Pharmaceutical Computer Systems Validation: Two Volume Set
3rd Edition
Will be published approx. on 21. June 2027
Book
Paperback/Softback
970 pages
978-1-041-39060-2 (ISBN)
Description
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.
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
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
More details
Series
Edition
3rd edition
Language
English
Place of publication
London
United Kingdom
Publishing group
Taylor & Francis Ltd
Target group
College/higher education
Professional and scholarly
Postgraduate, Professional Practice & Development, Professional Reference, and Undergraduate Advanced
Illustrations
85 s/w Tabellen, 2 farbige Zeichnungen, 219 s/w Zeichnungen, 1 Farbfoto bzw. farbiges Rasterbild, 15 s/w Photographien bzw. Rasterbilder, 3 farbige Abbildungen, 234 s/w Abbildungen
85 Tables, black and white; 2 Line drawings, color; 219 Line drawings, black and white; 1 Halftones, color; 15 Halftones, black and white; 3 Illustrations, color; 234 Illustrations, black and white
Dimensions
Height: 254 mm
Width: 178 mm
ISBN-13
978-1-041-39060-2 (9781041390602)
Copyright in bibliographic data is held by Nielsen Book Services Limited or its licensors: all rights reserved.
Schweitzer Classification
Other editions
Additional editions
Book
approx. 06/2026
3rd Edition
CRC Press
€564.52
Not yet published
Person
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.
Content
Pharmaceutical Computer Systems Validation Volume 1
Foreword. Preface. About The Editor. Abbreviations. Chapter 1 Introduction. Chapter 2 Organization and Management. Chapter 3 Lifecycle Methodologies & Supporting Processes. Chapter 4 Prospective Verification and Validation. Chapter 5 Project Initiation and Compliance Determination. Chapter 6 Requirements Capture and Supplier (Vendor) Selection. Chapter 7 Design and Development. Chapter 8 Coding, Configuration, and Build. Chapter 9 Development Testing. Chapter 10 User Qualification and Authorization to Use. Chapter 11 Operation and Maintenance. Chapter 12 Phaseout and Withdrawal. Chapter 13 Data Integrity. Chapter 14 Regulated Electronic Records and Electronic Signatures. Chapter 15 Artificial Intelligence & Machine Learning. Chapter 16 Regulatory Inspections. Chapter 17 Compliance Strategies. Chapter 18 Capabilities, Measures, and Performance. Chapter 19 Practical Troubleshooting. Chapter 20 Concluding Remarks. Glossary. Index
Pharmaceutical Computer Systems Validation Volume 2
Foreword. Preface. List of Contributors. About The Editor. Abbreviations. Chapter 1: Case Study 1: Clinical Systems. Chapter 2: Case Study 2: Computerized Analytical Laboratory Systems. Chapter 3: Case Study 3: Chromatography Data Systems. Chapter 4: Case Study 4: Laboratory Information Management Systems. Chapter 5: Case Study 5: Process Instrumentation. Chapter 6: Case Study 6: Process Control Systems (Operational Technologies: OT). Chapter 7: Case Study 7: Process Analytical Technology. Chapter 8: Case Study 8: Manufacturing Execution Systems and Electronic Batch Records. Chapter 9: Case Study 9: Building Management Systems. Chapter 10: Case Study 10: Spreadsheets. Chapter 11: Case Study 11: Database Applications. Chapter 12: Case Study 12: Electronic Document Management Systems. Chapter 13: Case Study 13: Enterprise Resource Planning Systems. Chapter 14: Case Study 14: Marketing and Supply Applications. Chapter 15: Case Study 15: IT Infrastructure and Associated Services. Chapter 16: Case Study 16: Big Data Management. Chapter 17: Case Study 17: Web-based Applications. Chapter 18: Case Study 18: Blockchain. Chapter 19: Case Study 19: Mobile Devices. Chapter 20: Case Study 20: Medical Devices and Their Automated Manufacture. Chapter 21: Case Study 21: AI-enabled Computerized System. Chapter 22: Case Study 22: Blood Establishment Computer Systems. Glossary. Index
Foreword. Preface. About The Editor. Abbreviations. Chapter 1 Introduction. Chapter 2 Organization and Management. Chapter 3 Lifecycle Methodologies & Supporting Processes. Chapter 4 Prospective Verification and Validation. Chapter 5 Project Initiation and Compliance Determination. Chapter 6 Requirements Capture and Supplier (Vendor) Selection. Chapter 7 Design and Development. Chapter 8 Coding, Configuration, and Build. Chapter 9 Development Testing. Chapter 10 User Qualification and Authorization to Use. Chapter 11 Operation and Maintenance. Chapter 12 Phaseout and Withdrawal. Chapter 13 Data Integrity. Chapter 14 Regulated Electronic Records and Electronic Signatures. Chapter 15 Artificial Intelligence & Machine Learning. Chapter 16 Regulatory Inspections. Chapter 17 Compliance Strategies. Chapter 18 Capabilities, Measures, and Performance. Chapter 19 Practical Troubleshooting. Chapter 20 Concluding Remarks. Glossary. Index
Pharmaceutical Computer Systems Validation Volume 2
Foreword. Preface. List of Contributors. About The Editor. Abbreviations. Chapter 1: Case Study 1: Clinical Systems. Chapter 2: Case Study 2: Computerized Analytical Laboratory Systems. Chapter 3: Case Study 3: Chromatography Data Systems. Chapter 4: Case Study 4: Laboratory Information Management Systems. Chapter 5: Case Study 5: Process Instrumentation. Chapter 6: Case Study 6: Process Control Systems (Operational Technologies: OT). Chapter 7: Case Study 7: Process Analytical Technology. Chapter 8: Case Study 8: Manufacturing Execution Systems and Electronic Batch Records. Chapter 9: Case Study 9: Building Management Systems. Chapter 10: Case Study 10: Spreadsheets. Chapter 11: Case Study 11: Database Applications. Chapter 12: Case Study 12: Electronic Document Management Systems. Chapter 13: Case Study 13: Enterprise Resource Planning Systems. Chapter 14: Case Study 14: Marketing and Supply Applications. Chapter 15: Case Study 15: IT Infrastructure and Associated Services. Chapter 16: Case Study 16: Big Data Management. Chapter 17: Case Study 17: Web-based Applications. Chapter 18: Case Study 18: Blockchain. Chapter 19: Case Study 19: Mobile Devices. Chapter 20: Case Study 20: Medical Devices and Their Automated Manufacture. Chapter 21: Case Study 21: AI-enabled Computerized System. Chapter 22: Case Study 22: Blood Establishment Computer Systems. Glossary. Index