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
System Assurances: Modeling and Management updates on system assurance and performance methods using advanced analytics and understanding of software reliabilit
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pha