANTAGE in

LIMS, April 2011. C5 LIMS was renamed to
LABVANTAGE Medical Suite, "LABVANTAGE Medical Suite" in
TasteBOSS December 2012.
WilabLIMS/LimsBOSS

Softwaresysteme Keeve GmbH RHAPSODY LIMS Germany

Spectra QEST Australia Pty. Ltd. QESTField, QESTLab Australia

STaCS DNA Inc. STaCS Canada

Stanford University School of Medicine MendeLIMS United States

STARLIMS Corporation STARLIMS United States Bought by Abbott in 2010.

Stone Bond Technologies, LP EE-LIMS, MicroLIMS United States

Summit Research Services Metabase United States

Sylab Mditerrane CALYPSO LIMS France

System Approach, Ltd. Lab Keeper Russia

TechWare Incorporated Logbook Discovery, TechWare United States

MainTrac

The Edge Software Consultancy Ltd. BioRails LIMS United Kingdom

Thermo Scientific Darwin, Galileo, Nautilus, United States Note: a division of Thermo Fisher
SampleManager, Watson Scientific, Inc.
LIMS vendor 199

Timeless Medical Systems Timeless LIMS Canada

Tribal Software, Inc. LIMS Lyte, Tribal-LIMS United States

Triestram & Partner GmbH lisa.lims Germany

Trilogy Group Limited HAND, STAR, TAPS, TIME United Kingdom

Two Fold Software Limited Qualoupe LIMS United Kingdom

U.S. EPA FORMS II Lite United States

UNIConnect LC UNIFlow United States

Valdata Systems USA, Inc. Valdata LIMS United States

Vela Software International, Inc. Datamine LIMS Canada

Vette EDV-Beratung & Entwicklung GmbH TransGraph Germany Quality management software with a
LIMS module

Waters Corporation NuGenesis 8 United States NuGenesis 8 is a data management

and workflow package
of applications, including NuGenesis
Sample Management.

Wavefront Software, Inc. Wavefront LIMS United States

WESTcom Logiciels et Services SARL ARES, EDIlab, LimsOnLine France

White Point Systems, Inc. NAPIS United States

Wixon and Cross, LLC LIMFree and LIMFinite United States

Yokogawa Electric Corporation Lab-Aid Japan

Yullin Technologies Co., Ltd. LabMate Enterprise South Korea

Inactive LIMS vendors

Vendor Key LIMS offering(s) Headquarters Additional notes
(Country)

4S Information Systems Ltd. DAWN LIMS United States While 4S still actively develops clinical software,
it no longer develops/distributes DAWN LIMS.

Accelrys, Inc. Accelrys LIMS N/A Accelrys was acquired by Dassault Systmes SA on April 29,
2014.

Agencourt Bioscience Corp. Galaxy LIMS N/A Bought by Beckman Coulter, Inc. in 2005.

ALTIK SAS SOLUTION Laboratoire N/A Bought by Limseo SARL in September 2013.

Amersham Biosciences Corp. Scierra LWS N/A Bought by General Electric.

APAC GmbH APA-LIMS Germany Company is still active but seems to no longer offer APA-LIMS.

Applied Biosystems, Inc. SQL*LIMS N/A Merged with Invitrogen Corporation in November 2008
to form Life Technologies Corporation.
LABVANTAGE Solutions, Inc. purchased
SQL*LIMS from Life Technologies in 2009.

bizzApps Quality Manager N/A On August 16, 2013, OpenText Corporation acquired Cordys
Holdings BV,
and by extension bizzApps BV.
LIMS vendor 200

Bridge-Soft, LLC QMS, VDP N/A Per owner, LIMS no longer offered and business will be closed
by end of 2014.

CambridgeSoft Corporation Workflow LIMS N/A Bought by PerkinElmer Inc. in March 2011.

CARDIAC AS IMATIS LIMS N/A Split into two entities: Baze Technology AS
and IMATIS AS

ChikPea, Inc. ChikPea LIMS United States Company still active, but discontinued LIMS sometime after
February 2015.

Clondiag Chip Technologies PARTISAN arrayLIMS N/A Rebranded to Alere Technologies GmbH
GmbH in 2010, apparently ending PARTISAN.

Creon Lab Control AG Q-DIS/QM N/A Bought by Waters Corporation. LIMS phased out?

Datasign AG KinLIMS N/A Bought by Unilog S.A. in 2001.

EKM Corporation LABTrack N/A Former reseller of LABTrack, LLC's LABTrack software.

GraphLogic, Inc. Sequencing LIMS, Service N/A The company dissolved November 21, 2011.
Center LIMS

Green Mountain Logic, Inc. LabPas N/A Bought by Phase Forward Incorporated in 2007. LabPas
also carried on to Phase Forward.

Hollison Technologies CIMS United States Company still active but no longer appears to offer CIMS.

Honeywell Process Solutions Honeywell LIMS United States Honeywell is still an active vendor; however, they
discontinued their LIMS in 2014.

i-punkt Software GmbH LABORA N/A Bought by MAQSIMA GmbH in 2001.

IMR Technologies LLC MATware N/A Originally a division of IMR Test Labs,
both IMR Tech and MATware appear defunct.[citation needed]

INLOG SA ANALYS, EDGELab N/A On 31 August 2014, INLOG ceased functioning as "a
Haemonetics Company"
and was fully absorbed into Haemonetics Corporation.

InnaPhase Corporation Galileo, Newton, N/A Acquired by Thermo Scientific in 2004, with Thermo
Thompson, Watson continuing development on some products.

Instem Computer Systems Ltd. DATATOX-F1 N/A Sold and changed name to Instem, Ltd. in 2000.
Name changed again to Capula, Ltd. in 2002.
LIMS assumably discontinued.

Kenny Agrisoft Ltd. DairyLIMS Ireland Company still active but discontinued its DairyLIMS laboratory
information management system
(LIMS) sometime in 2015.

LabHQ Ltd. LabHQ N/A LabHQ LIMS was transferred to SkySource Ltd, and LabHQ
Ltd.
officially dissolved on March 5, 2013.

LabIT Solutions AB LabMaster N/A Bought by Software Point Oy in 2010.

