Re: Possible to have a completely electronic archival system that meets FDA requireme
My employer has been told by US FDA in the past that FDA does not accept a scan of a signature as valid. A signature must be either physical-original, or electronic-original and applied via a validated system. A signature that's applied via a reproduction, copying or editing method is never valid.
They told us it's permissible for a second person who has physically seen that the physical signature on the original document was present and not tampered with, forged, etc., to sign in a validated electronic manner the scanned copy as to the validity of the original (first person's) signature. Then a scan of a non-retained physically signed paper original becomes valid.
That however is a difficult process to implement other than by buying an engineered, validated system that implements that process. It can't be done just with a scanner.
