Vacuum Degassing 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 ID 1] Ensure the system effectively removes air bubbles from the product. [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] Verify the vacuum pressure is maintained within specified limits. [H/M/L] [DQ Test Ref 2] [IQ Test Ref 2] [OQ Test Ref 2] [PQ Test Ref 2] [Evidence/Record 2] [Result 2]
[URS ID 3] Confirm that degassing time meets the established protocol. [H/M/L] [DQ Test Ref 3] [IQ Test Ref 3] [OQ Test Ref 3] [PQ Test Ref 3] [Evidence/Record 3] [Result 3]
[URS ID 4] Ensure audit trail logs are generated and maintained. [H/M/L] [DQ Test Ref 4] [IQ Test Ref 4] [OQ Test Ref 4] [PQ Test Ref 4] [Evidence/Record 4] [Result 4]
See also  Ophthalmic Sterile Filtration Skid (0.22 µm) – PQ Protocol