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

Title 21Chapter ISubchapter APart 11Subpart B → §11.50


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


§11.50   Signature manifestations.

(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following:

(1) The printed name of the signer;

(2) The date and time when the signature was executed; and

(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature.

(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout).

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