LabMaster now a Software Point product.

LabSys Ltd. LabSys LIMS N/A LabSys Ltd. officially dissolved on May 22, 2010.

LabTech, Inc. Kuiper-LIMS United States Company still active but Kuiper-LIMS was discontinued
sometime in 2015.

Lemm Tech Enterprises, Inc. Labvironment United States The company is operational but it no longer offers
Labvironment.

Management Systems FLIMS N/A Bought by Lockheed Martin in 2007.

Designers, Inc.

MBIS, Inc. b.a.r.d. LIMS Algeria Formerly a product of Forensic Technology, Inc.
LIMS vendor 201

Mikon AS Mikon LIMS N/A Bought by Prevas AB in 2007.

Mincom Pty. Ltd. Mincom CCLAS N/A Acquired by ABB Group on May 9, 2011 and fully integrated
into subsidiary Ventyx, Inc. on February 6, 2012.

Nuvotec, Inc. OmniLIMS N/A Merged with Pacific EcoSolutions, Inc. to form Nuvotec USA,
Inc. Later became Columbia Energy & Environmental Services,
Inc.

Open-source software solution FreeLIMS N/A See the entry on LIMS at work GmbH for more info.

Orga Lab GmbH CSI-LIMS Germany The company is operational but it no longer offers CSI-LIMS.

Phase Forward Incorporated LabPas LIMS, Waban LIMS N/A Acquired by Oracle Corporation in August 2010.
See article for full history.

ReTiSoft Inc. Datapilot Canada Company still active, but Datapilot seems to have been phased
out as of 2013.

Sarla Technologies Pvt. Ltd. PLIMS India While still active, the company phased out PLIMS in late 2014.

Sciformatix Corporation SciLIMS United States Website went dead in 2015, and company owner changed jobs.
Presumed dissolved.

SkySource Ltd. LabHQ United Changed name to Broughton Software Ltd.

Kingdom

Telecation Aspen LIMS, Conifer LIMS N/A Telecation bought by OPS Systems in 2004.
OPS Systems bought by Hach Company in 2009.
Zumatrix, Inc. apparently supporting Aspen LIMS.

Tellac Applications TELLAC'Suite N/A Bought by APILOG Automation group in 2001.

Marketed as QUALIMS.

Tieto Corporation Seamless LIMS Finland Company still active, but product discontinued in roughly late
2013.

Tropical Software Solutions, LabPartner N/A Per Florida Department of State, business inactive.
Inc.

TUSC Computer Systems METRIX N/A Changed name to TUSC IT Scripts.

Sold METRIX to LabWare, Inc.

Ventyx, Inc. CCLAS United States Mincom Pty. Ltd. absorbed into Ventyx along with CCLAS on
February 6, 2012.
Ventyx became ABB Enterprise Software on January 30, 2015.

Visual Access Health Systems VATIM N/A Web presence ended sometime in 2013
Pvt. Ltd. or 2014. Status not clear.

Waban Software, Inc. Waban LIMS N/A Bought by Phase Forward Incorporated in 2009.
Waban LIMS now controlled by Phase Forward.

Wildtype Informatics LLC Wildtype Linx N/A Dissolved (see vendor article for details)

YourLabData.com Your Lab Data N/A The website ceased to operate sometime after February 9, 2014.

Zumatrix, Inc. Matrix Gemini N/A Used to distribute and support Autoscribe Ltd.'s product.
Now absorbed into subsidiary Autoscribe Informatics Inc.
LIMS vendor 202

LIMS vendors with unknown status

Vendor Key LIMS offering(s) Headquarters Additional notes
(Country)

Afrosoft International South Africa VeriLIMS South Africa Web site defunct.
(Pty) Limited

Computerised Laboratory VeriLIMS South Africa Web site defunct. Can't verify if
Applications (Pty) Ltd Afrosoft International South Africa (Pty) Limited
and their VeriLIMS product are related.

Dataplex Technologies, Inc. Key Solutions United States Last update seems to be from 2005. In May 2012 website is blank
page.

Finna Technologies LabAnalyst.NET United States

First Align FirstAlign Laboratory Unknown Is/was a division of Biber, Inc. FirstAlign.com dead.
BiberTech.com dead. BiberInc.com mostly dead.

INAS Datentechnik GmbH QBase 5.0 Germany Site under construction. LIMS/company may be defunct.

Ingensis Limited TLIMS Unknown Website http:/ / www. ingensis. co. uk/ not updated since 11
December 2009.

LabPlus Technologies, Inc. LabPlus, LimsLink United States Website is defunct though business license still active. Status
unknown.

Latent Logics Infosoft Pvt. Ltd. Lab Pro 2004 India Website was suspended by host in late 2013 or early 2014. Status
unknown.

LeanRP Q-Cent India According to domain host, "domain name expired on 8/29/2014 and
is pending renewal or deletion."

MedToxSoft, LLC MedTox LIMS United States Website is incomplete and hasn't been updated since 2011.

MurriWare SAS SILAB Unknown

Open-source software solution BonsaiLIMS N/A [10]

More information found on SourceForge.net .

Open-source software solution SIGLa N/A [11]

More information found on the project website .

Qualtrace International Ltd. QualTrace LIMS Unknown

SAME Sistemas Informticos SA CALIBRA2002, Spain Website doesn't function; status unknown.
LIMS2000i

Siri Technologies Pvt. Ltd. SIRI LIMS India Website doesn't function; status unknown.

Sullivan Software LABTROL Unknown

SWAG SL QA-Lab, QA-Traza, Spain Website doesn't function; status unknown.

W-Instrum, WQC

Xenco Software EnviroLIMS United States Now known as Xenco Laboratories.

