Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.50
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 11 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 11 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A—General Part 11 Electronic Records; Electronic Signatures https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 — Unit 4.2.4 |
| Scope | G |
| Document part | § 11.50 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Electronic signature, Requirements, Electronic records |
| Comment | Electronic signature manifestation requirements |
Content
§ 11.50 Signature manifestations (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:
(1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).
