Leak Test Machine (Bottle) – Traceability Matrix (URS ↔ Tests)

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 equipment shall perform leak testing on bottles to ensure integrity. [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 machine shall have an audit trail for all test results. [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 sensitivity of the pressure decay test must meet defined specifications. [H/M/L] [DQ_Test_Ref_3] [IQ_Test_Ref_3] [OQ_Test_Ref_3] [PQ_Test_Ref_3] [Evidence_Record_3] [Result_3]
See also  Ophthalmic Bottle Washing Machine – DQ Protocol

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