21 CFR 11.3 - Definitions.
(a) The definitions and interpretations of terms contained in section 201 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
(2)Agency means the
(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.
Title 21 published on 09-Nov-2018 03:23
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 11 after this date.
- 21 CFR 507.202 — General Requirements Applying to Records.
- 21 CFR 189.5 — Prohibited Cattle Materials.
- 21 CFR 112.165 — What Formats Are Acceptable for the Records I Keep?
- 21 CFR 117.305 — General Requirements Applying to Records.
- 21 CFR 1.512 — What FSVP May I Have if I Am a Very Small Importer or I Am Importing Certain Food From Certain Small Foreign Suppliers?
- 21 CFR 1.510 — How Must I Maintain Records of My FSVP?
- 21 CFR 101.8 — Vending Machines.
- 21 CFR 700.27 — Use of Prohibited Cattle Materials in Cosmetic Products.
- 21 CFR 101.11 — Nutrition Labeling of Standard Menu Items in Covered Establishments.
- 21 CFR 1.694 — Are Electronic Records Created Under This Subpart Subject to the Electronic Records Requirements of Part 11 of This Chapter?
- 21 CFR 1.329 — Do Other Statutory Provisions and Regulations Apply?
- 21 CFR 1.912 — What Record Retention and Other Records Requirements Apply to Shippers, Receivers, Loaders, and Carriers Engaged in Transportation Operations?
- 21 CFR 121.305 — General Requirements Applying to Records.