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Quality and Compliance

Raise quality and ensure compliance

Today, many manufacturers’ have quality management systems that only address quality at a functional level, not enterprise-wide.  The result is no full end-to-end visibility of issues or common use of best practices to optimize quality and quality processes across the organization.   ENOVIA Quality Management provides an effective and efficient quality management system to enforce common quality processes, support global and local regulatory requirements and manage all quality events, such as corrective and preventive actions (CAPA), product nonconformance, and audits, across the enterprise.

In many industries, such as Healthcare and Life Sciences, ensuring regulatory compliance is business critical.  ENOVIA Compliance Management helps ensure proper product approvals and certificates in support of business sustainability as well as product safety and effectiveness.

Global operating companies must ensure materials compliance to regional environmental directives. With ENOVIA Compliance Management, compliance managers can implement a well-defined process for requesting, reviewing, and approving materials compliance.  Product compliance can be assessed and documented to meet material regulations. 

 

 

Key benefits

  • Extend compliance data to a broader audience, allowing for more effective decisions and awareness
  • Integrate supplier declarations early into the product development 
  • Design in material compliance and monitor in real-time
  • Establish end-to-end traceability during the development process that can be leveraged for impact analysis

Roles

  • on cloud
  • on premise
  • All
  • Compliance
  • Quality
ENOVIA Compliance Management helps Compliance Managers structure and implement processes that support organizational adherence to regulatory and material compliance requirements across the product development process.
ENOVIA Quality Management enables Quality Managers to implement a comprehensive quality management solution to directly embed quality throughout the enterprise.  The result is higher quality throughout the organization that results in fewer recalls, reworks, batch wastage, and higher customer satisfaction.  
  • Compliance

    Device Master Record Manager

    on premise
    Simplify device master record management in a single version of the truth
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  • Compliance

    Materials Compliance Analysis

    on premise
    Allow Managers and Designers to use Materials Compliance to make better decisions
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  • Compliance

    Materials Compliance Manager

    on premise
    Assess and report the compliance of products to material  environmental regulations
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  • Quality

    Quality Checks Metrics

    on premise
    Visualize Quality Metrics on Product Data Structure in Dynamic Drill-down 3DDashboards
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  • Quality

    Quality Document Manager

    on premise
    Enterprise Document Control for global collaboration from creation, thru change, to distribution
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  • Quality

    Quality Manager

    on premise
    Integrated close-Loop Quality System from non-conformance reports to corrective and preventive actions
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  • Compliance

    Regulatory Affairs Manager

    on premise
    Manage product market submissions, device identification registration and safety events reporting throughout the product lifecycle
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  • Compliance

    Supplier Materials Compliance Engineer

    on premise
    Facilitate the collection of Material Declaration from Suppliers
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