Not clear what name of LIMS is now.
LIMS vendor 203

References
[1] http:/ / sourceforge. net/ projects/ bika/
[2] http:/ / sourceforge. net/ projects/ gnomex/
[3] http:/ / savannah. gnu. org/ projects/ lims/
[4] https:/ / launchpad. net/ mousedb
[5] http:/ / www. open-lims. org/ home. html
[6] http:/ / www. cisd. ethz. ch/ software/ openBIS
[7] http:/ / openelis. org/
[8] http:/ / sourceforge. net/ projects/ screensaver/
[9] https:/ / bitbucket. org/ yuriy_vaskin/ smith/ overview
[10] http:/ / sourceforge. net/ projects/ bonsailims/
[11] http:/ / luar. dcc. ufmg. br/ sigla/

LIS vendor
Looking for non-clinical, more sample-based informatics systems? You may want to also check out the LIMS vendor page.

Before adding a specific vendor or product to LIMSwiki, please review the LIMSWiki:Vendor page and LIMSWiki:Product page articles
respectively.
They explain the general guidelines that should be followed when creating such pages.

A LIS vendor is an entity (business, company, corporation, etc.) which provides laboratory information system
(LIS) software or software packages. The LIS software may be very generalized to handle a great number of clinical
situations, or it may be very specific to handle the needs of a specific clinical setting.
Given the way some vendors choose to market their product, and also considering the continued blurring of
differences between a LIS and a laboratory information management system (LIMS), some products may have
obvious LIS functionality yet are marketed as a LIMS. For the purposes of presenting a thorough list of options,
vendors that offer a software product obviously tailored to clinical and healthcare-related labs despite being
marketed as a LIMS will also be considered a LIS vendor.
Finally, a LIS may also appear as a fully-featured module within a hospital information system (HIS), for example.

Active LIS vendors

Note: The columns of this table are sortable for your convenience. Simply click the small arrows in the
title of each column to use this feature. Additionally, if you wish to sort by column X and then column
Y, simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and
left-click the desired arrow for the second column to sort by.
LIS vendor 204

Vendor Key LIS offering(s) Headquarters Additional notes

(Country)

A&T Corporation CLINILAN Japan

Advanced Business Software PHIMS United States

Aeon Innovative Solutions, Inc. PAN LIMS United States

Agfa HealthCare NV Bioserveur, Hexalis Belgium Hexalis and Bioserveur are today only deployed in the
French market.

Akhil Systems Pvt. Ltd. Miracle LIS India

Alfa Wassermann, Inc. Alfa LIS United States

Allengers Infotech Pvt. Ltd. Allengers LIS India

Alphasoft GmbH Unilab-700 Germany

American Soft Solutions Corp. PROLIS United States

AP-Visions, LLC xLab United States

Apex HealthWare, LLC Apex LIS United States

Aspyra, LLC ASPYRA LIS United States

Attune Technologies Pte. Ltd. Attune LabKernel Singapore

BARTELT GmbH datalabX Austria

Bio-Analytical Technologies Pvt. PathlabSys India

Ltd.

BioFortis, Inc. Labmatrix United States

Birlamedisoft Pvt. Ltd. Maxim LIS India

Bodgro Technische Automatisering LabTrain Netherlands

CV

BtB Software, LLC BtB Software United States

Busysoft Systems Pvt. Ltd. LabMate India

Cegeka NV CorLabs Belgium

Cerebrum Corporation LABdivus Clinical United States

Cerner Corporation Millennium PathNet, United States

PowerChart

Cirdan Imaging Ltd. ULTRA Northern Ireland

Clarisys Informatique SARL Clarilab, MCA, OneLink France

Clin1, LLC Clin1 Suite United States Company was formerly named Clinical Software
Solutions.

Clinical Systems Ltd. ClinAxys II United Kingdom

CliniComp International, Inc. EHR United States An electronic health record with a LIS module

ClinLab, Inc. ClinLab LIS United States

Comp Pro Med, Inc. Polytech Laboratory United States

Information System

CompuGroup Medical AG CGM Analytix, CGM Germany

Enterprise LIS, LabDAQ

CompuMedical Health Care Rx-Care LIS Egypt

Solutions SAE Co.
LIS vendor 205

Computer Service and Support, Inc. CSS LIS United States

Computer Technology & Services CTServ LIS Lebanon

SARL

Comtron Corp. Labgen LIS United States

Custom Software Ltd. NetAcquire LIS Ireland

DataSel Bilgi Sistemleri A.. AviCenna Turkey A HIS with a LIS module

Desarrollo Aplicaciones Sanitarias SilverLab Spain

SL

DL Sant SAS Odancio France

Diamond Computing Company LabGEM United States

DOMA Technologies, LLC DOMA LIS United States

Dorner GmbH & Co. KG X/Lab Germany

dWise Healthcare IT Solutions Pvt. Lifetrenz LIS India

Ltd.

Dynamtek Corporation Labsis United States

Emergency Care Dictation Services, Empower HIS United States A HIS with a LIS module
Inc.

Entre Technology Group GenesysNSL United States

Exleaz Solutions Limited MediEaz LIS United Kingdom

Fonet Bilgi Teknolojileri A.. FONET LIS Turkey

Glivytech Services Pvt. Ltd. AcutCare LIS India

Haemonetics Corporation EdgeLab, Sapanet United States

Hemasoft Software SL e-Delphyn LIS Spain

Hex 'ff' Inc. LAB/HEX LIS United States

HISTONE Informatique SARL LAM400 France

IN2 Ltd. BioNET LIS Hungary

Infomed C.S. sLis Greece

Information Management Services, BSI, SEER*DMS, United States

Inc. SEER*STAT, SQUISH

Innovasystem LLC LIS Innovasystem Russia

Inovapar Solues Ltda. Motion LIS Brazil

Instem LSS Limited Centrus, Provantis United Kingdom

Integrated Business Solutions LABLION United States

Group, LLC

Integrated Software Solutions Pty. OMNI-Lab Australia

Ltd.

InterSystems Corporation TrakCare United States

IT Easy Software Solutions WebLIS Professional Phillipines

iTack Solutions i-Labs United States

ITDOSE Infosystems Pvt. Ltd. Innopath India

J&S Medical Associates, Inc. LabTrak United States

Kameda Infologics Pvt. Ltd. YASASII Japan A HIS with a LIS module
LIS vendor 206

Laboratory System Technologies Disa*Lab South Africa

(Pty) Ltd.

