Learnaboutgmp Community

Fundamental question on document signatures

I’m having a philosophical discussion with our GCP QA Director on the signature dates on validation documents (URS, VMP, IQ protocol, etc). I say that the date a document is signed must be after the date of the document. He is says that all signatures must be obtained prior to the date of the document. Of course there’s no official reference to obtain this information and if we are audited someone will question it no matter what we do. Anyone care to comment?

Well, that depends on how the document is set up.The date that a document becomes ‘effective’ is usually the same as the last autherised persons signature date. A compiled date is when the document was actually compiled, ie before anyone has signed. The best is to have both, the date that the document was compiled and the date that the document becomes effective. This way you kill 2 birds with on stone.
:slight_smile: Hope that was of some help.

I agree it depends on how the document is set up. We have a system whereby the document author signs first (when they are happy with the document). This starts the approval process, which ends when the final approver has signed.

Hope that helps.

I’m not clear on what you mean by date of the document. Creation Date, Print Date, Approval date, effective date. The date of the document really is a secondary control (or primary if you wish) with the version number being the other. You could have one or the other, I am approving version 1.12 of the IQ or I am approving the IQ dated 12/12/08. Both mean the same thing and are traceable.

I think it refer to creation date, more over a document should have a revision history table which will display on what date it was originally created, initial version and reason and if there is any modification to the document then the revision history table should also be updated to display on what date it was modified , reason and document version.

Revision History
Author Date Version Reason
Abc 11/11/07 1.10 Initial version
Xyz 12/12/08 1.12 Revised for

Effective date is something related to SOPs etc and not qualifications. document signature dates are signoff dates / approval dates

I seem to disagree with “Effective date is something related to SOPs etc and not qualifications. document signature dates are signoff dates / approval dates” as a document is not effective until All protocol pre-approval signatures and dates have been completed. And a document that has not been approved cannot be executed. Therefore the document is not effective.

The best is to have both, the date that the document was compiled and the date that the document becomes effective. The easiest way to achieve this is by adding an explanation in your protocol stating that, “This document will only be effective/fit for execution once all protocol compilation review panel members have signed and dated in the relevant space allotted.” It is the same as with the completion of a protocol, " This protocol will only be accepted as being complete once All protocol exection review panel members have signed and dated in the allotted space provided"

Hope this is of some help.:slight_smile: