Quality Document 3DExperience

Is an ENOVIA application of the Dassault Systèmes 3DExperience platform to manage the creation, review, implementation, and change processes for quality system documents throughout the lifecycle of the product. It provides harmonization of Document control in accordance with ISO 13485 norm and FDA part 820 regulation and support electronic signature FDA CFR 21 Part 11.

  • Allows consistent execution or the change process for product and quality documents.

  • Supports regulatory needs for managing document and Change Control.

  • Allows Document Templates to be defined.

  • Tracks the Implementation of Controlled Documents in whole organization.


The following capabilities are provided: