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SOFTWARE VALIDATION In relation to ISO 13485:2016

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Guest user Created:   Mar 02, 2020 Last commented:   Mar 02, 2020

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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Mar 02, 2020

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

Mar 02, 2020

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