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URS PREPARATION PROCESS Doc ID:

JETT 371760693.doc
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URS PREPARATION PROCESS

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URS PREPARATION PROCESS Doc ID:
JETT 371760693.doc
March 27, 2002

REVISION HISTORY
Rev. Date Approval Revision Summary

A 28/3/2002 Draft Version

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Table of Contents
1.0 PURPOSE.........................................................................................................................4
2.0 PROCESS........................................................................................................................4
3.0 Typical Interview Questionnaire Topics...........................................................................6

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1.0 PURPOSE
This document is intended for organizations evolved in the preparation of a User Requirements
Specification (URS) document for automated manufacturing or process equipment. It presents
the JETT Consortium recommended process for gathering, defining and documenting the users
requirements.
Additional guidance may be found in ISPEs GAMP Guide for Validation of Automated
System, GAMP4, Dec. 2001.

2.0 PROCESS
2.1 Identify Roles
As a first step, it is important to identify an individual who represents the end-users of a
desired manufacturing or process equipment solution.
The role of this individual will be to act as a primary contact and project coordinator for
the organization involved in the URS preparation. The same individual will help in the
identification of resources and groups that will participate to the interview process and
will facilitate the scheduling of those interviews.
It is also the role of the Project Coordinator to clearly identify who will be the reviewers
and the approvers of the formal URS document. The roles and responsibilities of these
individuals involved in the preparation of the URS should be clearly stated in the URS
document.

2.2 Define the Scope

It is imperative that the scope to be covered by the URS be clearly defined and agreed
upon. Boundaries and exclusions in the functionality, data, interface and environment
sections must be clearly identified and documented in the URS document.
In order to properly define the scope, the author(s) of the URS will refer to documents
such as a project proposal, a formal problem statement, a value proposition, conceptual
design documents and other sources whenever applicable, and will also discuss with the
project coordinator or the targeted system owner(s).
A schematic representation of the desired solution should be considered for inclusion in
the URS for sake of clarity.

2.3 Identify participants to the Interview Process and Schedule Interviews

In order for the URS to properly describe the users requirements, it is important that a
number of resources and potential users be interviewed. The interviews will help define
the expected functionality, the environment, the operational constraints, company
policies and applicable regulations.

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It is important to interview individuals that cover a broad range of functions, not limited
to immediate potential users. Individuals involved in Operations, Information
Technology (IT), Engineering, Management, Quality Assurance and Maintenance should
be included in the interview process.
The project coordinator shall facilitate and possibly make all arrangements for
scheduling all interviews and work sessions required for gathering the information.

2.4 Prepare Interview Questionnaires

In order for the interviews to be efficient and complete, questionnaires shall be prepared.
The questionnaires shall include questions related to all major sections of the URS, as
defined in the document BLANK URS TEMPLATE_RevA8.doc or other agreed upon
template. Questionnaires shall also be adapted depending on the function performed by
the individuals participating in the interview process. Typical topics are provided in
Section 3 of this document as a starting base for building a questionnaire.
The project coordinator may consider sending the Interview Questionnaire as part of the
interview schedule confirmation to allow individuals to better prepare and possibly
gather documents that could be used as references.
The interview process could also take the form of brainstorming work sessions. In such
case, a document including the meeting agenda and background information shall be
prepared and sent to participants to lead the discussions in an organized manner.

2.5 Conduct Interviews and Work Sessions

When many individuals representing the same function are to be interviewed, for
example, operators and supervisors of the same operations department, it is
recommended that these individuals be interviewed as a group to favor synergy.
Questionnaires must be used for all interviews and notes must be taken during the work
sessions to ensure that the discussions are well documented. Minutes of meeting
presenting a summary of the requirements expressed during the interview should be
submitted to all interviewed participants to ensure there is no false interpretation on the
needs and requirements. Additional questions may be presented to the participants at that
point to complement or confirm gathered information.

2.6 Analyze Data and Prepare Draft Version of the URS Document
Once all interviews are completed, or as a continuous development effort during the
interview process, the URS document shall be prepared using the BLANK URS
TEMPLATE_RevA8.doc document template and other agreed upon template. No
sections / sub-sections shall be deleted and all shall be filled. In the case where no
requirement applies to a particular section or sub-section, the description shall specify
"Not applicable".
At this point, it is required to clearly and precisely describe what the users want the
manufacturing or process equipment to do, and distinguish between essential

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requirements and merely desirable features. There should be no ambiguity in the

expectations of the users.
Additional guidance may be found in Appendix D1 of ISPEs GAMP Guide for
Validation of Automated System, GAMP4, Dec. 2001.

2.7 Submit Draft Version for Review

The draft version of the URS document shall be sent for review to the agreed upon list of
reviewers based on the organization document management policy.
A reasonable period of time shall be allowed to all reviewers to complete the review
process and submit changes or comments. Required changes or comments shall be
submitted in writing or formally documented by the author(s) in the case where the
changes/comments are expressed verbally. Additional meetings may be required to
discuss proposed changes or comments.

2.8 Submit Formal Version for Approval

At the end of the draft version review period, author(s) shall incorporate agreed upon
changes and comments and submit the formal version of the URS in printed form to all
URS approvers.
It shall be noted that the URS will be subject to reviews throughout the manufacturing or
process equipment life cycle and shall therefore be subject to change control.
All formal copies of the URS document with approvers' signature shall be retained.
Additional Good Documentation Practice are presented in ISPEs GAMP Guide for
Validation of Automated System, GAMP4, Dec. 2001.

3.0 TYPICAL INTERVIEW QUESTIONNAIRE TOPICS

The following topics shall be considered when preparing an interview questionnaire:

3.1 Management Topics

Identification of organizations goals and objectives
Expected benefits
Budget and resources
Time, security, procedural and maintenance constraints
Existing infrastructure, policies and practices
Contract and Services agreement

3.2 Operations Topics

Intended equipment usage (range of products, production rates, availability, etc.)

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Environmental constraints (physical location, room classification, vibration,

temperature, altitude, cleaning, etc.)
Profile of users (functions, skills, experience, language, training, etc.)
Modes of operation
Desired functionalities
Security and safety
Reliability and redundancy constraints
Scalability
Automated system and database technologies
Preferred equipment and components manufacturers
Existing engineering documentation standards or conventions.

3.3 Equipment Topics

Production and quality performance
Components assembly and construction
Operators and external systems interface (hardware and software platforms,
network protocols to be supported, etc.)
Utilities (control air, process water, electricity, etc.)
Equipment configuration and setup
Development, testing and maintenance tools
Alarms, events, messages and reports
Training, maintenance and qualification documentation
Data recording, time stamping, handling, access and storage
System backup and restore
Remote access and administration

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