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The situation
A trial master file is assessed on whether the expected artefacts exist, are current, and are filed where they belong. Sponsors and sites both contribute, over years, under changing staff.
Inspection readiness is therefore a continuous reconciliation problem: comparing what the file contains against what the structure expects, repeatedly, across sites.
Why it is hard
Absence is hard to see
Reviewing a file shows what is there. Establishing what should be there and is not requires reading the file against an expected structure.
Misfiling looks like absence
A document filed in the wrong section is missing from the inspector's point of view, even though the organisation holds it.
Currency matters as much as presence
A superseded version filed as current is a finding, and it looks identical to a correct file until the versions are compared.
How we approach it
Agentix indexes the file, classifies each artefact against the expected structure, and reports presence, placement and currency as three separate questions with the document cited in each case.
Misfiled documents are reported as misfiled rather than missing, which turns a search into a move.
What changes
- Presence, placement and currency assessed separately
- Misfiling distinguished from genuine absence
- Superseded versions filed as current surfaced explicitly
- Runs in customer tenancy with QA sign off recorded
Next
Is this your problem too?
Bring the version of it you actually have. We will tell you what it would take, including when the answer is that it is not worth doing.