Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry - Couverture souple

Goldman, Stephen Robert

 
9781410737441: Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Synopsis

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsib

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