Pharmaceutical Computer Systems Validation Volume 1
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
Pharmaceutical Computer Systems Validation Volume 2
Foreword
Preface
List of Contributors
About The Editor
Abbreviations
Chapter 1: Case Study 1: Clinical Systems
Chris Clark, Guy Wingate
Chapter 2: Case Study 2: Computerized Analytical Laboratory Systems
Ludwig Huber
Chapter 3: Case Study 3: Chromatography Data Systems
Bob McDowall
Chapter 4: Case Study 4: Laboratory Information Management Systems
Christopher Evans
Chapter 5: Case Study 5: Process Instrumentation
Peter Coady, Tony de Claire
Chapter 6: Case Study 6: Process Control Systems (Operational Technologies: OT)
Mark Cherry
Chapter 7: Case Study 7: Process Analytical Technology
Guy Wingate
Chapter 8: Case Study 8: Manufacturing Execution Systems and Electronic Batch Records
Guy Wingate, Neil Wincup
Chapter 9: Case Study 9: Building Management Systems
John Andrews, Mark Foss
Chapter 10: Case Study 10: Spreadsheets
David Harrision
Chapter 11: Case Study 11: Database Applications
Thana Subramanian
Chapter 12: Case Study 12: Electronic Document Management Systems
Robert Stephenson
Chapter 13: Case Study 13: Enterprise Resource Planning Systems
Chris Reid, Guy Wingate
Chapter 14: Case Study 14: Marketing and Supply Applications
Louise Killa
Chapter 15: Case Study 15: IT Infrastructure and Associated Services
Chris Reid
Chapter 16: Case Study 16: Big Data Management
Guy Wingate, Neil Winkcup
Chapter 17: Case Study 17: Web-based Applications
Winnie Cappucci, Arthur (Randy) Perez
Chapter 18: Case Study 18: Blockchain
Sam Andrews
Chapter 19: Case Study 19: Mobile Devices
Guy Wingate
Chapter 20: Case Study 20: Medical Devices and Their Automated Manufacture
Guy Wingate, Tom Ryan
Chapter 21: Case Study 21: AI-enabled Computerized System
Tom Williams, David Cristinacce
Chapter 22: Case Study 22: Blood Establishment Computer Systems
Joan Evans
Glossary
Index
Biography
Guy Wingate, PhD, was Vice-President of Compliance at GlaxoSmithKline until his recent retirement. A well-known speaker on computer validation, Dr Wingate has over 30 years’ experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. Pharmaceutical Engineering Advanced Training program and Dublin Institute of Technology’s accredited M.Sc. Validation Science program. Dr Wingate is an active member of the ISPE and was chair of the GAMP Council for 10 years which is responsible for the internationally recognized suite of GAMP Guides on computer compliance. Dr Wingate’s extensive list of published work includes the books Validating Corporate Computer Systems and previous editions of this book Pharmaceutical Computer Systems Validation.
