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I'm curious about something regarding electronic signatures and OpenClinica.. When I read the part 11 document I thought I needed to record the actual signing and include certain data points (we have had different QA consultants expect different things in this regards so maybe its not a standard practice).. anyway I'll paste the part 11 doc I'm referring to below.. b ut basically when I see that I read that I need to record the name, datetime, and meaning.. I don't see this anywhere in OC.. am I missing it????
PART 11 -- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart B--Electronic Records
Sec. 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).