Fluid Bed Dryer (if used) – 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 Fluid Bed Dryer operates within specified airflow parameters. M DQ-001 IQ-001 OQ-001 PQ-001 Airflow Calibration Report
URS-002 Verify that the product temperature remains within acceptable limits during drying. H DQ-002 IQ-002 OQ-002 PQ-002 Temperature Monitoring Logs
URS-003 Confirm that all temperature records are accurately documented and retrievable. M DQ-003 IQ-003 OQ-003 PQ-003 Record Retrieval Audit
URS-004 Ensure that the drying/granulation process is reproducible and consistent. L DQ-004 IQ-004 OQ-004 PQ-004 Process Validation Report
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