LabSoft, Inc. Beethoven II, EZLink, United States

LabNet

Labthroughput LTP Achiever United States

LabWare, Inc. LabWare LIMS United States LIMS software with additional LIS-like functionality

LigoLab, LLC LigoLab LIS United States

LRS Health Pty. Ltd. MediPATH, MediPATH AP Australia

Margy Tech Pvt. Ltd. iLIS India

McKesson Corporation McKesson Lab United States

Medasys SA DxCare, DXLAB, DxLabOne France

MEDCOM Information Systems, MEDCOM Lab Manager United States

Inc.

MEDHOST, Inc. MEDHOST LIS United States

Merge Healthcare Inc. Merge LIS United States

MIMSYS Technologies Pvt. Ltd. MIMSYS LIMS ERP India LIS is a module for the commercially offered Sage 300
ERP software by Sage Software, Inc.

MIPS NV GLIMS Belgium LIS software marketed as a LIMS

Moonchase Lab Online Belgium

Mukon CC PathWay South Africa

Multidata Computer Systems, Inc. MultiTech United States

Netika SARL KaliLab, KaliSil France

NeTLIMS NJ, LLC AutoLims United States

Neusoft Medical Systems Co., Ltd. Neusoft LIS China

NoemaLife SpA DNLab Italy

Northern Software, Inc. eLab.Sys United States

Nortec Software, Inc. Nortec LIS United States

NovoPath, Inc. NovoPath United States

NTT DATA Corporation Optimum Clinicals Japan, United

States

OGER SYSTEMS Oger Medical Information Saudi Arabia

System

Open-source software solution C4G BLIS N/A [1]

More information found on the project website .

Open-source software solution OpenSpecimen N/A More information found on the Krishagni Solutions
Pvt. Ltd. page.

Open-source software solution OpenELIS N/A [2]

More information found on the project website .

Orchard Software Corporation Orchard Harvest United States

Pact Sotraig SARL ADLAB-400 France

Pathagility, LLC Pathagility United States

PCS Technology Limited Lab Plus India

pdv-software GmbH PDV-LIS II Germany

LIS vendor 207

Philips Medical Systems BV LABOSYS, MICROS Netherlands

Physicians Independent PathX United States

Management Services, Inc.

Pixeon Comrcio e X Clinic Nexus Brazil

Desenvolvimento de Software Ltda.

Point of Care Solutions Pty. Ltd. v-LAB Australia

Prestij Yazlm ve Bilgi Sistemleri Winsoft LIS Turkey

PROTEK Dental Medikal Sanayi ve i-LIS Turkey

Ticaret Ltd. Sti.

Psyche Systems Corporation WindoPath United States

QuadraMed Affinity Corporation QCPR United States An EHR with a LIS module

Quality Software Systems, Inc. LabHealth United States

Remedium Health Technologies Pvt. Remidium HIMS India A hospital information system with a LIS module
Ltd.

Roche Diagnostics Limited cobas infinity IT solutions Switzerland Product may not be available in the U.S.

Schuyler House SchuyLab United States

Seacoast Laboratory Data Systems, SurroundLab United States

Inc.

Shreay Technology Solutions Locus India

Siemens AG Servolab, TD-Synergy Germany Unclear what happened to former product NOVIUS
Lab.

SLCLAB Informtica SL ALFA21 Spain More information found on www.slclab.com.

Soft Computer Consultants, Inc. SoftLab United States

SofTov Medical Systems Ltd. AutoLab Israel Note: SofTov is NeTLIMS' regional distributor of
AutoLab in the Middle East.

Software Point Oy LABVANTAGE Medical Suite Finland LIS software marketed as a LIMS

Srishti Software Applications Pvt. PARAS LIS India

Ltd.

STAPRO s.r.o. FONS Openlims Czech Republic LIS software marketed as a LIMS

Sunquest Information Systems, Inc. ICE, Sunquest Laboratory United States

Suvarna Technosoft (P) Ltd. Suvarna-HIS India A HIS with a LIS module

Sysmex Corporation Delphic LIS, HCLAB Japan Products may only be available in specific markets.

Systelab Technologies SA Modulab Spain

Swisslab GmbH SWISSLAB Germany

Synbiotix Ltd. Synbiotix Hospital Information United Kingdom A HIS with a LIS module
System

Tainosystems Inc. Silabmed Canada

Technidata SAS TD-Synergy France

Tendercare Infotech India Pvt. Ltd. Capsule LIS India

Terra Systems O MiniLIS, TerraLab Estonia LIS software TerraLab marketed as a LIMS

Timeless Medical Systems Timeless LIMS Canada LIS software marketed as a LIMS

Universal Software Solutions, Inc. VersaSuite LIS United States

LIS vendor 208

Vasa Technologies Ltd. Pathosys India

vision4health Laufenberg & Co. molis Switzerland molis originally owned by Sysmex Corporation.
CompuGroup Medical AG
acquired vision4health in January 2014.

VitalAxis, Inc. VitalPath United States LIS software marketed as a LIMS

Wipro Limited Wipro HIS India A hospital information system with a LIS module

XIFIN, Inc. XIFIN LIS Anywhere United States

Xybion Corporation Pristima Suite United States

Inactive LIS vendors

Vendor Key LIS offering(s) Headquarters Additional notes
(Country)

ACT Medisys, Ltd. INTEGO N/A Bought by iSoft.

Antek HealthWare, LLC LabDAQ United States Merged into CompuGroup Medical, Inc. December 31, 2011.
See Antek record for more info.

Antrim Corporation Answers Medical Information N/A/ After being bought by Sunquest Information Systems, Inc. in
Systems 1996,
Sunquest was bought by Misys plc in 2001.

Benetech, Inc. G*LIS Canada Company still active, but stopped marketing G*LIS sometime
after May 1, 2013.

BCS Limited Masterlab N/A/ After being bought by Torex PLC in 2002,
Torex was bought by Clinisys Solutions Limited in 2005.

Biomar Technologies, Inc. LAB Wizard N/A Went bankrupt.

Cambridge Biotech Software, POLARIS N/A Company officially dissolved August 15, 2008.
Inc.

CDS Group, Ltd. TelePath, DDMS N/A Bought by ACT Medisys, Ltd.

