Source: https://www.temperaturemonitoringuae.com/21-cfr-part-11/
Timestamp: 2017-07-27 08:49:22
Document Index: 721547213

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

What is 21 CFR Part 11 for LifeScience & Pharma industry |
Home › Cold Chain validation › What is 21 CFR Part 11?
Posted on June 20, 2014 by Vacker
No Comments ↓	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).
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/
‹ Infrared (IR) / Laser Thermometer
How to select Data logger? ›
Posted in Cold Chain validation	Tagged with: 21 CFR Part 11, 21 CFR Part 11 for Pharmaceuticals, Validation against 21 CFR Part 11	Leave a Reply Cancel reply