GAMP Americas - JETT Sample Docs

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NOTE: We are in the process of updating documents to latest versions, so check back frequently.

We want your feedback! Please send us any feedback you have regarding our Sample Documents. We would also appreciate you sending us your completed templates to use as part of our continuous improvement process.

Please send comments or completed templates to Chris Roerig or Mike Filary

Disclaimer:
This documentation is for reference only and is not intended to replace good engineering practice and design necessary to apply equipment to a given process. The user is responsible for any and all consequences of the design and application of the equipment. In no manner is JETT or any of the members of JETT liable for any situation by use of these documents.

Copyright Note:
The documents on this page are given freely to the public, and all copyrights are thereby waived. The public is free to utilize this documentation as the guidelines they are intended to be. 

General Instructions: 
All guidelines may be viewed using Microsoft WordTM 97 or higher version. Click on the documentation link to upload the document to your computer. For comments or feedback regarding these documents, contact Mike Filary, revision control lead at michael.filary@perfval.com.

Note:
The URS contents template is designed to be used in conjunction with the URS blank template developed by the Joint Equipment Transition Team (JETT) in accordance with current GAMP guidance. The numbering system used in the URS contents template match the sections by number in the JETT URS blank template. The URS contents template only includes the following sections:

  • 1.0 Introduction (Scope)
  • 2.0 Overview
  • 3.0 Operational Requirements

The other sections included in the URS blank template are typically boiler-plate and will only require minimal modification for specific end users. There is also an description on the URS development procedure.


Released Documents

Misc. Documents

Example URS (User Requirements Specifications)


Documents in draft form

 
Wide Range Filler Example GAMP Document Set

  • URS ( 415 KB)
    User Requirements Specification (8/03)
  • FS ( 570 KB)
    Functional Specification (8/03)
  • DS ( 485 KB)
    Design Specification (8/03)
  • RTM ( 361 KB)
    Requirements Traceability Matrix (8/03)
  • APP ( 32 KB)
    Appendix (8/03)
  • Test Map Cover ( 34 KB)
    Explanation of the purpose and definitions of terms used in the Test Map Document (8/05)
  • Test Map Spreadsheet ( 35 KB)
    Consolidated Test plan showing all testing done from internal checkouts and Commissioning through Qualification Tests (8/05)

Indicates content available to ISPE members only.
Last Update: 08 October 2013

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