Dedalus SpA Dedalus LIS Italy Company still active but no longer offers LIS.

Eclipsys Corporation Sunrise Laboratory N/A See Allscripts. Eclispsys merged with Allscripts in 2010.

Elekta AB IntelliLab Sweden The company discontinued marketing IntelliLab LIS on its
website sometime
between May and July 2013.

Health Science Systems
OPUS N/A Bought OPUS Healthcare Solutions, Inc and assumed its
name[citation needed].
OPUS Healthcare bought by Quality Systems, Inc. in 2010 and
merged with
NextGen Healthcare Information Systems, Inc.

Healthcare Management HMS Laboratory N/A Became MEDHOST, Inc. on Dec. 16, 2013.
Systems, Inc.

IMPAC Medical Systems, Inc. IntelliLab N/A Bought by Elekta AB in 2005.

INLOG SA EDGElab, SAPANET N/A On 31 August 2014, INLOG ceased functioning as "a
Haemonetics Company"
and was fully absorbed into Haemonetics Corporation.

IntelliData, Inc. IntelliLab N/A Bought by IMPAC Medical Systems, Inc. in 2002.

ISYS/Biovation Messenger N/A Website shut down in mid-2014. Status assumed dissolved.
LIS vendor 209

Keane, Inc. Keane Optimum United States Purchased by and absorbed into NTT DATA Corporation.

LAB-InterLink LAB-Manager N/A Bought Labotix Automation, Inc. in 2000; took that name in
2007.

Labotix Automation, Inc. RRUSH N/A Bought by Cerner Corporation March 18, 2013.

LCI, Inc. Hummingbird N/A Acquired by American HealthNet, Inc., which was then acquired
by
Healthland in 2009.

M/MGMT Systems, Inc. M/LAB N/A Bought by Common Cents Systems, Inc. in 2006.

NFLC, Inc. HYBRID N/A Company seems to be defunct. Only online evidence is a
canceled trademark for HYBRID in 2008.

Rabbit Healthcare Systems Rabbit EHR United States Website went down sometime in late 2014 or during 2015.
Presumed closed.

SGS Cortex Quality Software LAB/400 N/A Was bought by Cegeka in 2005.

Sysware Healthcare Systems, SYSWARE LIS N/A Bought by Eclipsys Corporation in 2006.
Inc.

Tieto Corporation FlexLab/Kemi, Finland Company still active, but product discontinued in roughly late
FlexLab/SymPathy 2013.

TriFour Healthcare Ltd. TriLab South Africa The company is still active but in middle to late September 2013
the company stopped
marketing its LIS TriLab on its website.

Triple G Corporation ULTRA LIS N/A Bought by GE Medical Systems Information Technologies in
2003.

Visual Access Health Systems VATIM SOLUTIONS N/A Web presence ended sometime in 2013
Pvt. Ltd. or 2014. Status not clear.

William Woodard Associates Winpath 98 N/A Changed name to Sysmed Solutions Limited in 2003,
and then CliniSys Solutions Limited in 2004.

LIS vendors with unknown status

Vendor Key LIS offering(s) Headquarters Additional notes
(Country)

Beijing ZhiFang S&T Development DigitLab China

CCIF SARL Winlabo SGL France Both websites went dark in October 2015. Status unknown.

Great Mind Solutions LabReader India On September 26, 2013, the LabReader.com domain
expired.
It remains unclear if the company is dead or not..

Quartesect Pvt. Ltd. Cliemat Unknown

True-Medix Diagnostics, Inc PROLIS Unknown

LIS vendor 210

References
[1] http:/ / blis. cc. gatech. edu/ index. php
[2] https:/ / sites. google. com/ site/ openelisglobal/

ELN vendor
Before adding a specific vendor or product to LIMSwiki, please review the LIMSWiki:Vendor page and LIMSWiki:Product page articles
respectively.
They explain the general guidelines that should be followed when creating such pages.

An ELN vendor is an entity (business, company, corporation, etc.) which provides electronic laboratory notebook
(ELN) software or software packages. The ELN software may be very generalized to handle a great number of
laboratory situations, or it may be very specific to handle the needs of a certain field of study.

Active ELN vendors

Note: The columns of this table are sortable for your convenience. Simply click the small arrows in the
title of each column to use this feature. Additionally, if you wish to sort by column X and then column
Y, simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and
left-click the desired arrow for the second column to sort by.

Vendor Key ELN offering(s) Headquarters Additional notes

(Country)

AAC Infotray AG Limsophy DoDoc Switzerland

Advanced Chemistry Development, Inc. Electronic Notebook for Canada

Academia

Agaram Technologies Pvt. Ltd. LogiLab ELN India

AgiLab SAS ELN BioLab, ChemLab, and France

FormuLab

AgileBio LabCollector United States

Agilent Technologies, Inc. OpenLAB ELN United States

Amphora Research Systems, Inc. CompliantPad, OpenELN, United States

PatentPad, PatentSafe

Arxspan, LLC ArxLab Electronic Notebook United States

Asseco Danmark A/S shareSignELN Denmark

ATGC Labs, LLC ActiveLN United States

Bio-ITech BV eLabJournal ELN The

Netherlands

BiochemLab Solutions Electronic Lab Notebook United States

BioSistemika LLC GENEIO Slovenia

ChemBytes Espresso ELN Switzerland

ChemInnovation Software, Inc. CBIS United States

CompuDrug International, Inc. Laboratory Manager Plus United States

Core Informatics, LLC Core ELN United States

ELN vendor 211

Dassault Systmes SA Accelrys ELN France Dassault acquired Accelrys, Inc. on April 29,
2014.

