Barcode Inventory System Validation

A

Aliasanonymous

Dear experts of the cove,

Does anyone know if a barcode inventory system for control of in/out movement of stock requires validation, as per ISO 13485? (Is this considered a software for processes??)

If so, would validation done at the manufacturer of the system be accepted?
Or would a validation protocol, WI, etc be required on our side? Anybody has an example?

Thank you!
 
S

stephano2013

A barcode inventory system for control of in/out movement of stock requires a validation, because the data in the system could affect the ability of the product to conform to specifications.

You need a complete validation record of your system, not only one at the manufacturers site.
 
A

Aliasanonymous

Thank you or the reply.

I thought so too...
But I have no idea how to go about doing it.. Does anybody have a validation plan for such?
 
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