Title 21 CFR Part 11: What are FDA compliant signatures?
Learn about part 11 of Title 21 CFR and how it changes electronic record and signature regulations on government documents.
What is 21 CFR Part 11?
The Code of Federal Regulations (CFR) are rules that the executive departments of the U.S. Federal Government must follow. Title 21 contains all regulations that apply to the Food and Drug Administration (FDA), while Part 11 pertains to criteria that make electronic signatures and documents trustworthy for use in the Federal Government.
Essentially, all electronic documents or signatures used by the FDA must follow the rules covered in Title 21 CFR Part 11. If electronic government documents adhere to all regulations under Part 11, they become the equivalent of paper records.
The FDA oversees highly technical and complicated industries that require immense amounts of paperwork. Any time a corporation needs to implement controls, request an audit, or document new systems, they must submit paperwork to the FDA.
Title 21 CFR Part 11 brings FDA regulations into the digital age by allowing electronic documents and signatures on official government business. This affects industries regulated by the FDA, including:
- Drug manufacturers
- Medical device producers
- Biological developers
The use of digital signatures and electronic documents helps to speed up processes and simplify the approval of new products.
To be accepted under 21 CFR Part 11, a digital document and e-signature must be secure, trustworthy, and reliable. Use trusted software like Acrobat Sign to legally sign digital documents with the click of a button and move along government processes.