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 of computer systems.
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