Pharmaceutical Computer Systems Validation
CRC Press (Verlag)
9781032981109 (ISBN)
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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.
Guy Wingate, PhD, was Vice-President of Compliance at GlaxoSmithKline until his recent retirement. A well-known speaker on computer validation, Dr Wingate has over 30 years’ experience in the pharmaceutical industry. He has been a visiting lecturer at the University of Manchester’s M.Sc. Pharmaceutical Engineering Advanced Training program and Dublin Institute of Technology’s accredited M.Sc. Validation Science program. Dr Wingate is an active member of the ISPE and was chair of the GAMP Council for 10 years which is responsible for the internationally recognized suite of GAMP Guides on computer compliance. Dr Wingate’s extensive list of published work includes the books Validating Corporate Computer Systems and previous editions of this book Pharmaceutical Computer Systems Validation.
Foreword. Preface. List of Contributors. About The Editor. Abbreviations. Chapter 21: Case Study 1: Clinical Systems. Chapter 22: Case Study 2: Computerized Analytical Laboratory Systems. Chapter 23: Case Study 3: Chromatography Data Systems. Chapter 24: Case Study 4: Laboratory Information Management Systems. Chapter 25: Case Study 5: Process Instrumentation. Chapter 26: Case Study 6: Process Control Systems (Operational Technologies: OT). Chapter 27: Case Study 7: Process Analytical Technology. Chapter 28: Case Study 8: Manufacturing Execution Systems and Electronic Batch Records. Chapter 29: Case Study 9: Building Management Systems. Chapter 30: Case Study 10: Spreadsheets. Chapter 31: Case Study 11: Database Applications. Chapter 32: Case Study 12: Electronic Document Management Systems. Chapter 33: Case Study 13: Enterprise Resource Planning Systems. Chapter 34: Case Study 14: Marketing and Supply Applications. Chapter 35: Case Study 15: IT Infrastructure and Associated Services. Chapter 36: Case Study 16: Big Data Management. Chapter 37: Case Study 17: Web-based Applications. Chapter 38: Case Study 18: Blockchain. Chapter 39: Case Study 19: Mobile Devices. Chapter 40: Case Study 20: Medical Devices and Their Automated Manufacture. Chapter 41: Case Study 21: AI-enabled Computerized System. Chapter 42: Case Study 22: Blood Establishment Computer Systems. Glossary. Index
| Erscheint lt. Verlag | 26.5.2026 |
|---|---|
| Reihe/Serie | Drugs and the Pharmaceutical Sciences |
| Zusatzinfo | 36 Tables, black and white; 1 Line drawings, color; 97 Line drawings, black and white; 1 Halftones, color; 15 Halftones, black and white; 2 Illustrations, color; 112 Illustrations, black and white |
| Verlagsort | London |
| Sprache | englisch |
| Maße | 178 x 254 mm |
| Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin |
| Naturwissenschaften ► Biologie | |
| Technik | |
| ISBN-13 | 9781032981109 / 9781032981109 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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