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Auditing Computerised Systems

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This booklet has been produced by the RQA Computing Committee to provide guidance on current best practice in the auditing of computerised systems. The principles are applicable to all computerised systems audits, but particularly those used within the pharmaceutical industry.


  1. Foreword
  2. Acknowledgement
  3. Introduction
  4. Objective
  5. The System Life Cycle (SLC)
  6. Risk Management
  7. Validation Deliverables
  8. Change Control 
  9. Planning an Audit 
  10. Audit Types 
  11. The Principles of Data Integrity 
  12. Archiving Principles 
  13. Regulations and Guidance 
  14. References 
  15. Appendix I – Computerised System Audit Checklists 
  16. Appendix II – Definitions and Acronyms


Christopher Montgomery and the RQA Computing Committee




January 2013

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