21 CFR 11.30
§ 11.30 Controls for open systems.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 11.30, § 11.30 Controls for open systems, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83086
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.