Extrusion System (Liposome Extruder) – 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 extrusion system maintains specified pressure during operation. H DQ-001 IQ-001 OQ-001 PQ-001 Pressure logs Pass/Fail
URS-002 Verify membrane pore size meets specifications for liposome production. M DQ-002 IQ-002 OQ-002 PQ-002 Pore size analysis report Pass/Fail
URS-003 Monitor temperature during the extrusion process to ensure optimal conditions. H DQ-003 IQ-003 OQ-003 PQ-003 Temperature records Pass/Fail
URS-004 Confirm flow rate is within defined parameters throughout the operation. M DQ-004 IQ-004 OQ-004 PQ-004 Flow rate measurements Pass/Fail
URS-005 Document all operational records for validation purposes. L DQ-005 IQ-005 OQ-005 PQ-005 Validation records Pass/Fail
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