FDA CFR

What is the FDA CFR ?

The Code of Federal Regulations (CFR) contains the rules and regulations for executive departments and agencies of the US federal government. Each of the 50 titles of the CFR addresses a different regulated area. 

FDA CFR Title 21 regulates food and drugs manufactured or consumed in the United States, under the jurisdiction of the Food and Drug Administration (FDA), the Drug Enforcement Administration, and the Office of National Drug Control Policy. The regulations outlined in CFR Title 21 Part 11 set the ground rules for the technology systems that manage information used by organizations subject to FDA oversight. 

CFR Title 21 Part 11 sets requirements to ensure that electronic records and signatures are trustworthy, reliable, and equivalent substitutes for paper records and handwritten signatures. Subject companies must prove that their processes and products work as they are designed to, and if these process and products change, they must revalidate that proof. 

This solution will provide your organisation guidance on how to gain and maintain compliance with the FDA CFR.