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ERP System Software Validation - ISO13485 2016 4.1.6

#1
Hi ,
Any advice or guidance from any one on ERP system software validation.
ERP software was purchased of the shelf.
Very low risk associated with it as its used to record stock but we also have a paper based system so it more of a back up.

Need to validate as per ISO13485 2016
4.1.6
"The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software."

Might anyone have a template or sample validation or a validation protocol for the like?

Have been googling but found nothing of any use.

Thanks in advance :)
 
#2
Have you reviewed ISO 80002-2?

I also like Wolf.K's answer on this thread however I am not sure if it is sufficient. Contact the vendor of the software and see if they have any validation scripts or tools. If you are only using it as a backup, then I would think the validation requirements are low..


Thread: elsmar.com/elsmarqualityforum/threads/iso-13485-2016-validate-our-use-of-software-that-impacts-on-the-qms.71197/
 
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