Title 21 CFR Part 11
A Title 21 CFR Part 11 is a Title 21 of The Code of Federal Regulations that establish the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records.
- Context:
- It can provide Regulatory compliance information regarding the U.S. Food and Drug Administration's (FDA) guidelines on electronic records and electronic signatures.
- ...
- See: Electronic Signature, Title 21 of The Code of Federal Regulations, Code of Federal Regulations, Food And Drug Administration (United States).
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Title_21_CFR_Part_11 Retrieved:2022-10-19.
- Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
2022
- https://www.limswiki.org/index.php/21_CFR_Part_11
- QUOTE: ... The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding the U.S. Food and Drug Administration's (FDA) guidelines on electronic records and electronic signatures. Within this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to ensure electronic signatures are as legally binding as hand-written signatures.[1]
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech and biologics companies, contract research organizations, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for closed and open software and systems involved in processing specific electronic data. This primarily includes data to be maintained by the FDA predicate rules and data used to demonstrate compliance to a predicate rule. (A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.[2]) The rule also applies to submissions made to the FDA in electronic format, but not to paper submissions by electronic methods, though paper submissions may eventually be prohibited by the FDA.[3] ...
- QUOTE: ... The Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) provides compliance information regarding the U.S. Food and Drug Administration's (FDA) guidelines on electronic records and electronic signatures. Within this part, requirements are created to help ensure security, integrity, and confidentially of electronic records and to ensure electronic signatures are as legally binding as hand-written signatures.[1]
- ↑ "Electronic Code of Federal Regulations - Title 21: Food and Drugs - Part 11: Electronic Records; Electronic Signatures". U.S. Government Printing Office. 13 April 2020. https://www.ecfr.gov/current/title-21/part-11. Retrieved 07 January 2022.
- ↑ "Part 11, Electronic Records; Electronic Signatures — Scope and Application". U.S. Food and Drug Administration. August 2003. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application. Retrieved 15 April 2020.
- ↑ Huber, L. (15 November 2012). "Tutorial: 21 CFR Part 11 - Electronic Records and Electronic Signatures". LabCompliance. Archived from the original on 03 January 2020. https://web.archive.org/web/20180103191244/http://www.labcompliance.com/tutorial/part11/. Retrieved 15 April 2020.