Reference:USA 21 CFR Part 11 09-Apr-2025 § 11.200

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
Scope	G
Document part	§ 11.200
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
Comment	Electronic signature components and controls

Content

§ 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 identification code and password.
     (i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.
     (ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.
  (2) Be used only by their genuine owners; and
  (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.

(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.