21 C.F.R. § 11.30 Controls for open systems.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart B—Electronic Records
§ 11.30 Controls for open systems.
