21 CFR Part 11

Regulation United States · 1997

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.

Sectoral regime. It binds the industries below; companies outside them generally fall outside it.

Countries

Where this binds. Each links to the providers apis.io has catalogued there.

Regions

Industries

Each links to that industry as a scored cohort — so the question "how ready is this sector for the regime that governs it?" becomes one you can actually look at.

Implemented by these standards

A regulation is the law; a standard is the machine-readable contract that satisfies it. Almost every regime in this catalog restricts an interface rather than requiring one — where a standard exists, it is the part a provider can actually publish.