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21 CFR Part 11 (FDA) - DIY Assessment

21 CFR Part 11 is a regulation issued by the US Food and Drug Administration (FDA) that establishes requirements for electronic records and signatures in the context of FDA-regulated activities. It applies to pharmaceutical, biotech, and medical device companies that use electronic records and signatures in their operations.

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21 CFR Part 11 (FDA) - DIY Assessment $2499.00