is the gap analysis document is auditable by the auditor? as there may be gaps in the system between the regulatory requirement and actual present which asper the auditor is a NC
One can argue Gap Analysis = Self Inspection. In which case, YES, we would have access to the document.
If a seperate self inspection exists, then I would probably never ask for a gap analysis. It might as well be considered a internal document only.
Morphius909 - who is the ‘we’ in your statement?
Not sure if this is a FDA related question, but if Gap Analysis = Self Inspection = internal audit, then per 820.180©, the audit reports are not subject to review.
Not sure what the case would be for an ISO audit.