Computerised 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 organizational responsibilities, project lifecycle, operational compliance, risk management, data integrity, practical trouble shooting, handling regulatory inspections, metrics and the opportunity for performance improvement.
- Includes 20 new and updated case studies by industry experts, demonstrating how these computer system validation principles are put into practice.
- Discusses industry regulations and guidance including current thinking of US FDA on computer software assurance, the latest guidance from US FDA/EU/MHRA on data integrity and newly published ISPE GAMP 5 Guide (Second Edition).
- Focuses on regulatory requirements covering GCPs, GLPs, GMPs and GDPs – complete with observations from inspections by US FDA and other regulators
- Includes new material dealing with the latest advancements concerning data integrity, machine-learning and artificial intelligence, data-lakes, cloud computing services, mobile devices, and IT tools.
This new edition deals with validation, compliance and software in the pharmaceutical, healthcare and medical device industries. The first volume provides a walk-through of lifecycle and development methodologies, and the second volume comprises a set of refreshed case studies spanning laboratory, manufacturing and supply chain systems.
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
Guy Wingate, PhD, was Vice President & Compliance Officer and before that Director Global Computer Validation at GlaxoSmithKline until his recent retirement. A wellknown 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 Manchesters M.Sc. in Pharmaceutical Engineering Advanced Training program and the Dublin Institute of Technologys 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.
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