| 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 system shall provide a leak rate sensitivity audit trail. | [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 system shall ensure compliance with regulatory standards for container closure integrity testing. | [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 system shall maintain an electronic audit trail of all test results. | [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 system shall allow for user access control and permissions. | [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] | The system shall provide real-time monitoring of leak test results. | [H/M/L] | [DQ_Test_Ref_5] | [IQ_Test_Ref_5] | [OQ_Test_Ref_5] | [PQ_Test_Ref_5] | [Evidence_Record_5] | [Result_5] |