DeltaSoft, Inc. ChemCart ELN United States

DIMA Engineering Pvt. Ltd. eLabNotes India

Dotmatics Limited Studies Notebook, One-Click United

Chemistry ELN Kingdom

Easylab Ltd. Easylab Turkey

eNovalys SAS LabBook France

enso Software GmbH ensochemLab Germany

Evolvus Pvt. Ltd. Electronic Lab Notebook India

EZQuant Ltd. EZQuant-ELN Israel

FORMULATOR Software, LLC FORMULATOR United States

Genohm BVBA SLims Belgium

HiTec Zang GmbH eJournal Germany

iAdvantage Software, Inc. eStudy United States

ID Business Solutions Ltd. BioBook, ChemBook, United

E-WorkBook Kingdom

Instem LSS Limited Logbook United

Kingdom

Kalliste Systems, Inc. Kalliste eSystems United States

KineMatik Ltd. eNovator United States

Labage SA benchsys-lab Belgium

Lab-Ally LLC CERF, RSpace United States

LabArchives, LLC LabArchives United States

labfolder GmbH labfolder Germany

Labii, LLC Labii ELN United States Software still in beta development as of
November 2015

LABTrack, LLC LABTrack United States EKM Corporation was previously a distributor
of LABTrack.

LABVANTAGE Solutions, Inc. eNotebook United States

LabWare, Inc. LabWare ELN United States

Laurus Infosystems Pvt. Ltd. Chemia India

Mestrelab Research S.L. MBook Spain

National Institute of Allergy and Infectious LabShare United States

Diseases

NoteBookMaker, LLC NoteBookMaker United States

Online LIMS Canada Limited Online Worksheet Canada

Open source software solution CyNote N/A More information found on SourceForge.net
[1]
.

Open source software solution eLabFTW N/A [2]

More information found on the project site .

Open source software solution eln N/A [3]

More information found on the project site .
ELN vendor 212

Open source software solution Indigo ELN N/A [4]

More information found on the project site .

Open source software solution LabTrove N/A [5]

More information found on SourceForge.net
[6]
and the project site .

Open source software solution open enventory N/A More information found on SourceForge.net
[7]
.

Open source software solution openBIS N/A Not a stand-alone ELN, but has an ELN plug-in.
[6] [8]
More info here and here .

Open.Co Srl Open.Co ELN Italy

PerkinElmer Inc. E-Notebook United States

Prog4biz Software Solutions Ltd. BookitLab Canada

quattro research GmbH quattro/LJ Germany

Research Innovations Limited eCAT, RSpace Scotland Lab-Ally LLC is the North American distributor
of RSpace.

Rescop BV RC-ELN The

Netherlands

RURO Inc. Sciency United States

SciCord, LLC SciCord United States

Sciformation Consulting GmbH Sciformation ELN Germany Based off the open-source open enventory ELN.

Scilligence Corporation Scilligence ELN United States

Shanghai Holo Sci-infor Co., Ltd. Electronic Lab Notebook China

shazino SAS hivebench France

Siemens AG SIMATIC IT R&D Germany

SPLhost, Inc. Datacloud United States

STARLIMS Corporation STARLIMS Electronic United States

Notebook

Studylog Systems, Inc. Study Director United States

SunBio IT Solutions Pvt. Ltd. SunBio ELN India

Sycomore Technologies SAS LeadAnalytics France

Synbiota Inc. Synbiota Canada Still in beta as of May 2014

Sysment Kft. Sysment Notebook Hungary

Systat Software Inc. SigmaCERF United

Kingdom
ELN vendor 213

TailorDev SAS arich.io France Software still in alpha development as of

November 2015

Terrington York Ltd. Labsform United

Kingdom

Textco BioSoftware, Inc. Gene Inspector United States

The Edge Software Consultancy Ltd. BioRails ELN United

Kingdom

Waters Corporation NuGenesis 8 United States NuGenesis 8 is a data management and

workflow package
of applications, including NuGenesis ELN.

Inactive ELN vendors

Vendor Key ELN offering(s) Headquarters Additional notes
(Country)

Accelrys, Inc. Accelrys ELN, Contur N/A Accelrys was acquired by Dassault Systmes SA on April 29, 2014.
ELN/iLabber

ArtusLabs, Inc. Ensemble ELN N/A Bought by PerkinElmer Inc.

CambridgeSoft E-Notebook N/A Bought by PerkinElmer Inc. in March 2011.

Corporation

Cognium Systems SA iPad ELN N/A Dissolved in the summer of 2014.

Contur Software AB Contur ELN/iLabber N/A Changed name of ELN from ConturELN to iLabber July 19, 2011.
Was acquired by Accelrys, Inc. in 2011.

Laboratory Data Solutions Labnotes N/A The company officially dissolved on September 10, 2013.
Ltd.

Labtronics Inc. Nexxis ELN N/A Bought by PerkinElmer Inc. in May 2011.

Neudesic, LLC Neudesic ELN United States While the company is still active, it seems Neudesic
no longer markets its ELN.

Open source software Electronic Laboratory N/A The project terminated in the winter of 2007.
solution Notebook

Open source software LabJ-ng N/A [9]

No project release since 2007: SourceForge.net
solution

Open source software tags4lab N/A [10]

No releases; last update 2009: SourceForge.net
solution

Open source software The Monster Journal N/A [11]

No update to project since 2009: SourceForge.net
solution

Rescentris, Inc. CERF United States Was absorbed into irisnote, Inc. then Lab-Ally LLC. See Rescentris
entry for more history.

SparkLix Bio IT Corp. SparkLix N/A The service was discontinued in the summer of 2014.

Symyx Technologies Inc. Symyx ELN N/A Merged with Accelrys, Inc. in 2010.
ELN vendor 214

VelQuest Corporation SmartLab gmpELN N/A Was bought by and absorbed into Accelrys, Inc. in January 2012,
with SmartLab becoming "Accelrys Lab Execution System",
a laboratory execution system.

ELN vendors with unknown status

Vendor Key ELN offering(s) Headquarters Additional notes
(Country)

Open source software solution MyLabBook N/A [12]

Still in pre-alpha on SourceForge: SourceForge.net

References
[1] http:/ / cynote. sourceforge. net/
[2] http:/ / www. elabftw. net/
[3] https:/ / launchpad. net/ eln
[4] http:/ / ggasoftware. com/ opensource/ indigo/ eln
[5] http:/ / sourceforge. net/ projects/ labtrove/
[6] http:/ / www. labtrove. org/
[7] http:/ / sourceforge. net/ projects/ enventory/
[8] https:/ / wiki-bsse. ethz. ch/ display/ openBISDoc/ openBIS+ for+ ELN
[9] http:/ / sourceforge. net/ projects/ labj/
[10] http:/ / sourceforge. net/ projects/ tags4lab/
[11] http:/ / sourceforge. net/ projects/ monsterjournal/
[12] http:/ / sourceforge. net/ projects/ mylabbook/

CDMS vendor
Before adding a specific vendor or product to LIMSwiki, please review the LIMSWiki:Vendor page and LIMSWiki:Product page articles
respectively.
They explain the general guidelines that should be followed when creating such pages.

