ISPE CCCh24-25Jan2006BASLifecycleOverviewGAMP

ISPE Central Canada Chapter
BAS Lifecycle Overview using GaMP
January 24, 2006 Toronto

January 25, 2006 Montreal
Irene Miess Sr Manager Regulated Industries

Siemens Building Technologies
Company Confidential
BAS Lifecycle Overview using GaMP
GaMP Model
System Impact Assessment
Direct Impact Systems

Indirect Impact Systems
Good Engineering Practice

Commissioning
Qualification Practices
Installation and Operational Qualification
Documentation Requirements
Ongoing Operation
Good Automated Manufacturing Practice (GaMP)
As a regulated site supplier, what guidance do we have in

delivering a validated and compliant system?
Design & Commissioning Ongoing

Planning Installation
Development & Qualification Operation
FAT
NO
Required? Good Automated Manufacturing
Practice (GaMP)
GaMP provides a method to relate
YES
development activities to validation
Factory activities on automated systems using a
Acceptance life cycle approach
Testing
Good Automated Manufacturing Practice (GaMP)
GaMP was created due to:

the increased use and complexity of automated systems in FDA regulated
manufacturing areas
the less mature interpretation of regulations in automated applications

than in more conventional, non-automated areas
GaMP benefits FDA regulated companies by:

Improving the understanding & interpretation of regulations
Providing established guidelines for
suppliers of automated systems
Clarifying the division of responsibility

between user and supplier
Reducing the cost and time taken to

achieve compliant systems
A GaMP Industry Board establishes
GaMP principles and recommendations
Project Lifecycle (GaMP)

FAT
NO
Required?
YES
Factory
Acceptance
Testing
Planning and Design/Development Phases
Master Validation Plan

(MVP)
Planning
Phase
User Requirement Impact
Specification (URS) Assessment
Quality System Program Functional Specification

and Implementation Plan Hardware Software
Engineering Submittal Design &

Development
Hardware Software Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
The Validation Master Plan (VMP) is the key document in the overall
validation process, and is critical to the success of the project. It is an
important project document and a living document that must be
maintained throughout the project life cycle.
The validation master plan typically defines:
Validation Strategy
Validation Deliverables
Acceptance Criteria
Change Control Management
Standard Operating Procedures
Training
Documentation Management
Maintaining a Validated State
BAS needs to be addressed
Monitor & Alarm only
Direct Impact only
If you want tomatoes,
dont plant turnips!

(MVP)
Planning
Phase


Development
Factory
Acceptance Test
(FAT) Phase
User Requirements
The User Requirement Specification (URS) specifies the

requirements of the user for individual aspects of the facility,
equipment, and systems in terms of function, throughput,
operability, and applicable standards
Defines what the user wants the system to do. What functions
will be carried out, the data on which the system will operate,
and the operating environment. Non-functional requirements,
such as constraints (that is, time) and what deliverables will be
provided by the system (that is, Training, Testing, Tools), are
also documented
The User Requirement Specification (URS) and Performance
Testing are linked. The URS provides the performance
benchmark criteria upon which the performance qualification
(PQ) is based
BAS User Requirement Spec
Do you want
to follow GaMP
traceability matrix
functional specs
testing
calibratable sensors
commissioning documents
remote notification
horn/bell
paging

(MVP)
Planning
Phase


Development
Functional Design
Factory
Acceptance Test
(FAT) Phase
Impact Assessment
A process which allows a complex situation of interdependent

engineering systems and components to be reviewed,
understood and systematically evaluated for their effect on
product quality (Commissioning vs. Qualification).
Relationship Between Systems and Components
Components
Critical Non-Critical
Direct
Good
Impact Engineering
Practices +
Systems Qualification
Practices
Indirect/
No Impact 8 Good
Engineering
Practices +
Commissioning
System Level Assessment
System: An organization of engineering components

which have defined operational function (e.g., piping,
instrumentation, equipment, facilities, computer hardware,
computer software, etc.)
System Boundary: A limit drawn around a system to

logically define what is and is not included in the system.
Direct Impact System: An engineering system that is

expected to have a direct impact on product quality.
Indirect Impact System: An engineering system that is

not expected to have a direct impact on product quality,
but is linked to a direct impact system.
No Impact System: An engineering system that is not

