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No Audit Trail Review → Only Passing Events Printed
Selective Data Capture in Manufacturing
Operators not recording/printing negative filter integrity tests; only "pass" evidence was retained. Lack of electronic raw data and audit trail review by Production/QA.
Where This Issue Shows Up
Manufacturing execution records, equipment logs, utility monitoring, filter integrity tests, environmental monitoring.
What Had Happened
- 1
Inspectors observed operators not recording/printing negative filter integrity tests; only "pass" evidence was retained.
- 2
FDA criticized lack of electronic raw data + audit trail review by Production/QA.
- 3
Firm promised audit trail review but response lacked scope/time-period and CAPA specifics.
Why It Matters
It's a classic "selective data capture" + failure to review audit trails → regulators interpret as potential falsification.
Bad Consequences
Batch impact assessment, potential batch disposition challenges, and credibility damage with regulators.
Our Mitigation Strategy
What "audit-ready software" must enable:
1Technical Controls
System design: auto-capture of all test outcomes (pass/fail) with no operator "print-to-prove" loophole.
"Batch review cockpit": QA can review exceptions + audit trail deltas (changes, repeats, aborted events).
2Procedural Controls
CAPA must include retrospective review scope + periodic governance.
Category
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