Tag: traceability matrix

Implant Inspection System – 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 system shall accurately inspect implant 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 system shall implement…

Parts Washer – 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 URS001 The Parts Washer must maintain a wash temperature of 60°C. H DQ001 IQ001 OQ001 PQ001 Temperature Log URS002 The…

Coding 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-001 Ensure the coding machine prints batch and expiry information accurately. H DQ-001 IQ-001 OQ-001 PQ-001 Batch Record Pass URS-002…