Pharmaceutical Computer Systems Validation : Volume 1 - Quality Assurance, Risk Management and Regulatory Compliance

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.

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.