About Title 21 CFR Part 11 FDA compliant signatures.
Title 21 CFR Part 11 covers electronic records, specifically electronic signatures. Learn what you need to know to be compliant with FDA signature requirements.
Electronic signatures, sometimes called e-signatures, are legal to get consent or approval on electronic documents or forms. You can use e-signatures to replace handwritten signatures in practically every application. This includes digital signatures for government records that require stricter authentication.
What to know about Title 21 CFR Part 11 signatures.
The Code of Federal Regulations (CFR) spells out the general and permanent rules and regulations published by the executive departments and agencies of the United States federal government. The broad areas subjected to federal regulation are divided into 50 titles. Title 21 covers food and drugs for the Food and Drug Administration (FDA). Part 11 of this title covers electronic records and electronic signatures.
The information contained in title 21 CFR part 11 is extensive and leads to other federal regulations, but here are a few of the key provisions in this important regulation:
- Part 11 describes the circumstances for when the FDA considers electronic signatures to be trustworthy, reliable, and equivalent to handwritten signatures executed on paper.
- T Part 11 subpart A, general provisions, lists the types of records to which the provisions of electronic signatures apply.
- Part 11 also lists the types of records that aren’t governed by this part of the regulation.
- Subpart C, electronic signatures, covers the components and controls required by part 11.
Your choice of e-signature tool should help you meet title 21 CFR part 11 requirements. Discover what more you can do with Adobe Sign to keep signatures safe and secure.