| 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 | Temperature should be maintained within specified limits during dissolution. | H | DQ-001 | IQ-001 | OQ-001 | PQ-001 | Temperature log | |
| URS-002 | Agitation time must meet defined specifications to ensure complete dissolution. | M | DQ-002 | IQ-002 | OQ-002 | PQ-002 | Agitation log | |
| URS-003 | Conductivity must be monitored to confirm proper dissolution of solids. | H | DQ-003 | IQ-003 | OQ-003 | PQ-003 | Conductivity records | |
| URS-004 | PLC logs must be accurate and retrievable for review. | M | DQ-004 | IQ-004 | OQ-004 | PQ-004 | PLC log files |