MDSAP 8.2.6 CH6 task 17 ANVISA 16/2013 3.2.1 - Label History in Device history record

#1
Hi ,
I am new to the forum so apologies if I am posting incorrectly.

During MDSAP audit a non conformance has been opened under MDSAP 8.2.6 CH6 Task17 , with respect to ANVISA 16/2013 3.2.1 as we do not keep copies of labels with the Device history record. Our current process is we keep a master copy of all labels but not as per the shipment with individual serial/lot numbers

One issue for us is that some regulatory information in printed directly to boxes and we sell low volumes /high mix. (e.g. Single use symbol) Our RA expert interprets the audit finding as meaning that for each HRC we must not only keep a copy of the label but of the box as well. Is this correct?

My interpretation would be we perhaps keep a incoming sample for the print lot for carton, but not a carton for each DHR?
I can understand a requirement to of individual labels with the DHR. ( as single device specific information such as serial number and/or lot number are on the label). But I am not sure how we could keep duplicates of the cartons

Any advice on this?
 

Edward Reesor

Involved In Discussions
#3
We had a suggestion that when we print up labels, we create a separate one to place on/with the paperwork, work order or PO for that run. It might not be electronically copied to a specific folder, but a record of it would still be kept.
 

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