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
Referenced in API Evangelist papers
This regulation shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this regulation in the context of a real sector.
The State of Biotechnology APIs
The most-named regulation in biotechnology at 23 of 999 companies. It mandates an immutable, attributable audit trail — and this market publishes the lowest governance score of any section measured, 28.8, so the trail exists inside the validated product and never reaches the interface.
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.
