The integrity of the audit trail is the backbone of a validated data capture system since it records all changes to data, including who made the initial entry and when in addition to when, why and by whom any subsequent changes to data were made.

That being said, is it ever acceptable to modify an audit trail?

The question arises since I have seen this occur in an electronic data capture system and the justification provided for this action was that the edits made to the audit trail were also captured and so the practice was deemed acceptable, and indeed "defensible" in a regulatory inspection.

Personally, I think this unacceptable, but I would be interested to hear others' opinions, especially those from the Inspectorate.