3rd Edition
Pharmaceutical Computer Systems Validation Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance
Foreword
Preface
About The Editor
Abbreviations
Chapter 1 Introduction
Chapter 2 Organization and Management
Chapter 3 Lifecycle Methodologies & Supporting Processes
Chapter 4 Prospective Verification and Validation
Chapter 5 Project Initiation and Compliance Determination
Chapter 6 Requirements Capture and Supplier (Vendor) Selection
Chapter 7 Design and Development
Chapter 8 Coding, Configuration, and Build
Chapter 9 Development Testing
Chapter 10 User Qualification and Authorization to Use
Chapter 11 Operation and Maintenance
Chapter 12 Phaseout and Withdrawal
Chapter 13 Data Integrity
Chapter 14 Regulated Electronic Records and Electronic Signatures
Chapter 15 Artificial Intelligence & Machine Learning
Chapter 16 Regulatory Inspections
Chapter 17 Compliance Strategies
Chapter 18 Capabilities, Measures, and Performance
Chapter 19 Practical Troubleshooting
Chapter 20 Concluding Remarks
Glossary
Index
Biography
Guy Wingate, PhD, was Vice President & Compliance Officer and before that Director Global Computer Validation at GlaxoSmithKline until his recent retirement. A well‑known speaker on computer validation, he has over 30 years of experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technology’s accredited M.Sc. in Validation Science program. He is an active member of the ISPE and served as Chair of the GAMP Council for 10 years, which is responsible for the internationally recognized suite of GAMP® Guides on computer compliance. Guy led the teams who produced the original GAMP®5 Guide: A Risk Based Approach to Compliant GxP Computerized Systems and the GAMP® Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures. His extensive list of published work also includes the books Validating Automated Manufacturing and Laboratory Applications, Validating Corporate Computer Systems and previous editions of this book Pharmaceutical Computer Systems Validation.
