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).qualification of cold storage

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 : 21 CFR Part 11 view or download

Please see more about Qualification & Validation of Cold rooms, warehouse, vans etc at http://www.temperaturemonitoringuae.com/services/temperature-mapping-validation/cold-chain-temperature-mapping/

Posted in Cold Chain validation Tagged with: , ,

Leave a Reply

Your email address will not be published. Required fields are marked *

*



Choose our products and services