Distillation Unit / Distillation Column – 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 distillation unit operates within specified temperature ranges. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs Pass/Fail
URS-002 Verify that pressure control is maintained within acceptable limits. H DQ-002 IQ-002 OQ-002 PQ-002 Pressure logs Pass/Fail
URS-003 Confirm the reflux ratio is adjustable and monitored accurately. M DQ-003 IQ-003 OQ-003 PQ-003 Reflux ratio logs Pass/Fail
URS-004 Ensure PLC audit trail logs are generated and maintained. M DQ-004 IQ-004 OQ-004 PQ-004 PLC audit trail logs Pass/Fail
See also  Pass Box (Dynamic with HEPA) – IQ Protocol