Kaplan Eduneering: Complying with 21 CFR Part 11: Electronic Records and Signatures

Complying with 21 CFR Part 11: Electronic Records and Signatures

In 1997, the Food and Drug Administration (FDA) issued the final rule on the criteria under which electronic signatures and records will be accepted in lieu of handwritten signatures and records executed on paper.

The scope of this regulation, 21 CFR Part 11, has far reaching implications for all businesses in the pharmaceutical, biotech, medical device, health care, and food industries. According to the rule, “this Part (21 CFR Part 11) applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted.

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Complying with 21 CFR Part 11: Electronic Records and Signatures

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