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

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedur

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