Barcode Validation


In my company, we are going to establish a method to read a barcode from the Batch Record in order to avoid mistakes when people choose a substance. So the process will be:

  1. Read the barcode from the Batch Record
  2. Read the substance barcode

Then the system compares both barcodes and give a message to the operator.

What kind of validation must be done here?

Thanks in advance!

Not sure how much help this will be but I’ll try to get it started seeing as there’s been no response yet.

We have a client that uses barcode readers in a medical device. We did some basic verification to show that the barcodes read good barcodes correctly, correctly didn’t read bad barcodes, etc. The FDA was still a bit concerned that they may get a good read on one reader but get a different read on a different reader. We have a good case, I think, that using code 128C includes a check-bit; so if you get a read at all on any reader, you’re guaranteed a ‘proper’ read.

In any case, we beefed up the ‘challenge’ cases in the testing and have the code 128C story in our hip pocket for the next review. We’re also using CCD cameras which are supposed to be more robust (forgiving) than laser line scanners. So we’ll see how it goes.

Now in your case, it sounds like you have a bit more software involved than just the reading. If this is for something in the medical / pharma field, I presume you’d need to validate the software, too. A good start would be a risk analysis there.

Finally, it sounds like the results may be used as quality records. If that’s the case, Part 11 may come into play. That’s a bit out of my field so you may want to solicit help from other areas if you feel you may need to comply with Part 11.