21 cfr part 11 an FDA compliance guideline

An FDA compliance guideline, 21 CFR part 11 specifies the standards for evaluating the trustworthiness of electronic documents and electronic signatures.

The FDA regulation known as 21 CFR Part 11 outlines the standards under which electronic records and electronic signatures are deemed trustworthy, reliable, and equal to paper records. The FDA-regulated companies that opt to maintain their primary, authoritative documents online are subject to Part 11, as it is often called, which was adopted in 1997. It lays down the standards and regulations for copying, access, permissions, audit logs, and tracking. Version control for the electronic records is also mentioned, as well as applying electronic signatures to them.