| 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 machine must fill the melted base into the molds accurately. | [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 mold temperature must be maintained within specified limits. | [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 process must be effective to solidify the suppositories. | [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] | PLC logs must accurately record the filling process. | [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. | [H/M/L] | [DQ Test Ref 5] | [IQ Test Ref 5] | [OQ Test Ref 5] | [PQ Test Ref 5] | [Evidence/Record 5] | [Result 5] |