Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

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. Chapters cover areas including planning and implementation, standard operating procedures (SOPs) for validation, regulatory requirements and policies, design qualifications, and testing. Author information is not given. Annotation © 2004 Book News, Inc., Portland, OR