Document:USA 21 CFR Part 11 09-Apr-2025

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

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 […] (b) The following definitions of terms also apply to this part: […] (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 B—Electronic 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 […] (b) The following definitions of terms also apply to this part: […] (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 C—Electronic 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 ...