expected to have an impact on product quality.
System Impact Assessment: The process of evaluating

the impact of the operating, controlling, alarming and
failure conditions of a system on the quality of a product.
The quality of the product can be impacted by a system
or systems which meets any of the following criteria:
In contact with the product
Used as an excipient
Controls the process or
Provides information relative to product acceptance or
rejection
Component Level Assessment
Critical Component: A component within a system

where the operation, contact, data, control, alarm or
failure will have a direct impact on the quality of the
product.
Non-Critical Component: A component within a system
where the operation, contact, data control, alarm or
failure will have an indirect or no impact on the quality of
the product.
Relationship Between Systems and Components
Components
Critical Non-Critical
Direct
Good
Impact Engineering
Practices +
Systems Qualification
Practices
Indirect/
No Impact 8 Good
Engineering
Practices +
Commissioning
BAS Draw Boundaries
HVAC
BAS only
AHU controls
zone controls
monitor & alarm
Design system accordingly

Separation by panels
Separate GMP from non GMP
Where are YOUR Boundaries
Sample P&ID of HVAC and BAS Equipment


(MVP)
Planning
Phase


Development
Factory
Acceptance Test
(FAT) Phase
Quality System Program and Implementation Plan
The Quality System Program and Implementation Plan is

a contractual document between the Client and BAS
supplier.
Defines actions, deliverables, responsibilities, and

procedures satisfying the user quality and validation
requirements.

(MVP)
Planning
Phase


Development
Factory
Acceptance Test
(FAT) Phase
Functional Requirements Specification
The Functional Requirements Specification (FRS) describes the

detailed functions of the facility, equipment, and system (i.e.,
what the system will do).
The Functional Specification is normally written by the Supplier

and then reviewed and approved by the Customer.
The FRS is used to develop the Acceptance Test Specification

that outlines those items to be tested as part of the Factory
Acceptance Test (FAT) and/or Site Assessment Test (SAT).

(MVP)
Planning
Phase


Development
Factory
Acceptance Test
(FAT) Phase
Design Specification
The Design Specification (DS) document developed by Supplier

describes how to build the facility, equipment, and system (that
is, how to design or construct the system).
It is recommended that the Design Specification is illustrated by

the use of diagrams wherever possible.
The Design Specification is normally written by the Supplier

and then reviewed and approved by the Customer.
In most cases the DS may be included in the FS

(MVP)
Planning
Phase


Development
Linked to Hardware Software Phase
Installation
Qualification (IQ) Customer Approval of
Linked to
Operational
Qualification (OQ)
Factory
Linked to Acceptance Test
Performance (FAT) Phase
Qualification (PQ)

FAT
NO
Required?
YES
Factory
Acceptance
Testing

FAT
NO
Required?
YES
Factory
Acceptance
Testing
FAT and Installation Phases
Factory
NO Acceptance
Test (FAT)
Required? Factory Acceptance
Test (FAT) Phase
YES
BUILD SYSTEM
Factory Acceptance Test

(FAT)
BUILD SYSTEM Installation at Job Site Develop Installation Phase

IQ/OQ/PQ Tests
Develop
Commissioning Plan
Commissioning& Qualification Phase
FAT and Installation Phases
Factory
NO Acceptance
Test (FAT)
Required? Factory Acceptance
Test (FAT) Phase
YES
BUILD SYSTEM
Factory Acceptance Test

(FAT)
BUILD SYSTEM Installation at Job Site Develop Installation Phase

IQ/OQ/PQ Tests
Develop
Commissioning Plan
Commissioning& Qualification Phase
Factory Acceptance Test (FAT)
A FAT is recommended when the project deadline is critical

and construction schedule does not allow enough time for
commissioning and validation after installation.
Combining the commissioning findings with the FAT as part of
the validation process helps avoid collecting data twice, making
better use of time and project resources.
Other tests used during the FAT and SAT may be used to support
the validation effort.
The request for the FAT occurs during the planning stage of a
project and usually is included in the Validation Master Plan and
the Request for Quote (RFQ).

