Does Solidworks (2D/3D drafting modules) need validation?

#1
Hello all,

As of today we are informed that aside from simulation modules of Solidworks such as 2D/3D drafting modules are needed to undergo validation procedures.
Can anyone help me understand what do I need to validate specifically? Especially do I need to perfom validation or verification?

Also do we really need to validate/verify these modules? This question stems from the research I did about Solidworks related validations on internet and the resulting attached file for validation of Solidworks Simulation modules. If the simulation module is validated can I also assume that the 2D/3D drafting modules used as the basis for the simulation is also validated in proxy.

I am hoping that ideas and further discussions on the subject will prove helpful to us.

P.S. Not a native English speaker so please do forgive grammar/logic errors as I am currently trying to translate my thoughts.

https://www.google.com/url?sa=t&rct...lish2019.pdf&usg=AOvVaw3VQJpJ0b7QT8YFLaXpQcIy
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#3
@Yavuz Şağban - Please note that we do not allow copyrighted documents to be posted here. The file which was was in the first post been replaced with a link to the file which was attached.
 
#5
Here is a link discussing validation I just went through something similar and the auditor just wanted to verify we had the certificate of authenticity.
Thanks for the information, can you expand a little more about the subject? Did the auditor ask for the certificate of authenticity of Solidworks and never mention validation?
 

al40

Quite Involved in Discussions
#6
Thanks for the information, can you expand a little more about the subject? Did the auditor ask for the certificate of authenticity of Solidworks and never mention validation?
Yes, all he ask for was did we have the certificate of authenticity. Also for your information if you do some research on line you will find that Solidworks has a enterprise PDM (Product data management) which has been designed and developed to help companies in the medical field comply with the guidelines and requirements of the FDA’s 21 CFR Part 11 rule which may be what you're looking for we have this module in our system that the design engineers use as well.

Best,
Al40
 
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