An inspection should never be a scramble. A trial master file that is maintained continuously — rather than assembled at the end of the study — protects both the sponsor and the data.
1. File documents when they are created
Every week a document waits to be filed is a week in which it can be lost, misplaced or forgotten.
2. Track completeness against a plan
Use an expected-documents list tied to study milestones, so gaps are visible as soon as they appear.
3. Quality-check on a rolling basis
Sampling documents for correct naming, signatures and dating each month is far cheaper than a large clean-up before an audit.
4. Control access by role
Each user should see and change only what their role requires, with every action recorded in the audit trail.
5. Rehearse the inspection
Run a mock request for ten random documents. If they cannot be found in minutes, improve the process now.
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