Signature Manifestation - 11​.50

21 CFR Part 11:

“(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).”

As discussed previously, (see Figure 14 and Figure 15) when a signature is requested, the “Action” context relative to the signature is displayed. This action reflects the function name which is recorded along with the user_id, user name, date time and signature level (“Done By”/”Check By”). This is displayed in Figure 33.

Figure 33 - Audit_Event table with User_Id information