| 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 | The emulsification system shall produce uniform emulsion droplets for microspheres. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Documented results of droplet size analysis | [Result] |
| URS-002 | The system must maintain specified shear rate during operation. | H | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Calibration records of shear rate sensors | [Result] |
| URS-003 | The emulsification process shall operate within defined flow temperature ranges. | M | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Temperature monitoring logs | [Result] |
| URS-004 | The system shall accurately record pressure during emulsification. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | Pressure validation records | [Result] |
| URS-005 | The emulsification system must maintain accurate records of all critical parameters. | L | DQ-005 | IQ-005 | OQ-005 | PQ-005 | System log files | [Result] |