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Computerised System Validation (CSV): Risks, Requirements, Tests and Traceability

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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'.


  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


Chris Montgomery and the RQA Computing Committee


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First printed December 2008

Reviewed January 2013


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Computerised System Validation (CSV): Risks, Requirements, Tests and Traceability