Patch Coating Machine (Knife-over-roll / Slot Die) – 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 coat a drug adhesive layer onto the backing film. [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] Coating thickness must be 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] Coating speed must be adjustable and accurately controlled. [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] Coating temperature must be monitored and controlled. [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] Tension during coating must be consistently maintained. [H/M/L] [DQ Test Ref 5] [IQ Test Ref 5] [OQ Test Ref 5] [PQ Test Ref 5] [Evidence/Record 5] [Result 5]
[URS ID 6] PLC logs must accurately record operational parameters. [H/M/L] [DQ Test Ref 6] [IQ Test Ref 6] [OQ Test Ref 6] [PQ Test Ref 6] [Evidence/Record 6] [Result 6]
See also  Sampling Booth (Downflow/RLAF) – DQ Protocol

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