If you maintain records or submit information to the Food and Drug Administration (FDA) electronically, you need to comply with 21 CFR Part 11.
If you are not aware of FDA’s regulation, this article will tell you all you need to know about it, why it’s important for you and the best way to implement it in your organization.
We’ll also tell you briefly about how our 21 CFR Part 11 compliant solution stack makes it super easy for you to not only adhere to the FDA regulations but also benefit greatly from it.
What is 21 CFR Part 11?
In August 1997, FDA issued a set of regulations that enlist its acceptance criteria for all forms of electronic data.
This set of regulations was issued as Part 11 of Title 21 of FDA’s Code of Federal Regulations, simply known as 21 CFR Part 11. It applies to all electronic records that are created, modified, maintained, archived, retrieved, or transmitted. It also gives us guidelines for setting up an FDA compliant, digital Quality Management System, where digital records and signatures are used in place of traditional methods.
The recommendations under 21 CFR Part 11 are in line with Pharmaceutical Good Manufacturing Practice (GMP).
