If a 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 (QC) process also be documented, and if so, should those records also be stored in the eTMF?

Or, would it be sufficient to document the process, for example in a study-specific manual?

I have read the FAQ section but still seek clarification on this matter.

Thank you.