Off the Shelf Software VISUAL ERP system

love02eat

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#1
We are currently trying to validate our off the shelf software Visual ERP system 9.1 to be compliant to ISO13485:2016 4.1.6. We were having some issues with the visual quality module. We contacted INFOR (visual) and wanted to know what version we were having issues with since they are changing the system now to 9.2. With this knowledge of forcing us to launch to the 9.2 what do we do with all the work we put into validating 9.1.
 
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yodon

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#2
You'll need to assess the change to determine impact on validation (which, obviously, there will be some!). Then you do whatever re-validation is necessary to bring the system back to a validated state.

The work you put into validation 9.1 should give you a higher jumping off point for 9.2.

Do note that validation is never intended to be a one-time event. Changes will be continual throughout the usage life. This could include updates by the vendor, changes in the way you use the system, changes to your infrastructure, etc. All of these have a potential to take the system out of a validated state and need to be assessed to determine what needs to be done to bring it back.
 
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