Barcode Scanners

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
#1

An audit finding specified that we werent performing periodic performance checks on barcode scanners (used on the production floor for data entry to the AS400 and other systems). The functionality of the scanners (as part of the system under test) were verified during OQ before release but they are not periodically re-tested to verify performance. Is there a known risk of performance degradation on barcode scanners? If so, does anyone have a recommendation on periodic performance checks?

Thank you,
Durwvd

#2

Never heard of a barcode scanner that went bad and it wasn’t obvious.

Audit findings should be tied to a requirement. I can see that this could be tied to something like (presuming 13485) 7.5 (esp. 7.5.2) but would be curious what the exact finding was. It could be that your internal procedures require a periodic check of all equipment.

If it’s just a general finding (i.e., not tied to processes you have specifically identified), you may be able to just do a risk analysis, identify failure modes, and show that failure would be obvious and there’s no risk of introducing invalid data. Another option is to verify it before each use (session) but then you get into having to show proof that it was done, etc. Other than that, you’ll need to define the period (again, based on risk) and perform the check (with documented evidence of doing so, of course). It would be a good idea to tie this to a Master Validation Plan, whichever approach you take.