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

B

Bernard Mulcahy

#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?
 
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Edward Reesor

Trusted Information Resource
#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.
 

RCW

Quite Involved in Discussions
#4
We have been printing 2 labels, one to attach to the medical device and one to attach to the DHR paperwork, for a while now and it has worked well for us.

My company would like to move to full electronic capture for the DHR records such that there would be no paper traveler (router) or any other paperwork to attach the label too. Does it meet requirements to have and maintain either a photo or electronic scan of the actually label? This could be saved as an attachment to the electronic record however I don't know if an actual physical label is required for review. Does anyone currently save theirs electronically? Any pushback on this from outside sources?
 
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