Hi, Gary,
Several companies I know are using printers that include verification capabilities. These verify the readability and grade the labels according to GS1 standards. The printer/verifiers and software should be validated on installation.
The final lot should be verified as part of your final QC. All QC personnel should be trained on how to use a reader to compare the printed bar code with the DI and PI in the Device History Record. Their signature on the final inspection sheet will confirm the accuracy of the UDI information on the label.
Regards,
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John Minier RAC
Sr. Regulatory Compliance Consultant
JMC Medical, LLC
Highland Mills NY
United States
Original Message:
Sent: 14-Nov-2016 12:02
From: Gary Syring
Subject: UDI Machine Readable Verification
The UDI regulation modifies the QSR device labeling inspection to " ... Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), ..."
What methods have you applied to document a designated individual has examined the machine readable UDI format for accuracy?
Do you use a machine readable verifier as an in-process control to confirm that the printed machine readable symbol meets GS1 or HIBCC standards?
Regards,
Gary Syring
Quality & Regulatory Associates, LLC
800 Levanger Lane
Stoughton, WI 53589
Phone: 608 877-2635
Cell: 608 712-7451
Email: GSyring@QRAsupport.com