Quality and Compliance Management

Target Zero Rework

Today, effective quality practices have involved formalizing a process after a quality issue has been found or raised. These issues come from the field, or from the development and launch process itself. Some solutions focus on the various tools for quality issue prevention, such as Quality Functional Deployment (QFD), Failure Mode and Effect Analysis (FMEA), etc. These disciplines and processes have been touted as the mechanism for issue prevention and quality improvement for years.

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

KEY PROCESSES

  • Materials Compliance Management

    Manage Full Range of Products Environmental Compliance Information and Material Regulations

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  • Materials Compliance Declaration

    Gathering Material Declarations From the Supply Chain for Outsourced Parts in Products

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  • Materials Compliance Analysis

    Monitor, Analyze and Control Materials Compliance Information for Better Decision Making

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  • Quality Management

    Integrated Closed-Loop System for Full Range of Quality Management From Non-Conformance Reports to Corrective and Preventative Actions

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  • Quality Management for Life Sciences

    Closed-Loop Process for Managing Customer Complaints and Regulatory Reporting

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  • Quality-Based Document Control

    Document Management for Enterprise-Wide Collaboration While Ensuring Regulatory Compliance

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  • BOM and DMR Management

    Provides a "Living" DMR for Full Traceability and Automated reporting

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  • Global Market Registration

    Expedite Premarket Approval With Efficient Document Submissions

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