Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance (1) - Couverture rigide

Couverture rigide

ISBN 10 : 1032981083 ISBN 13 : 9781032981086

Editeur : CRC Press, 2026

Synopsis

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.

A propos du livre

À propos de l?auteur

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.

Détails de l'édition

• Éditeur: CRC Press
• Date d'édition: 2026
• Langue: anglais
• ISBN 10: 1032981083
• ISBN 13: 9781032981086
• Reliure: Relié
• Numéro d'édition: 3
• Nombre de pages: 440
• Éditeur: Wingate Guy
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible