| 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 | Verify the spheronizer operates within specified plate speed. | M | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Calibration Certificate | Pass |
| URS-002 | Confirm the spheronization time is within the defined limits. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Validation Report | Pass |
| URS-003 | Assess the particle size distribution (PSD) shape during operation. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | PSD Analysis Report | Pass |