FAT
NO
Required?
YES
Factory
Acceptance
Testing
Commissioning/Qualification Phase & Ongoing Ops
Start-up & Commissioning
Site Acceptance Test (SAT) Commissioning &

Qualification Phase
DIRECT IMPACT INDIRECT & NO

SYSTEMS IMPACT SYSTEMS
Installation Trending to verify

Qualification (IQ) operational changes
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Change Control Document Control

Ongoing
Standard Operations (SOPs) Training Operations
Maintenance Operations Business Continuity

Impact Assessment
GEP Only
Parking Facilities No Impact
Office Terminal Devices
Office HVAC Systems
Chilled Water Systems Indirect Impact?

cGMP HVAC Systems
Building Management System
cGMP Terminal Devices Direct Impact

GEP and
Qualification
Commissioning Plan
IMPACT ASSESSMENT GEP COMMISSIONING GEP / QUALIFICATION IQ / OQ
DOCUMENTATION
Parking Facility Vendor Standard X
Office Terminal HVAC Vendor Standard X

Equipment
Office Central HVAC Vendor Standard X

Equipment
Chilled / Hot Water Vendor Standard X

Systems
Building Automation Vendor Standard X Enhanced Documentation X

System / FAT?
cGMP Central HVAC X Enhanced Documentation X

Critical Systems
cGMP Terminal HVAC X Enhanced Documentation X

Critical Systems
Other Validated Ancillary X Enhanced Documentation X

Systems
Commissioning
A well planned, documented and managed engineering

approach to the start-up and turnover of facilities, systems
and equipment to the end-user that results in a safe and
functional environment that meets established design
requirements and stakeholders expectations.
Commissioning
Concepts:
Requires close cooperation of a multi-disciplined team
Builds on concepts and activities such as Impact Assessment

and Good Engineering Practices
Execution typically occurs after the installation of equipment,

piping and instrumentation is complete and operational
Systems, equipment and instrumentation need to be physically

complete and operational
Commissioning Plan
Agree on the Commissioning Plan early in the project

Plan should identify systems to be commissioned, activities and
sequences, deliverables, personnel and organizations involved
and their roles/responsibilities
Provide list of facilities, utilities and equipment to be commissioned
Approvers should include Design, Construction and the End-User
representatives; include Validation and QA for direct impact
systems
Commissioning should be integrated with qualification activities for
direct impact systems
Commissioning may be the final activity prior to use/operation by
the end-user
Plan for either phased or one-time turnover
Commissioning Process
Levels of commissioning for building automation systems:

Standard Commissioning
Enhanced Commissioning
The level of commissioning is defined in the VMP and Quality

Plan.
Direct Impact systems require enhanced documentation, which
may involve additional tests, documentation, QA change control,
and QA review/approval. Enhance documentation should
complement (not repeat) the documentation that is created
through GEP.

Qualification Phase


Operational
Qualification (OQ)
Performance
Qualification (PQ)

Ongoing

Site Acceptance Test
Tests that are completed On-site with installed

equipment to prove the correct operation of the
software, hardware, and instrumentation as defined
by the URS
Site Acceptance Test
The Site Acceptance Test (SAT) is performed to determine that the

system and any associated equipment has not been damaged and
functions correctly in its operating environment.
The SAT normally constitutes a repeat of the FAT (or portions of the
FAT) in the users environment plus those test made possible with all
process, field instrumentation, interfaces, and service connections
established.
The SAT may be combined with equipment and plant

commissioning, and this will provide a basis for the IQ and OQ.
The incorporation of SAT into qualification testing is acceptable

where the level of detail and documentation of the tests meet the
requirement of user company policies and procedures, and are
acceptable to user company QA.

Qualification Phase

Operational
Qualification (OQ)
Performance
Qualification (PQ)

Ongoing

BAS Installation Qualification Table of Contents
Documentation Verification
SOP Verification
Hardware and Software Verification
Field Panel
Hardware and Firmware Verification
Utility Verification
Application Code Version Verification
Installation Qualification Table of Contents
Database Configuration Verification
Trend Configuration Verification
Trend Collection Schedule Verification
Alarm Configuration Verification
Point Configuration Verification
Alarm Management Configuration Verification

Remote Notification Configuration Verification
Alarm Paging Notification Verification

Point List Verification
Installation Qualification Table of Contents
Archive Database Configuration Verification
Data Base Verification
Data Server Configuration Verification
Archive Schedule Verification
Data Purge Configuration Verification
Summary Point Configuration Verification
Uninterruptible Power Supply Installation Verification
Field Device Calibration Verification
Field Equipment Installation Verification

