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

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

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

The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and intern