An CDMS vendor is an entity (business, company, corporation, etc.) which provides chromatography data
management system (CDMS; or chromatography data system or CDS) software or software packages. The CDMS
software may be very generalized to handle a great number of laboratory situations dealing with chromatography, or
it may be very specific to handle the needs of a specific type of sample analysis.

Active CDMS vendors

Note: The columns of this table are sortable for your convenience. Simply click the small arrows in the
title of each column to use this feature. Additionally, if you wish to sort by column X and then column
Y, simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and
left-click the desired arrow for the second column to sort by.
CDMS vendor 215

Vendor Key CDMS offering(s) Headquarters Additional notes

(Country)

Advanced Chemistry Development, ACD/AutoChrom MDS, ACD/Chrom United States

Inc. Workbook,
ACD/ChromGenius

Agilent Technologies, Inc. EZChrom, Galaxie, United States

OpenLAB CDS

Beijing Teleh Electronic Tech Co., Bio-2000 China

Ltd.

Bruker Corporation HyStar United States

ChemSW, Inc. GPMAW, Mass Spec Tools United States

DataApex, spol. sro Clarity Czech Republic

Dionex Corporation Chromeleon United States Acquired by Thermo Scientific in May

2011.

E-Chrom Tech Co., Ltd. Chromatography Data System Taiwan

H&A Scientific, Inc. PC/Chrom United States

Jasco Europe Srl Chromnav Italy

Justice Laboratory Software, Inc. Chrom Perfect LSI, Chrom Perfect Spirit United States

LabLogic Systems Limited Laura 4 United

Kingdom

Open-source software solution OpenChrom N/A More information found on the project
[1]
website .

PerkinElmer Inc. Chromera United States

Promium, LLC Mint Miner United States

PSS Polymer Standards Service WinGPC UniChrom Germany

GmbH

Schlumberger Limited Malcom United States

Shimadzu Corporation LabSolutions Japan

Thermo Scientific Atlas CDS, ChromQuest, United States

EnviroLab Forms, QuanLab Forms

Waters Corporation Empower 3 United States

Yullin Technologies Co., Ltd. MultiChro South Korea

Inactive CDMS vendors

CDMS vendor 216

Vendor Key CDMS offering(s) Headquarters Additional notes

(Country)

Labtronics Inc. LimsLink CDS N/A Bought by PerkinElmer Inc. in May 2011.

Varian, Inc. Galaxie N/A Agilent Technologies, Inc. acquired Varian in May
2010,
integrating Varian's holdings fully.

References
[1] http:/ / www. openchrom. net/ main/ content/ index. php

SDMS vendor
Before adding a specific vendor or product to LIMSwiki, please review the LIMSWiki:Vendor page and LIMSWiki:Product page articles
respectively.
They explain the general guidelines that should be followed when creating such pages.

An SDMS vendor is an entity (business, company, corporation, etc.) which provides scientific data management
system (SDMS) software or software packages. The SDMS software may be very generalized to handle a great
number of laboratory situations, or it may be very specific to handle the needs of a certain field of study.

Active SDMS vendors

Note: The columns of this table are sortable for your convenience. Simply click the small arrows in the
title of each column to use this feature. Additionally, if you wish to sort by column X and then column
Y, simply left-click the desired arrow for the first column to sort by, and then hold the Shift key and
left-click the desired arrow for the second column to sort by.

Vendor Key SDMS offering(s) Headquarters Additional notes

(Country)

Agaram Technologies Pvt. Ltd. LogiLab SDMS India

Agilent Technologies, Inc. OpenLAB ECM United States

Core Informatics, LLC Core SDMS United States

Dexstr SA Inquiro France

Fink & Partner GmbH Dia Germany

Flywheel Exchange, LLC Flywheel United States As of November 2015 the software is still in beta testing.

Open-source software solution SciTran N/A [1]

More information found on the project page .

Poplar Solutions, LLC Labcore SDMS United States

STARLIMS Corporation STARLIMS United States

SDMS vendor 217

Thermo Scientific Data Manager United States

Waters Corporation NuGenesis 8 United States NuGenesis 8 is a data management and workflow
package
of applications, including NuGenesis SDMS.

Inactive SDMS vendors

Vendor Key CDMS offering(s) Headquarters Additional notes
(Country)

Labtronics Inc. Nexxis SDMS N/A Bought by PerkinElmer Inc. in May 2011.

SDMSSoft, LLC SDMS Software United States The website went offline in the fall of 2015. The company is presumably closed.

References
[1] https:/ / scitran. github. io/
Article Sources and Contributors 218

Article Sources and Contributors

LIMSwiki mission Source: http://limswiki.org/index.php?oldid=21693 Contributors: Shawndouglas

Information Source: http://limswiki.org/index.php?oldid=15163 Contributors: Shawndouglas

Informatics (academic field) Source: http://limswiki.org/index.php?oldid=21063 Contributors: Mikelong88888, Shawndouglas

Laboratory Source: http://limswiki.org/index.php?oldid=14988 Contributors: Andersjim, Shawndouglas

Laboratory informatics Source: http://limswiki.org/index.php?oldid=13729 Contributors: Andersjim, Jleecbd, LIMSinstitute, Mikelong88888, Shawndouglas, 2 anonymous edits

Bioinformatics Source: http://limswiki.org/index.php?oldid=14112 Contributors: Mikelong88888, Shawndouglas

Cancer informatics Source: http://limswiki.org/index.php?oldid=19541 Contributors: Shawndouglas

Chemical informatics Source: http://limswiki.org/index.php?oldid=15539 Contributors: Mikelong88888, Shawndouglas

