| URS ID | URS Statement | Risk (H/M/L) | DQ Test Ref | IQ Test Ref | OQ Test Ref | PQ Test Ref | Evidence/Record | Result |
|---|---|---|---|---|---|---|---|---|
| [URS ID 1] | The cooling tunnel must maintain the specified cooling temperature for suppositories. | [H/M/L] | [DQ Test Ref 1] | [IQ Test Ref 1] | [OQ Test Ref 1] | [PQ Test Ref 1] | [Evidence/Record 1] | [Result 1] |
| [URS ID 2] | The cooling conveyor must provide adequate airflow to ensure uniform cooling. | [H/M/L] | [DQ Test Ref 2] | [IQ Test Ref 2] | [OQ Test Ref 2] | [PQ Test Ref 2] | [Evidence/Record 2] | [Result 2] |
| [URS ID 3] | The cooling time must be validated to ensure product integrity. | [H/M/L] | [DQ Test Ref 3] | [IQ Test Ref 3] | [OQ Test Ref 3] | [PQ Test Ref 3] | [Evidence/Record 3] | [Result 3] |
| [URS ID 4] | The PLC must log all critical parameters during operation. | [H/M/L] | [DQ Test Ref 4] | [IQ Test Ref 4] | [OQ Test Ref 4] | [PQ Test Ref 4] | [Evidence/Record 4] | [Result 4] |
| [URS ID 5] | An audit trail must be maintained for all operations of the cooling tunnel. | [H/M/L] | [DQ Test Ref 5] | [IQ Test Ref 5] | [OQ Test Ref 5] | [PQ Test Ref 5] | [Evidence/Record 5] | [Result 5] |