Depyrogenation Tunnel – 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 tunnel maintains the required temperature profile for effective depyrogenation. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs, Calibration records Pass
URS-002 Verify the belt speed is consistent with the validated process parameters. M DQ-002 IQ-002 OQ-002 PQ-002 Belt speed logs, Calibration records Pass
URS-003 Confirm that endotoxin reduction is achieved as per specifications. H DQ-003 IQ-003 OQ-003 PQ-003 Endotoxin test results, Validation reports Pass
URS-004 Ensure PLC logs are maintained and accessible for review. L DQ-004 IQ-004 OQ-004 PQ-004 PLC log records, Audit trails Pass
See also  Bin Lifter / IBC Lifter – DQ Protocol