Document:USA 21 CFR Part 11 09-Apr-2025
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| 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 | |
References
| Scope | Document part | Language | Preview | |
|---|---|---|---|---|
| USA 21 CFR Part 11 09-Apr-2025 § 11.10 | G | § 11.10 | EN | Subpart B—Electronic Records
§ 11.10 Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic r… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.100 | G | § 11.100 | EN | Subpart C—Electronic Signatures
§ 11.100 General requirements (a) Each electronic signature shall be unique to one individual and shall not be reused … |
| USA 21 CFR Part 11 09-Apr-2025 § 11.200 | G | § 11.200 | EN | § 11.200 Electronic signature components and controls
(a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two d… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (5) ; (b) (7) ; (b) (8) | G | § 11.3 (b) (5) ; (b) (7) ; (b) (8) | EN | § 11.3 Definitions
[…] (b) The following definitions of terms also apply to this part: […] (5) Digital signature means an electronic signature based u… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) | G | § 11.3 (b) (6) | EN | § 11.3 Definitions
[…] (b) The following definitions of terms also apply to this part: […] (6) Electronic record means any combination of text, graphi… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.30 | G | § 11.30 | EN | § 11.30 Controls for open systems. Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures an… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.300 | G | § 11.300 | EN | § 11.300 Controls for identification codes/passwords. Persons who use electronic signatures based upon use of identification codes in combination with… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.50 | G | § 11.50 | EN | § 11.50 Signature manifestations (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the… |
| USA 21 CFR Part 11 09-Apr-2025 § 11.70 | G | § 11.70 | EN | § 11.70 Signature/record linking. Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective … |
