21 CFR Part 11 Introduction:
21 CFR Part 11, the Food and Drug Administration( FDA) instals its requirements for electronic records and signatures. These regulations, which apply to all FDA program arenas, were intended to permit the widest possible use of electronic engineering, compatible with FDA’s responsibility to protect the public health.
The DocuSign Agreement Cloud is used by pharmaceutical and medical machine companies to meet a range of compliance requirements, including those set forth in the Code of Federal Regulations Title 21 Part 11.
We have a complete guide to CFR Part 11 and electronic signatures with examples of how DocuSign solutions satisfy requirements.
Here we’ll summarize subpart C of CFR Title 21 Part 11, which synopsis requirements related to the use of electronic signatures.
What is 21 CFR Part 11?
The part of Title 21 of the Code of Federal Regulations that establishes the United Country Food and Drug Administration regulations on electronic records and electronic signatures.
The term” Part 11″ applies to records in electronic form that are created, modified, maintained, archived, retrieved, channelled or submitted, under any records requirements set forth by the FDA regulations/ predicate rules.
Life science organizations and device manufacturers regulated by the FDA are required to follow the Code of Federal Regulations Title 21 Part 11.
The FDA also issued a guidance newspaper” Part 11, Electronic Records; Electronic Signatures — Scope and Application” to provide clarifications on electronic records and electronic signatures.
What does 21 CFR Part 11 involve related to electronic signatures?
The FDA permits electronic signatures to be used in place of pen and ink signatures on paper documents so that business can be conducted digitally. In degree to be compliant electronic signatures must include:
The etched call of the signer
The appointment and duration the signature was executed
A unique user ID
Digital adopted signature
The sense of the signature( labeled” ratifying intellect “)