---
kind: "section"
citation: "21 C.F.R. § 11.3"
title: "21"
number: "11.3"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/11.3"
---

# §11.3. Definitions.

- (a) The definitions and interpretations of terms contained in [section 201](/cfr/21/201.md) of the act apply to those terms when used in this part.
- (b) **The following definitions of terms also apply to this part—**
  - (1) Act means the Federal Food, Drug, and Cosmetic Act ([secs. 201-903](/cfr/21/201-903.md) ([21 U.S.C. 321-393](/usc/21/321-393.md))).
  - (2) Agency means the Food and Drug Administration.
  - (3) Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.
  - (4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
  - (5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.
  - (6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.
  - (7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
  - (8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
  - (9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

## 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.