Tablet Compression Machine (Double Rotary) – 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 must operate at a specified speed for optimal tablet production. [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 must maintain force control within specified limits during operation. [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 machine must accurately control the weight of tablets produced. [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 machine must have an effective reject mechanism for defective tablets. [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  Capsule Filling Machine (Automatic) – IQ Protocol