21 CFR Part 11<p><strong>21 CFR Part 11</strong> defines FDA criteria for trustworthy electronic records and electronic signatures.</p> <p>It affects regulated documentation through audit trails, validation, electronic signatures, access controls, record retention, and procedural evidence.</p> <p><strong>Additional Resources</strong>:</p> <ul> <li><a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11" target="_blank" rel="noopener">Official / Authoritative Resource</a></li> </ul>