traceability matrix – Page 2 – Pharma Validation

Analytical Balance (Micro/Semi/Analytical) – 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 Equipment shall provide accurate weighing of samples and standards. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate URS-002 Equipment shall…

Purified Water Generation System (PW 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 System must generate purified water with conductivity ≤ 1 µS/cm H DQ-001 IQ-001 OQ-001 PQ-001 Conductivity Test Report URS-002…

Grade A/B/C/D Cleanrooms (Facility Qualification) – 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 ISO class recovery is within specified limits H DQ-001 IQ-001 OQ-001 PQ-001 Recovery Test Report URS-002 Verify Air…

PLC System (Programmable Logic Controller) – 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 PLC system must execute logic correctly to ensure proper control of manufacturing equipment. H DQ-001 IQ-001 OQ-001 PQ-001…

Biosafety Cabinet (Class II/III) – 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 proper airflow within the cabinet H DQ-001 IQ-001 OQ-001 PQ-001 Airflow Measurement Report [Result] URS-002 Verify HEPA filter…

Raw Material Sampling 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 ID 1] The Raw Material Sampling Booth shall maintain specified air velocity to ensure proper sampling conditions. [H/M/L] [DQ…

Electronic Lab Notebook / Data Capture (if used for GMP) – 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] [URS Statement 1] [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref 1] [PQ…

NDDS Process Control System (PLC/SCADA for microfluidics/homogenizer/TFF) – 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 audit trail access control is functional to maintain data integrity. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail Log…

Automated Visual Inspection (AVI) 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 AVI system shall detect particulate contaminants effectively. H DQ-001 IQ-001 OQ-001 PQ-001 Test Report AVI-001 URS-002 The AVI…

Sterility Test Isolator / System (if NDDS sterile) – 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] [URS_Statement_1] [Risk_Level_1] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1] [URS_ID_2] [URS_Statement_2] [Risk_Level_2] [DQ_Test_Ref_2] [IQ_Test_Ref_2] [OQ_Test_Ref_2] [PQ_Test_Ref_2] [Evidence_Record_2] [Result_2] [URS_ID_3] [URS_Statement_3]…