traceability matrix – Page 9 – Pharma Validation

Syringe Stoppering 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 accurate stopper placement in syringes. H DQ-001 IQ-001 OQ-001 PQ-001 Logbook Entry URS-002 Implement reject logic for stopper…

Cap Tightening / Capping 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] The capping machine shall apply torque within specified range. [H/M/L] [DQ Test Ref] [IQ Test Ref] [OQ Test…

Tangential Flow Filtration (TFF) 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 Ensure TMP is maintained within specified limits during operation. H DQ-001 IQ-001 OQ-001 PQ-001 TMP Log [Pass/Fail] URS-002 Verify…

Inline Heater / Heat Exchanger – 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 Inline heater must maintain specified temperature range for bulk solution. H DQ-001 IQ-001 OQ-001 PQ-001 Temp log records Pass/Fail…

Suppository Leak Test 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 Verify the machine can detect leaks in suppositories. H DQ-001 IQ-001 OQ-001 PQ-001 Leak Test Results Log [Result Placeholder]…

Slitting 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] Ensure slitting width is within specified tolerances. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ…

Vial Washing 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 equipment must effectively wash vials to remove contaminants before sterilization. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass…

Plunger Insertion 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 shall accurately insert the plunger into the syringe. [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…

Dropper/Tip Insertion 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 shall ensure proper insertion of dropper tips/nozzles. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…

Ultrasonicator (Probe/Bath) – 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 Ultrasonicator must achieve the specified power amplitude for effective size reduction. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…