Pharmaceutical Computer Systems Validation

Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance
3. Auflage 2026
ISBN: 978-1-032-98108-6
Verlag: Taylor & Francis Ltd

Buch, Englisch, 528 Seiten, Format (B × H): 178 mm x 254 mm, Gewicht: 1140 g

Reihe: Drugs and the Pharmaceutical Sciences

Computerized systems play a fundamental role in the development, manufacture and supply of medical treatments. This is the third and thoroughly updated edition of the best-selling book dealing with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a comprehensive walk-through of lifecycle and development methodologies bringing together technological advances, latest regulatory requirements, inspection findings, and compliance strategies. New chapters have been added on agile development methodologies, data integrity, artificial intelligence and machine learning. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing and supply chain systems with new contributions on databases, spreadsheets, LIMS, blockchain, mobile devices, AI-enabled systems, big data and digital twins authored by various industry experts.

Key Features

- Covers governance framework, roles and responsibilities, quality culture, project life cycle, operational compliance, risk management, electronic records/signatures, supplier management, practical troubleshooting, handling regulatory inspections, metrics, and opportunities for performance improvement.

- Provides a set of 22 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice.

- Focuses on GxP regulatory requirements covering GCPs, GLPs, GMPs, and GDPs—complete with observations from inspections by the U.S. FDA and other regulators.

- Discusses industry regulations and guidance, including current thinking of the U.S. FDA on computer software assurance, the latest guidance from the U.S. FDA/EU/MHRA on data integrity, and the newly published ISPE GAMP 5 Guide (Second Edition).

- Shares the practical experience and advice from a group of leading computer validation and compliance international experts.

Zielgruppe

Postgraduate, Professional Practice & Development, Professional Reference, and Undergraduate Advanced

Autoren/Hrsg.

Wingate, Guy

Fachgebiete

• Mathematik | Informatik EDV | Informatik Computerkommunikation & -vernetzung Cloud-Computing, Grid-Computing
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Naturwissenschaften Chemie Chemie Allgemein
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

Inhaltsverzeichnis

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

Über Autor(innen)

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.