What a regulator inspection should feel like
Time-boxed access, a scoped view, and an access log the inspector can see too. No shared drives, no zip files.
The default inspection experience is a scramble: a folder of scans, a spreadsheet nobody trusts, and a week of reconstruction.
Grant access, do not ship files
An inspector needs a scoped, time-boxed view of the specific formulas and batches under review — not a copy of your entire quality system. A link that expires, covers a named scope and can be revoked mid-review is safer for both sides.
Log the review itself
Every record opened during an inspection should be logged, and the log should be visible to the inspector as well as the manufacturer. Symmetric visibility removes the argument about what was and was not disclosed.
Findings belong in the same system
A finding raised during fieldwork, the management response, the corrective action and the effectiveness check are one thread. Splitting that thread across email is how closure dates slip.
The test
Ask one question of your current setup: if an inspector arrived tomorrow and asked for the full history of a single batch, how long would it take? If the answer is measured in days, the problem is not diligence. It is architecture.