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Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

FDA Signature Options The printed name of the signer. The date and time the signature was executed. A unique user ID. The “digital adopted signature”, which can be any one of the following: The signer's name and initials reproduced in an electronic “font” ... The meaning of the signature (known as the “signing reason”)

In law, non-repudiation is a situation where a statement's author cannot successfully dispute its authorship or the validity of an associated contract. The term is often seen in a legal setting when the authenticity of a signature is being challenged.

The FDA's regulations related to electronic records and electronic signatures (21 CFR Part 11) is intended to: Allow the use of electronic documents and signatures in the regulatory process for drugs and devices. An academic medical center is selecting a new database system for clinical research.

1 A non-repudiation agreement allows the FDA to receive electronically signed submissions in compliance with 21 CFR Part 11.100. 5.1. 2 A letter of non-repudiation must be submitted to the FDA for each individual registering for an FDA ESG account. An example of a letter of non-repudiation is included in Attachment 1.

Nonrepudiation means a user cannot deny (repudiate) having performed a transaction. It combines authentication and integrity: nonrepudiation authenticates the identity of a user who performs a transaction and ensures the integrity of that transaction.

Repudiation occurs when one party decided to terminate a contract made with another party by letting them know they cannot (for whatever reason) honor the contract agreement.

Accepted signature methods by FDA are: Scanned signatures. Digital signatures. Flattened digital signatures. A flattened digital signature must include (see example): the printed name of the signer. the date and time when the signature was executed. the reason for signature.

Utilize digital signatures Utilizing digital signatures is crucial for enforcing non-repudiation, as they serve as a cryptographic proof of the origin and integrity of electronic documents and messages.