Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in § 11.10 , as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality.
21 CFR Part 11 · Electronic Records; Electronic Signatures
§ 11.30 Controls for open systems
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 11.30
- Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff 3 Feb 2026
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers 1 Oct 2024
- Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors 15 Dec 2016
- Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry 5 Sept 2003
Amendment history
Federal Register documents that created or amended this section.
- 62 FR 13464 20 Mar 1997