Aseptic Filling Machine (IV Bottles) – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result
URS-001 Ensure fill volume accuracy within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Volume Calibration Report Pass/Fail
URS-002 Verify proper stopper/cap placement on each bottle. M DQ-002 IQ-002 OQ-002 PQ-002 Placement Verification Log Pass/Fail
URS-003 Implement reject audit trail for non-compliant bottles. L DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Report Pass/Fail
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