The 21 CFR guidelines in pharma is the 21 CFR Part 11 which is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures.
The 21 CFR regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.
The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contain the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Title 21 CFR Part 11 helps life sciences companies establish security controls, workflows, audit trails, and checks to ensure the integrity, confidentiality, and authenticity of electronic records and signatures.
FDA regulations can be found in Title 21 of the Code of Federal Regulations (CFR).
FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance.
FDA guidance describes the agency's current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA.
The full text of the Federal Register and the Code of Federal Regulations (CFR) are on GPO's website.
For the Federal Register, you can perform fielded searches from 1995 to the present, and browse entire issues since 1994.
Editions of CFR titles are online for 1996 to the present.