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UDI Label Verification - How do we ensure the barcode is correct and prove it?
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UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
UDI Label Verification - How do we ensure the barcode is correct and prove it?
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UDI Label Verification - How do we ensure the barcode is correct and prove it?


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Some Related Topic Tags
labeling content, unique device identification (udi)
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  Post Number #1  
Old 1st May 2017, 11:54 AM
cabjerk

 
 
Total Posts: 9
Question UDI Label Verification - How do we ensure the barcode is correct and prove it?

Hello,

From the FDA view point "how do you ensure that barcode will print out correct each and every time?" Our systems have been validated, but how do we ensure the barcode is correct and prove it?

If this has been asked before please send me the link. Did a search and could not find anything.

Any feedback on this will be great?

Thank you,

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  Post Number #2  
Old 1st May 2017, 01:46 PM
Mark Meer

 
 
Total Posts: 667
Re: UDI Label Verification - How do we ensure the barcode is correct and prove it?

Here are links to few previous threads:

UDI (Unique Device Identification) Verification Requirements



820.120 UDI (Unique Device Identification) Labeling Verification Requirements


UDI (barcode, datamatrix) Verification Solutions

As I recall, there was no consensus, other than that the safest (and, of course, most expensive) option is to invest in some sort of automated equipment. Every single barcode need not necessarily be checked, but perhaps the first and last off a batch might be a suggestion, depending on product/volume/capabilities...

MM.

Last edited by Mark Meer; 1st May 2017 at 01:54 PM.
Thank You to Mark Meer for your informative Post and/or Attachment!
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  Post Number #3  
Old 17th July 2017, 01:08 PM
JJLit

 
 
Total Posts: 11
Re: UDI Label Verification - How do we ensure the barcode is correct and prove it?

The direction that we took was to buy a calibrated verification unit. For our purposes, scanning each barcode works very well. The unit produces a report with the barcode quality grade. You can automate these units in any way that you want.
  Post Number #4  
Old 23rd August 2017, 08:52 AM
Haddad9921

 
 
Total Posts: 22
Please Help! Re: UDI Label Verification - How do we ensure the barcode is correct and prove it?

Hi,
I don't know if this is the right place to ask this question. I am looking for a barcode challenging procedure to test for accuracy of readability. This is a requirement for food packaging manufacturers. Let me know if you have one you can share or if you can direct me to where I can find one.
Thank you
  Post Number #5  
Old 23rd August 2017, 03:38 PM
Mark Meer

 
 
Total Posts: 667
Re: UDI Label Verification - How do we ensure the barcode is correct and prove it?

Suggest checking the links to other threads I posted previously here (Post #2), where this has been discussed.

I'd attempted to justify a more simplified procedure that does not involve specialized equipment...but I think the general consensus is that some sort of dedicated barcode verification equipment/scanner is necessary. How often you want to verify is up to you. You can setup an automated system that checks every label off the production line, or setup a system of spot-checking (for example, maybe the first and last label for every batch).
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