Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its im
Lopez describes good electronic records integrity practices relevant to the Worldwide Health Agency Good Manufacturing Practices. Based on risk assessment principles, he provides practical informat
This book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the Annex 11 guidelines into the computer validation prog
