SOFTWARE VALIDATION In relation to ISO 13485:2016
We have a query regarding SOFTWARE VALIDATION In ISO 13485:2016, Is it mandatory to have validation?
Software vendor is not willing to provide us certificate
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According to the requirement 4.1.6 organization must document procedures for the validation of the application of computer
software used in the quality management system. Software must be validated prior to initial use and after changes to such software or its application. It is mandatory to have a record of such maintenaince.
If the vendor does not provide you a validation certificate, you can perform the validation by yourself, considering the aspects of the software that is most importa for you.
For more detailes How to establish process validation in the QMS you can find in this article: https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/
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Mar 02, 2020