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Computerised System Validation Booklet

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This booklet has been produced by the RQA Computing Committee to provide guidance on current best practice and the application of risk management in Computerised System Validation. The Principles are applicable to all regulated computerised systems, particularly those used within the pharmaceutical industry.

Much of the information within this booklet has been developed concurrently with the RQA Professional Development Course on 'Auditing Computerised Systems' and 'Computerised System Validation'.

Contents

  1. Introduction
  2. The Validation Process
  3. The Regulations
  4. Risk Management
  5. Project Deliverables
  6. Validation Process
  7. Qualifications
  8. Validation Strategy
  9. Appendix A - Example User Requirements Specification
  10. Appendix B - Example Functional Design Specification
  11. Appendix C - Example System Design Specification
  12. Appendix D - Example Traceability Matrix
  13. Appendix E - Example Test Script
  14. Appendix F - References
  15. Appendix G - Example Architecture Diagram
  16. Appendix H - The Iterative or Prototyping CSV Model

Authors

Chris Montgomery and the RQA Computing Committee

ISBN

978-1-904610-20-5

Published

First printed December 2008

Reviewed January 2013

Discount Information

Discounts are available for bulk orders. Please enter one of the following discount codes:

  • 89BOOK10 for orders of 10 - 19 copies - 25% discount
  • BOOK20 for orders of 20 - 49 copies - 33% discount
  • BOOK50 for orders over 50 copies - 50% discount


This discount is available for both a block of one title or a combination of titles in hardback.

If ordering 50 or more books for delivery to outside the UK, please contact the RQA office as we will need to calculate the delivery cost for you.


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