Automated Visual Inspection Machine – 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 The equipment shall accurately inspect syringes and cartridges for defects. H DQ-001 IQ-001 OQ-001 PQ-001 Inspection Report Pass
URS-002 The equipment shall implement reject logic for defective products. H DQ-002 IQ-002 OQ-002 PQ-002 Reject Logic Validation Report Pass
URS-003 The equipment shall maintain an audit trail of inspection results. M DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Log Pass
URS-004 The inspection accuracy shall meet predefined criteria. H DQ-004 IQ-004 OQ-004 PQ-004 Accuracy Test Report Pass
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