21 CFR Part 11

The Code of Federal Regulations (CFR) is a publication created by the departments and agencies of the Federal Government that is added to the Federal Register. These regulations represent the general and permanent rules and are revised yearly.

Title 21 of the CFR governs the rules for the Food and Drugs in the United States and is comprised of three parts, Chapters I-III. 21 CFR 11 is found under Chapter I, which is set by the  Food and Drug Administration and Department of Health and Human Services.


21 CFR Part 11 describes the requirements for electronic records and electronic signatures to meet the criteria of being considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. The rules apply to any electronic documents that are created, modified, maintained, archived, retrieved, or transmitted as required by the FDA. However, they do not apply to any paper documents that are transmitted via electronic means. While 21CFR Part 11 does not mandate the use of electronic systems, it provides guidance to those who wish to use them.


In order to ensure compliance, any computers, and associated hardware and software should be available for inspection by the FDA as needed.

Source: FDA Electronic Records; Electronic Signatures, 21 C.F.R. § 11 (1997).