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== == Maybe you mean 21 CFR Part 11?
Requirements for electronic signatures and electronic record systems used by FDA and related suppliers or distributors.
See http://www.21cfrpart11.com/
Wiki User
∙ 16y ago
21 CFR Part 11 is a regulation issued by the FDA that defines the criteria under which electronic records and electronic signatures are considered reliable and equivalent to paper records and handwritten signatures. It applies to electronic records created, maintained, and/or submitted to the FDA in support of regulatory compliance.
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-21
