traceability matrix – Page 6 – Pharma Validation

Safety Device Assembly 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 must accurately assemble safety devices. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ…

Nitrogen Purging System (if used) – 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…

Solvent Addition / Metering Pump – 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…

CCIT System (Vacuum Decay/HVLD) – 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 provide a leak rate sensitivity audit trail. [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…

Aseptic Filling Machine (IV Bottles) – 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 fill volume accuracy within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Volume Calibration Report Pass/Fail URS-002 Verify proper…

Extrusion 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 The extrusion machine must maintain specified extrusion temperature. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs URS-002 The extrusion machine…

Syringe Assembly Machine (Needle Attachment) – 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 accurate needle attachment to syringe. H DQ-001 IQ-001 OQ-001 PQ-001 Audit Trail Log Pass URS-002 Maintain assembly accuracy…

Tube Sealing Machine (Hot Air/Ultrasonic) – 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 machine shall maintain the seal temperature within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature Log URS-002 The…

Nanoparticle Reactor (Batch) – 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 mixing speed is adjustable between 100-1000 RPM. H DQ-001 IQ-001 OQ-001 PQ-001 Mixing Speed Calibration Record URS-002 Temperature…

Leak Test Machine (Container Closure) – 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 Verify leak detection sensitivity meets specifications. H DQ-001 IQ-001 OQ-001 PQ-001 Test Report 001 Pass URS-002 Ensure audit trail…