Ophthalmic Filling Machine (Dropper 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 The equipment must accurately fill dropper bottles to the specified volume. H DQ-001 IQ-001 OQ-001 PQ-001 Filling Accuracy Report
URS-002 The equipment must have a reject logic system to handle out-of-spec fill volumes. M DQ-002 IQ-002 OQ-002 PQ-002 Reject Logic Test Report
URS-003 The equipment must maintain an audit trail for all filling operations. H DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Log
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