3rd Edition
Pharmaceutical Computer Systems Validation Volume 2 - Real Life Case Studies
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, Ph.D., was Vice‑President of Compliance and before that Director of 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 Laroratoty Applications, Validating Corporate Computer Systems and previous editions of this book, Pharmaceutical Computer Systems Validation.
