Rövid leírás:

Computerized systems play a fundamental role in the development, manufacture, and supply of medical treatments. This set collects both Volumes 1 and 2 of the third edition of the best‑selling book dealing with validation and compliance of computer systems and software in the pharmaceutical, healthcare, and medical device industries.

Hosszú leírás:

Pharmaceutical Computer Systems Validation Volume 1

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.

Pharmaceutical Computer Systems Validation Volume 2

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 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

Tartalomjegyzék:

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