§ 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).
How BatchGlow handles this
Each electronic signature is its own record: who signed, the date and time taken from the server, and the meaning of the signature (for example approval or release), bound to the one document it signs.
What it asks for, in plain words
- 21 CFR 11.50
- A signed electronic record shows the signer's printed name, the date and time of signing and what the signature means (such as review, approval, responsibility or authorship). These items are controlled like the record and appear in every readable form of it, on screen or printed.
These summaries are BatchGlow's reading of the text on this page, checked against it on 2 Oct 2026. The text governs.