Tangential Flow Filtration (TFF) System – 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 TMP is maintained within specified limits during operation. H DQ-001 IQ-001 OQ-001 PQ-001 TMP Log [Pass/Fail]
URS-002 Verify flow rates meet operational requirements. M DQ-002 IQ-002 OQ-002 PQ-002 Flow Rate Record [Pass/Fail]
URS-003 Confirm membrane integrity before and after use. H DQ-003 IQ-003 OQ-003 PQ-003 Membrane Integrity Test Report [Pass/Fail]
URS-004 Ensure temperature remains within specified limits during operation. M DQ-004 IQ-004 OQ-004 PQ-004 Temperature Log [Pass/Fail]
URS-005 Audit trail must be maintained for all critical parameters. L DQ-005 IQ-005 OQ-005 PQ-005 Audit Trail Record [Pass/Fail]
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