We have just implemented a new tool (Oracle Agile) which allows for electronic signature sign off of documents within the application workflow.
However when we print the documents, the signature does not appear on the document.
Instead we are considering putting the following generic statement on each document:
[FONT="]All approvals are maintained in the Document Control System. Refer to the Document Control System for the current controlled revision and approval records. Draft, archived, and obsolete revisions are not to be used. Access the Document Control system to verify revision.[/FONT]
Question: Must a replica of the electronic signature appear on the document itself once printed for use at point of use or does this statement satisfactorily replace the physical electronic signature and keep us in compliance with Annex 11 and 21CFR11.
However when we print the documents, the signature does not appear on the document.
Instead we are considering putting the following generic statement on each document:
[FONT="]All approvals are maintained in the Document Control System. Refer to the Document Control System for the current controlled revision and approval records. Draft, archived, and obsolete revisions are not to be used. Access the Document Control system to verify revision.[/FONT]
Question: Must a replica of the electronic signature appear on the document itself once printed for use at point of use or does this statement satisfactorily replace the physical electronic signature and keep us in compliance with Annex 11 and 21CFR11.
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