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Complaints & Non-conformances  3DExperience

Is an ENOVIA application of the Dassault Systèmes platform to manage complaints, equipment service requests and Nonconformances (NC) from identification and product evaluation to closure It provides harmonization of complaints and non-conformances in accordance with ISO 13485 norm and FDA part 820 regulation.

This app allows users to report occurrences with product models and patients. It allows companies to investigate requests and solve issues.

 

This application provides the following capabilities:

 

  • Complaint management process

    • Creation of Complaints to record problems encountered by customers with product models

    • Evaluation of details provided in the complaint

    • Integration onto CAPA and Audit process (CAPA creation in case of necessity)

  • Non-Conformances management

    • Identification of non-conforming products and/or process

    • Investigation of these non-conformances

    • CAPA creation in case of necessity

    • Planning for changes