traceability matrix – Page 6 – Pharma Validation

Lyophilizer Vacuum 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 vacuum pressure integrity throughout the lyophilization cycle. H DQ-001 IQ-001 OQ-001 PQ-001 Vacuum Cycle Log Pass/Fail URS-002 Verify…

Cartridge Crimping 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 machine must effectively crimp cartridge seals to ensure product integrity. [H/M/L] [DQ Test Ref] [IQ Test Ref]…

LAF Workstation / Grade A Bench – 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 LAF Workstation must maintain a minimum air velocity of [X] m/s. [H/M/L] [DQ Test Ref 1]…

Aseptic Filling Machine (Vials/PFS/Cartridges) – 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] Aseptic filling of NDDS product must ensure fill accuracy. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…

Otic Drop Filling 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 machine must accurately fill ear drop bottles to the specified volume. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate…

Labeling 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 labeling machine must ensure accurate placement of labels on products. [H/M/L] [DQ Test Ref] [IQ Test Ref]…

Patch Pouch Packaging 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 pack patches into individual pouches. [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 machine shall…

Lyophilizer (Freeze Dryer) – 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 lyophilizer must maintain specified shelf temperature during the freeze-drying process. [H/M/L] [DQ Test Ref 1] [IQ…

Cartridge 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 ID 1] The machine must accurately insert stoppers into cartridges. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1]…

Sterilizing Autoclave (Components) – 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 autoclave must achieve the required F0 value for sterilization. [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] Vacuum…