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21 CFR Part 11 is the FDA's regulation for electronic documentation and electronic signatures. It outlines the administration of electronic records in a medical device company's quality management system and gives guidance for industry best practices.

Let's go through these four requirements now. Intention to sign. It sounds obvious, but an eSignature will only be deemed valid if the signatory had the intention to sign it. ... Consent to doing business electronically. ... Association of the signature with the record. ... Record retention.

When a signer electronically signs a document, the signature is created using the signer's private key, which is always securely kept by the signer. The mathematical algorithm acts like a cipher, creating data matching the signed document, called a hash, and encrypting that data.

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, and/or transmitted under any records requirement set forth by the FDA.

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

CFR stands for ?Code of Federal Regulation.? 21 CFR Part 11, in particular, details the criteria under which electronic records and signatures are considered to be trustworthy and equivalent to paper records.