Pharmaceutical Computer Systems Validation: Two Volume Set

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.

This book’s strong emphasis on governance, management oversight, and maintaining control throughout the operational life cycle [of computer systems used in the pharmaceutical industry] is both timely and necessary.A key challenge for today’s organizations today is the shift from validating systems at a point in time to assuring them continuously throughout their life. Modern development and delivery approaches, such as Agile and DevOps, can support this goal, but only when the supporting controls are designed deliberately and applied consistently. Clear intent of requirements, risk‐based decision‐making, appropriate testing strategies for high‐risk functions, robust release and configuration management, and effective supplier oversight remain essential. Several chapters in the book address these realities directly, focusing on the areas where compliance most often degrades: operation, maintenance, and change.At the same time, the regulatory and compliance landscape continues to evolve. There is sustained global focus on data governance and data integrity, including expectations for effective investigation, remediation, and prevention of recurrence. Cybersecurity, data availability, and business continuity are receiving increased attention, reflecting their direct impact on product quality and patient safety. Regulators also increasingly expect organizations to understand, control, and justify the use of emerging technologies, particularly where these technologies influence GxP decisions, regulated records, or regulatory submissions.What is particularly welcome about this book is its practical orientation. While regulations and guidance are widely available, many organizations struggle to translate high‐level principles into consistent execution across diverse system types and life cycle stages. This work helps to bridge that gap. Through its structured approach and breadth of examples, from laboratory and manufacturing systems to enterprise platforms, infrastructure, cloud services, and data‐intensive digital architectures, it provides practitioners with a coherent framework grounded in real operational experience.I would encourage readers to approach this book not simply as a compliance manual, but as a guide to building organizational capability. Capability means being able to explain, with confidence, how and why controls are proportionate to risk; demonstrating that systems are fit for their intended use; evidencing that data remain complete, consistent, and trustworthy throughout the data life cycle; and showing that the organization learns through effective management review, meaningful metrics, and a culture that treats issues as opportunities for improvement rather than occasions for blame.In an era of increasing digital dependence, this capability is not optional. It is fundamental to protecting patients, safeguarding product quality, and maintaining trust in the organizations responsible for both. I commend this book to practitioners, managers, and auditors alike, and I hope it serves as a practical companion in building the right environment, technical, procedural, and cultural, for robust computer compliance and data integrity.Tracy MooreFormer Expert GMP Inspector, UK Medicines & Healthcare products Regulatory Agency (MHRA)

• Pharmaceutical Computer Systems Validation Volume 1Foreword. 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. IndexPharmaceutical Computer Systems Validation Volume 2Foreword. Preface. List of Contributors. About The Editor. Abbreviations. Chapter 1: Case Study 1: Clinical Systems. Chapter 2: Case Study 2: Computerized Analytical Laboratory Systems. Chapter 3: Case Study 3: Chromatography Data Systems. Chapter 4: Case Study 4: Laboratory Information Management Systems. Chapter 5: Case Study 5: Process Instrumentation. Chapter 6: Case Study 6: Process Control Systems (Operational Technologies: OT). Chapter 7: Case Study 7: Process Analytical Technology. Chapter 8: Case Study 8: Manufacturing Execution Systems and Electronic Batch Records. Chapter 9: Case Study 9: Building Management Systems. Chapter 10: Case Study 10: Spreadsheets. Chapter 11: Case Study 11: Database Applications. Chapter 12: Case Study 12: Electronic Document Management Systems. Chapter 13: Case Study 13: Enterprise Resource Planning Systems. Chapter 14: Case Study 14: Marketing and Supply Applications. Chapter 15: Case Study 15: IT Infrastructure and Associated Services. Chapter 16: Case Study 16: Big Data Management. Chapter 17: Case Study 17: Web-based Applications. Chapter 18: Case Study 18: Blockchain. Chapter 19: Case Study 19: Mobile Devices. Chapter 20: Case Study 20: Medical Devices and Their Automated Manufacture. Chapter 21: Case Study 21: AI-enabled Computerized System. Chapter 22: Case Study 22: Blood Establishment Computer Systems. Glossary. Index