traceability matrix – Page 12

Patch Inspection Machine (Vision 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 system shall accurately detect patch dimensions. H DQ-001 IQ-001 OQ-001 PQ-001 Dimension Test Report Pass URS-002 The system…

Sterile Powder 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 sterile solution into vials. H DQ-001 IQ-001 OQ-001 PQ-001 Filling Accuracy Report Pass/Fail URS-002…

Syringe 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 1] The machine must securely crimp seals on syringes. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1]…

Ophthalmic Bottle 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 ID 1] Ensure the washing machine operates at the specified wash pressure. [H/M/L] [DQ Test Ref 1] [IQ Test…

Ultrafiltration/Diafiltration (UF/DF) Skid – 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 membrane integrity during operation H DQ-001 IQ-001 OQ-001 PQ-001 Membrane Integrity Records URS-002 Maintain specified pressure limits H…

Vent Filter Assembly – 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] Ensure the Vent Filter Assembly maintains sterility of the holding vessel. [H/M/L] [DQ Test Ref] [IQ Test Ref]…

Inline pH Control 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 system shall accurately control pH levels during compounding. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Records Pass/Fail URS-002 The…

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