Qualification Phase

Operational
Qualification (OQ)
Performance
Qualification (PQ)

Ongoing

Operational Qualification Table of Contents
System Security Qualification Test Cases

User Account Security
Access Groups
Audit Trail Qualification Test Cases
Audit Trail Verification
Long Term Storage of Audit Trails
Field Panel Qualification Test Cases
Field Panel Loss of Communication
Field Panel Battery Check
Field Panel Power Failure Alarming and Recovery
Electric Field Instrument (EFI) Interference
Uninterrupted Power Supply
Custom Code Testing
Scheduled Functions Qualification Test Cases
Trend Collection Report Verification
Data Server Verification
Archive Schedule Verification

System Alarms Qualification Test Cases
Standard Alarm Notification Test
Enhanced Alarms Notification Test
Remote Notification Qualification Test Cases
Building Level Network Event
Escalation Test
Alarm Management Qualification Test Cases
Alarm Management Operational Test Case
Alarm Management Archival Test Case
Data Integrity Qualification Test Cases
Transmitter Failure Test
72 Hour Trend Analysis
Linked to User
Requirements Spec Start-up & Commissioning
Linked to Functional
Requirements Spec
Linked to Design
Qualification Phase
Spec


Operational
Qualification (OQ)
Performance
Qualification (PQ)

Ongoing

Standard Operating Procedures (SOPs)
System Operation
Change Control/ Upgrade Procedures
Hardware Maintenance Procedures
Software Maintenance Procedures
Electronic Records/Data Management Procedures
Incident Management Procedures
System Security Procedures
Training Procedures
Disaster Recovery Procedures
Source Code Handling
The V-Model:
A Basic Framework for Specification, Design and Testing
User Requirements PQ Test Plan Performance

Specification Qualification
Functional OQ Test Plan Operational

Specification Qualification
IQ Test Plan Installation

Design Specification
Qualification
System Build
IQ/OQ
Pre-Approved Protocol
Installation Operation Performance

Direct Impact
Systems
Critical Devices Calibration
<
< Change
< Control
Indirect/
No Impact
Systems
Point to Point Start Up Trending
Non-Critical
Devices
Forms with Signatures & Dates
Related
Specifications
Design Functional User Requirement
Specification Specification Specification
Questions??
If you want tomatoes

Dont plant turnips!
Siemens Building Technologies
Irene Miess
847-941-5840
irene.miess@siemens.com
Dave Barrett
905-799-9937
david.barrett@siemens.com

ISPE CCCh24-25Jan2006BASLifecycleOverviewGAMP

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ISPE Central Canada Chapter

BAS Lifecycle Overview using GaMP

January 24, 2006 Toronto

Irene Miess Sr Manager Regulated Industries

System Impact Assessment

Direct Impact Systems

Good Engineering Practice

As a regulated site supplier, what guidance do we have in

Design & Commissioning Ongoing

GaMP was created due to:

the less mature interpretation of regulations in automated applications

GaMP benefits FDA regulated companies by:

Clarifying the division of responsibility

Reducing the cost and time taken to

Design & Commissioning Ongoing

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &

BAS needs to be addressed

Monitor & Alarm only

Direct Impact only

If you want tomatoes,

dont plant turnips!

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &

The User Requirement Specification (URS) specifies the

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &

A process which allows a complex situation of interdependent

System: An organization of engineering components

System Boundary: A limit drawn around a system to

Direct Impact System: An engineering system that is

Indirect Impact System: An engineering system that is

No Impact System: An engineering system that is not

System Impact Assessment: The process of evaluating

Critical Component: A component within a system

monitor & alarm

Design system accordingly

Separate GMP from non GMP

Sample P&ID of HVAC and BAS Equipment

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &

The Quality System Program and Implementation Plan is

Defines actions, deliverables, responsibilities, and

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &

The Functional Requirements Specification (FRS) describes the

The Functional Specification is normally written by the Supplier

The FRS is used to develop the Acceptance Test Specification

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &

The Design Specification (DS) document developed by Supplier

It is recommended that the Design Specification is illustrated by

The Design Specification is normally written by the Supplier

In most cases the DS may be included in the FS

Master Validation Plan

Quality System Program Functional Specification

Engineering Submittal Design &