21 CFR 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
This
guide delineates the organization, planning, verification, and
documentation activities and procedural controls required for compliance
with FDA regulations related to international computer validation in
the pharmaceutical industry. The guide shows how to comply with computer
systems validation requirements, while highlighting and integrating
Part 11 requirements into the entire computer validation program.
Regulatory compliance is placed within the context of quality assurance,
and the importance of integrating validation into the system life cycle
using a structured top-down approach is stressed. Information is
applicable to computer systems for pharmaceuticals, cosmetics, food, and
medical device applications.
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