Pharmaceutical Computer Systems Validation

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 and compliance of computer systems and software in the pharmaceutical, healthcare, and medical device industries.

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.

This edition of the book is split into two volumes. The first volume provides a comprehensive walk‑through of life cycle and development methodologies, bringing together technological advances, the 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 growing role of cloud computing services and IT tools is also discussed. The second volume comprises an extensive set of refreshed case studies spanning laboratory, manufacturing, and supply chain systems, authored by various industry experts, with new contributions on databases, spreadsheets, blockchain, mobile devices, AI‑enabled data lakes and digital twins.

This is the first of the two volumes that make up this book. The second volume of real-life case studies is available from the same publisher as a companion to this first volume.