Document:USA 21 CFR Part 11 09-Apr-2025
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 âFood and Drugs
Chapter I âFood and Drug Administration, Department of Health and Human Services Subchapter AâGeneral 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
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.3 (b) (6) | G | § 11.3
(b) (6) || EN || § 11.3 Definitions [âŚ] (b) The following definitions of terms also apply to this part: [âŚ] (6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information ... | ||
| Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.10 | G | § 11.10 | EN | Subpart BâElectronic Records § 11.10 Controls for closed systems. Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls ... |
| Reference: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 and controls designed to ensure the authenticity, ... |
| Reference: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 [âŚ] (b) The following definitions of terms also apply to this part: [âŚ] (5) Digital signature means an electronic signature based upon cryptographic methods of originator ... | ||
| Reference: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 following: (1) The printed name of the signer; ... |
| Reference: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 electronic records to ensure that the signatures ... |
| Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.100 | G | § 11.100 | EN | Subpart CâElectronic Signatures § 11.100 General requirements (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. (b) Before an ... |
| Reference: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 distinct identification components such as an ... |
| Reference: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 passwords shall employ controls to ensure their ... |
