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e-CFR data is current as of October 26, 2020

Title 21Chapter ISubchapter APart 11Subpart B → §11.30


Title 21: Food and Drugs
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart B—Electronic Records


§11.30   Controls for open systems.

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.

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