21 CFR Part 11 is the FDA rule setting the conditions under which electronic records and electronic signatures are treated as equivalent to paper and ink. It requires validated systems, secure computer-generated time-stamped audit trails that record who changed what and when without obscuring the prior value, operational and authority checks, and the ability to produce accurate copies for inspection. Any API writing to a record that supports an FDA submission inherits these obligations.
21 CFR Part 11
Statute United States
Implemented by these standards
A regulation is the law; a standard is the machine-readable contract that makes it real. These are the technical standards that implement this regulation, catalogued at standards.apievangelist.com.
CDISC
The submission datasets whose electronic records Part 11 governs.
