If a paper document is scanned for filing into an eTMF, we understand that the resulting digital document should be compared against the original paper document, to ensure it is a copy with the same meaning and content as the original.

Should the comparison process be recorded for each document, and if so, should those records be stored in the eTMF?

Or, is it sufficient to have a SOP or per-study manual which describes the process?

I have read FAQ #12.

Thank you.