Tag: traceability matrix

CO2 Incubator – 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 temperature is maintained within specified range. H DQ-Temp-001 IQ-Temp-001 OQ-Temp-001 PQ-Temp-001 Temp Log Report Pass URS-002 Ensure CO2…

Ambient Warehouse – 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 Ambient Warehouse must maintain temperature within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Mapping Report URS-002 Ambient Warehouse…

Top Pan Balance – 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 top pan balance must accurately weigh bulk samples within specified limits. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…

AHU for Aseptic Area – 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 AHU shall maintain the required Air Changes per Hour (ACH) for the aseptic area. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1]…

SCADA 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-001 The SCADA System must provide an audit trail for all user activities. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail…

Laminar Air Flow (LAF) – 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 The Laminar Air Flow (LAF) must provide aseptic protection during operations. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass/Fail…

Dispensing Booth – 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 The dispensing booth shall maintain a minimum air velocity of 0.45 m/s at the work surface. H DQ-001 IQ-001…