Computer Systems Validation is the most comprehensive guide to computer validation currently available. This invaluable reference discusses good laboratory, clinical, manufacturing, and distribution practices and explains the latest regulatory developments for the US FDA and other regulatory authorities. Practical examples and checklists appear throughout the book, together with an exploration of the role of quality assurance and risk management as key components of pragmatic regulatory compliance. It reviews over twenty case studies from renowned industry experts who examine different types...
Computer Systems Validation is the most comprehensive guide to computer validation currently available. This invaluable reference discusses good labor...
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical info...
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP...
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and ver...
