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.
21 CFR Part 11 · Electronic Records; Electronic Signatures
§ 11.70 Signature/record linking
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Warning letters citing § 11.70
1 FDA warning letters since 2017 cite this section :
- Nutreglo Products, LLC. 30 Oct 2018
FDA guidance that cites § 11.70
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers 1 Oct 2024
- Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors 15 Dec 2016
- Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry 5 Sept 2003
Amendment history
Federal Register documents that created or amended this section.
- 62 FR 13464 20 Mar 1997