8 Replies Latest reply on Mar 27, 2018 1:11 PM by Michael Kolias

    Solidworks ePDM Validation

    Michael Kolias

      I am looking for some help trying to find validation documentation for ePDM. My organization is a life sciences company that is subject to FDA compliance. We are getting ready to kickoff the implementation of Solidworks ePDM but require help with the documents such as the SRS, Val Plan, IQ, OQ. I am surprised that Solidworks does not sell a standard toolkit that contains the SRS, IQ, and OQ documents. These documents, more than anything, could be standardized and updated as new versions of the product are released. It would be great if there was a package I could purchase as a baseline that can be modified based on our configuration. Does anyone have any thoughts on something that may be available for us to leverage? Appreciate the help in advance.

       

      Thank you!