Suppository Base Melting Vessel (Jacketed SS) – 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 melting vessel must maintain a uniform temperature for effective melting of PEG. [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 jacketed design must provide adequate insulation to prevent heat loss. [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] The vessel must be constructed from stainless steel to ensure compatibility with PEG. [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] The melting vessel must have a means of temperature control and monitoring. [H/M/L] [DQ Test Ref 4] [IQ Test Ref 4] [OQ Test Ref 4] [PQ Test Ref 4] [Evidence/Record 4] [Result 4]
[URS ID 5] The system must be easy to clean to prevent cross-contamination. [H/M/L] [DQ Test Ref 5] [IQ Test Ref 5] [OQ Test Ref 5] [PQ Test Ref 5] [Evidence/Record 5] [Result 5]
See also  Cartoning Machine – Validation Summary Report (VSR) Template