Sterile Filtration Skid (if feasible) – 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 the filtration skid maintains sterility throughout the process. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass
URS-002 Verify that the flow rate meets specified criteria. M DQ-002 IQ-002 OQ-002 PQ-002 Flow Rate Test Record Pass
URS-003 Confirm that the differential pressure (DP) is monitored and logged. H DQ-003 IQ-003 OQ-003 PQ-003 DP Monitoring Log Pass
URS-004 Ensure an integrity test is performed on the filtration membrane. H DQ-004 IQ-004 OQ-004 PQ-004 Integrity Test Report Pass
URS-005 Document an audit trail for all critical parameters. M DQ-005 IQ-005 OQ-005 PQ-005 Audit Trail Log Pass
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