21 CFR: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry, Part 11
Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.
What people are saying - Write a review
We haven't found any reviews in the usual places.
Other editions - View all
21 CFR Part 11: Complete Guide to International Computer Validation ..., Part 11
No preview available - 2004