Computer System Validation:Insight in Global Pharmaceutical Regulation Marmik V. Chaudhari, Keyur N. Patel and Bhuvan P. Raval

Computer System Validation is a mandatory requirement as per various regulatory authorities. Major ones are USFDA, EMEA, Swissmedic and Health canada. This book is based on generally recognized software validation principles and, therefore, can be applied to any software. This guidance applies to any software related to a regulated medical device, It does not specifically identify which software is or is not regulated. Это и многое другое вы найдете в книге Computer System Validation:Insight in Global Pharmaceutical Regulation (Marmik V. Chaudhari,Keyur N. Patel and Bhuvan P. Raval)