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.

Contents

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

Authors

Christopher Montgomery and the RQA Computing Committee

ISBN

978-1-904610-22-9

Published

January 2013

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Booklets

Computerised System Validation
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P01 Introduction to Computer Systems Validation
P21 Audit Programmes and Risk Assessment
RP01 Introduction to Computer Systems Validation REMOTE LEARNING
RP21 Audit Programmes and Risk Assessment REMOTE LEARNING