Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Stephen Robert Goldman
Broschiertes Buch

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

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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