Ointment Tube Filling Machine (Sterile/Controlled) – 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 Machine must accurately fill ointment into ophthalmic tubes. H DQ-001 IQ-001 OQ-001 PQ-001 Filling Accuracy Report Pass/Fail
URS-002 Sealing integrity must ensure no leakage of ointment. H DQ-002 IQ-002 OQ-002 PQ-002 Sealing Integrity Test Report Pass/Fail
URS-003 Reject audit trail must be maintained for all production runs. M DQ-003 IQ-003 OQ-003 PQ-003 Audit Trail Log Pass/Fail
URS-004 Fill weight must be within specified limits. H DQ-004 IQ-004 OQ-004 PQ-004 Fill Weight Verification Report Pass/Fail
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