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

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification pri

This book presents the topic of computer systems validation in a regulated environment in a manner that the layman can understand. It explains the relationship

This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutic