What is FDA 21 CFR Part 11?
FDA 21 CFR Part 11 refers to the regulations set forth by the FDA regarding electronic records and electronic signatures. The purpose of the regulation is to ensure that electronic records can be trusted in the same way that handwritten records and subsequent signatures on paper are trusted. Therefore, if you operate in the US. market within industries such as drug & medicine, food or tobacco industry, you need to follow FDA CFR part 11 regulations. You can read the full regulation here.
Does Eupry’s System Comply?
By purchasing Eupry’s FDA 21 CFR Part 11 Compliance Add-on, your system will comply with the regulations set by the FDA.
Our add-on package is designed to integrate seamlessly with our online temperature monitoring system, the Eupry Logger. In order to comply, there are some added features:
- Signing changes with an electronic signature. This can be your password or a configurable PIN code.
- Ability to export an audit log containing an exhaustive list of every change made within the system.
Find Out More
Eupry’s compliance add-on goes beyond just ensuring that you comply with the FDAs regulations, it also makes it easy to do so. Eupry are specialists in helping your organisation get FDA approval, therefore we are more than happy to discuss your individual requirements with you.
If you are interested, we highly recommend learning a bit more about the subject by reading this article, written by our Head of Quality. Beyond that, please do not hesitate to get in touch and talk with a member of our team who will be happy to answer any questions that you may have regarding FDA 21 CFR Part 11.