Hi,
my NB asked for the validation of the process for releasing the UDI.
We have a SOP describing how the UDI is assigned and a spreadsheet containing the list of the UDI-DI for each device and configuration. In the same spreadsheet we register the UDI-PI each time. (We are a small company with not so many UDI-DI, but with a number of UDI-PI. We manufacture low risk class IIa devices, a mistake in the UDI may result in a logistic/regulatory issue - no harms to patients/users).
The UDI-DI is indicated in the DMR, while the UDI-PI is defined by the production dep. according to LOT number, manufacturing date, and so on and reviewed. The production dep. has a program for printing the UDI, in the format of GS1 data-matrix, on the stickers that are applied on each device. Finally, GS1 data-matrix codes printed on the stickers are checked by sample with a barcode verifier (verification).
How would you validate this process (= confirm that the data content within a barcode is correct) ?
Thank you for any input you can give me!
my NB asked for the validation of the process for releasing the UDI.
We have a SOP describing how the UDI is assigned and a spreadsheet containing the list of the UDI-DI for each device and configuration. In the same spreadsheet we register the UDI-PI each time. (We are a small company with not so many UDI-DI, but with a number of UDI-PI. We manufacture low risk class IIa devices, a mistake in the UDI may result in a logistic/regulatory issue - no harms to patients/users).
The UDI-DI is indicated in the DMR, while the UDI-PI is defined by the production dep. according to LOT number, manufacturing date, and so on and reviewed. The production dep. has a program for printing the UDI, in the format of GS1 data-matrix, on the stickers that are applied on each device. Finally, GS1 data-matrix codes printed on the stickers are checked by sample with a barcode verifier (verification).
How would you validate this process (= confirm that the data content within a barcode is correct) ?
Thank you for any input you can give me!