Plunger Insertion Machine – 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 machine shall accurately insert the plunger into the syringe. [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 insertion force shall be monitored and logged. [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 reject logic shall function correctly to prevent defective syringes. [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] Audit trail logs must be maintained for all operations. [H/M/L] [DQ_Test_Ref_4] [IQ_Test_Ref_4] [OQ_Test_Ref_4] [PQ_Test_Ref_4] [Evidence_Record_4] [Result_4]
See also  Fluid Bed Dryer (FBD) – IQ Protocol

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