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.
