---
kind: "section"
citation: "21 C.F.R. § 11.200"
title: "21"
number: "11.200"
heading: "Electronic signature components and controls."
url: "https://uscodex.org/cfr/21/11.200"
---

# §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.

## Notes

### Authority

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.

### Source

Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.