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Total Quality

Raise quality and ensure compliance by implementing a comprehensive quality management and compliance solution. Move from reactive to proactive quality management

Improve quality with an effective total quality management solution. 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.

For the Life Sciences industry, ensure proper product approvals and certificates in support of business sustainability as well as product safety and effectiveness.

For compliance managers, implement a well-defined process for requesting, reviewing and approving materials compliance. Assess and document product compliance to meet material regulations.

  • Embed quality throughout the enterprise to reduce recalls, reworks, batch wastage, and improve customer satisfaction.
  • Maintain and accurate Device Master Record that is kept up to date in real-time as product configuration and specifications change.
  • Make better material compliance decisions and ensure accurate compliance reporting.

Roles

  • on cloud
  • on premise
  • All
  • Compliance
  • Quality & Certification
  • Quality & Regulatory for Medical Device
Effectively compare environmental compliance data against material content regulations. Enable managers and design engineers to monitor and analyse materials compliance for better decision making.
Implement a total quality management solution to directly embed quality throughout the enterprise and ensure quality compliance. The result is fewer recalls, reworks, batch wastage, and higher customer satisfaction.
Manage design activities and deliverables with automatic synchronization into a traceable product Design History File (DHF) and simplify Device Master Record (DMR) management.
  • Quality & Regulatory for Medical Device

    DHF Manager for Medical Device

    Manage design activities and deliverables with automatic synchronization  into a traceable product Design History File
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  • Compliance

    Materials Compliance Analyst

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

    Materials Compliance Manager

    Assess and report the compliance of products to material  environmental regulations
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  • Compliance

    Materials Compliance Supplier Representative

    Facilitate the collection of Material Declaration from Suppliers
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  • Quality & Regulatory for Medical Device

    Medical Device Engineer

    Simplify device master record management in a single version of the truth
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  • Quality & Certification

    Quality Assurance Manager

    Integrated close-Loop Quality System from non-conformance reports to corrective and preventive actions
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  • Quality & Certification

    Quality Document Author

    Enterprise Document Control for global collaboration from creation, thru change, to distribution
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  • Quality & Certification

    Regulatory Team Member

    Manage product market submissions, device identification registration and safety events reporting throughout the product lifecycle
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