Articles in this section

Is Factbird CFR-21 Part 11 compliant?

Factbird logs all create/update/delete events. Audit logs may be requested through Factbird support and are priced per time used per audit request. Audit logs are stored for 3 years as default and are customizable for enterprise customers. To answer the question specifically, we do not adhere to this regulation.

Has anyone used Factbird in GxP environment?

Yes, numerous customers use Factbird for pharmaceutical manufacturing or medical devices. We know Factbird is often used to support deviations and other GxP procedures. You can find reference cases on our website here: https://www.factbird.com/industries/pharmaceutical

 

21 CFR Part 11 compliance refers to the regulations set by the U.S. Food and Drug Administration (FDA) for electronic records and electronic signatures used in industries regulated by the FDA, such as pharmaceuticals, medical devices, and biotechnology. It ensures that electronic records and signatures are trustworthy, reliable, and equivalent to paper-based records and handwritten signatures. 

 

Was this article helpful?
0 out of 0 found this helpful