What is 21 CFR Part 11?

21 CFR Part 11 also is generally known as CFR Part 11. The entire description is part 11 of Title 21 of the Code of Federal

Regulations (CFR); Electronic Records; Electronic Signatures

CFR Part 11 is the name of an American Regulation by the FDA. It is a reference that is not only used in US but worldwide (even though some equivalent ones could exist in several countries).

Brief Explanation of 21 CFR Part 11

When you are using an electronic recorder consisting of various hardware and software, the data is converted and transmitted through various means. During this whole process, the entire data processing has to be validated to make sure that there is no data corruption in the entire process. This is ensured by compliance to 21 CFR Part 11.

CFR Part 11 is essentially about electronic signature, and how to ensure that data generated by a software and/or electronic device, have not been voluntarily/involuntarily altered/modified by someone. It details several points that a company must implement before stating its solution is CFR Part 11 such as: generating a PDF file that cannot be modified, certify that data are encrypted, software must have an ID and password to login, audit trail and be validated…etc.

This standard is usually known and requested in the life science industry. If you want to rely on loggers to certify that pharmaceutical products are correctly maintained within their proper range of temperature, you have to make sure that data generated are reliable.

The purpose of 21 CFR part 11 is basically to ensure that the data read and stored by a software and electronic instruments are entirely accurate.

The entire standard is public and available at :

Read here 21 CFR Part 11