“The FDA says the UDI label must convey the right information about the product and be easily scanned by all”
It sounds easy but when you dig into it you realize that there is a bit more to it. Hidden characters, strict data formatting rules, matching with the GUDID database, barcode ISO print quality and size minimums, human readable layout, etc. can all present challenges (and a lot of work) for medical device companies. A person might be able to do one or two manually, but it really is a task for a system designed to catch all the troublesome nuances before you send them out the door and a customer or regulator catches them. Our SCANALYST systems have been designed for just such a task.
And now you can benefit from the expertise built into SCANALYST (as well as the folks behind it) very easily and at low cost.
We will inspect your UDI labels for:
- Barcode print quality (ISO) – are you above the defined minimum?
- Barcode multi-field format – is the layout of the multiple data fields in the barcode correct?
- Barcode field content – each individual field must be formatted correctly, contain valid information and be in the proper sequence?
- Barcode size – above the minimums?
- Human readable data – format and position correct?
- GUDID Match – is the data expected to be in the barcode actually there? Or not?
A problem in any one of these parameters could cost a customer or cause a recall. There is a lot of risk that can be alleviated at a relatively low cost.
- Cost: $100 per label (call or email below for volume discounting)
- Turnaround Time: 1-2 Days after a physical label is received
If you are at the center of your supply chain, then you know how difficult it is to manage a system that has a ‘loose’ foundation. SCANALYST inspections can help you with your supply chain optimization. Trading partners can be validated as they are brought on or annually to insure they can move their products smoothly through your automation and business systems. ‘Step it up’ to avoid any difficulty scanning products. Your suppliers ability to comply is important in all supply chains but especially important in healthcare, fulfillment centers and any supply chains that are highly automated. Call us, we have helped others and we can help you as well. We would be glad to discuss your needs and provide a solution.