CAPA & AUDIT 3DEXPERIENCE

Is an ENOVIA application of the Dassault Systèmes platform. It provides a quality management system linked to the lifecycle of the product (from desig to comercialisation). It provides harmonization of CAPA and Audit in accordance with ISO13485 norm and FDA part 820 regulation.

  • CAPA application is based on project management and an integrated management of risks,

  • Audit Application allows quality service to structure and manage Audits.

Those applications provide the following capabilities:

  • CAPA Application

    • Creation of CAPA requests from multiple issue sources,

    • Creation of CAPA from CAPA Request,

    • Setting up milestones and assignation of investigative tasks to multiple users,

    • Creation and management of CAPA Templates,

    • Investigation of CAPA Request.

  • Audit application

    • Creation and management of internal or external quality audit,

    • Creation of Audit Template (Schedule, structure),

    • Management of Audit in Project mode,

    • Creation and management of Audits.

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