Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1st Books Library) - Softcover

Goldman, Stephen Robert

 
9781410737441: Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry (1st Books Library)

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

"synopsis" may belong to another edition of this title.

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, responsibilities, and requirements of system validation. Ch

"About this title" may belong to another edition of this title.