Environmental informatics Source: http://limswiki.org/index.php?oldid=14682 Contributors: Mikelong88888, Shawndouglas

Evolutionary informatics Source: http://limswiki.org/index.php?oldid=19577 Contributors: Mikelong88888, Shawndouglas

Geoinformatics Source: http://limswiki.org/index.php?oldid=14678 Contributors: Mikelong88888, Shawndouglas

Health informatics Source: http://limswiki.org/index.php?oldid=21918 Contributors: Admin, Mikelong88888, Shawndouglas

Hydroinformatics Source: http://limswiki.org/index.php?oldid=14693 Contributors: Mikelong88888, Shawndouglas

Imaging informatics Source: http://limswiki.org/index.php?oldid=14719 Contributors: Mikelong88888, Shawndouglas

Public health informatics Source: http://limswiki.org/index.php?oldid=14746 Contributors: Shawndouglas

Laboratory information management system Source: http://limswiki.org/index.php?oldid=21878 Contributors: Andersjim, LIMSinstitute, Shawndouglas, 2 anonymous edits

LIMS feature Source: http://limswiki.org/index.php?oldid=12049 Contributors: Jleecbd, Shawndouglas

Laboratory information system Source: http://limswiki.org/index.php?oldid=15531 Contributors: Shawndouglas, 3 anonymous edits

LIS feature Source: http://limswiki.org/index.php?oldid=13941 Contributors: Shawndouglas

Chromatography data management system Source: http://limswiki.org/index.php?oldid=15245 Contributors: Shawndouglas, 3 anonymous edits

Electronic laboratory notebook Source: http://limswiki.org/index.php?oldid=15248 Contributors: LIMSinstitute, Shawndouglas, 2 anonymous edits

Laboratory execution system Source: http://limswiki.org/index.php?oldid=15252 Contributors: Sergio95810, Shawndouglas

Scientific data management system Source: http://limswiki.org/index.php?oldid=16228 Contributors: Andersjim, Shawndouglas

21 CFR Part 11 Source: http://limswiki.org/index.php?oldid=20352 Contributors: Andersjim, Jleecbd, Shawndouglas, 1 anonymous edits

40 CFR Part 3 Source: http://limswiki.org/index.php?oldid=20401 Contributors: Shawndouglas

ASTM E1578-13 Source: http://limswiki.org/index.php?oldid=21250 Contributors: Shawndouglas

Clinical Laboratory Improvement Amendments Source: http://limswiki.org/index.php?oldid=21625 Contributors: Avaughan, Shawndouglas

Good Automated Laboratory Practices Source: http://limswiki.org/index.php?oldid=7679 Contributors: Shawndouglas

Good Automated Manufacturing Practice Source: http://limswiki.org/index.php?oldid=21249 Contributors: Shawndouglas

Health Insurance Portability and Accountability Act Source: http://limswiki.org/index.php?oldid=21920 Contributors: Shawndouglas

Health Level 7 Source: http://limswiki.org/index.php?oldid=20739 Contributors: Shawndouglas

ISO 9000 Source: http://limswiki.org/index.php?oldid=20871 Contributors: Shawndouglas

ISO/IEC 17025 Source: http://limswiki.org/index.php?oldid=20870 Contributors: Shawndouglas

ISO/TS 16949 Source: http://limswiki.org/index.php?oldid=20873 Contributors: Shawndouglas

The American Society of Crime Laboratory Directors/Laboratory Accreditation Board Source: http://limswiki.org/index.php?oldid=21701 Contributors: Shawndouglas

The NELAC Institute Source: http://limswiki.org/index.php?oldid=20901 Contributors: Shawndouglas

Laboratory, Scientific, and Health Informatics Buyer's Guide Source: http://limswiki.org/index.php?oldid=23482 Contributors: Eusoft srl, Shawndouglas

Open-source laboratory informatics software Source: http://limswiki.org/index.php?oldid=23598 Contributors: Shawndouglas

Laboratory informatics consultants Source: http://limswiki.org/index.php?oldid=23468 Contributors: Shawndouglas

21 CFR Part 11: Audit guidelines and checklist Source: http://limswiki.org/index.php?oldid=15552 Contributors: Jleecbd, Shawndouglas

Health Insurance Portability and Accountability Act: Audit guidelines and checklist Source: http://limswiki.org/index.php?oldid=10947 Contributors: Jleecbd, Shawndouglas

Laboratory information management system (LIMS) questionnaire Source: http://limswiki.org/index.php?oldid=23594 Contributors: Shawndouglas

Laboratory information system (LIS) questionnaire Source: http://limswiki.org/index.php?oldid=23597 Contributors: Avaughan, Shawndouglas

Key laboratory informatics vendors and software Source: http://limswiki.org/index.php?oldid=22961 Contributors: Shawndouglas

LIMS vendor Source: http://limswiki.org/index.php?oldid=23158 Contributors: Admin, Andersjim, Asouza, Atgclabs, Eusoft srl, Furosa, Jrjoyce, Kklimswiki, Mbraspen, Michael, Orsyx,
Rjoseph, Shawndouglas, Slclab, Sowmya.MC, 3 anonymous edits

LIS vendor Source: http://limswiki.org/index.php?oldid=23181 Contributors: Admin, Ekrasovec, Orsyx, SBCNE, Sergio95810, Shawndouglas, Slclab, Softwarepoint, TC, 1 anonymous edits

ELN vendor Source: http://limswiki.org/index.php?oldid=23084 Contributors: Aacharya, Admin, Atgclabs, Invasifspecies, Jsdraw, Mbraspen, Mukunth, NicolasCARPi, Shawndouglas, 2
anonymous edits

CDMS vendor Source: http://limswiki.org/index.php?oldid=15988 Contributors: Shawndouglas, 1 anonymous edits

Article Sources and Contributors 219

SDMS vendor Source: http://limswiki.org/index.php?oldid=22955 Contributors: Mukunth, Shawndouglas, 2 anonymous edits

Image Sources, Licenses and Contributors 220

Image Sources, Licenses and Contributors

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Chen Y, Wang W, Zhou Y, Shields R, Chanda S, Elston R, Li J
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