Bill of Materials Management Configuration And Change Management Design Management IP Classification And Protection Product Planning And Program Management Quality And Compliance Strategic Customer Relationships Strategic Supplier Relationships WANT TO MORE ABOUT ENOVIA [cf7sr-simple-recaptcha] Need Help?Please Feel Free To Contact Us. We Will Get Back To You With 1-2 Business Days.contact@xd-innovation.websitepro.hosting 1-855-XDI-TEAM Extend compliance data to a broader audience, integrate supplier declarations early into the product development, design in material compliance and monitor in real-time, as well as establish end-to-end traceability during the development process that can be leveraged for impact analysis. 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 High Tech, 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 RolesDEVICE MASTER RECORD MANAGER Simplify device master record management in a single version of the truth A single version of the truth—the latest product information, captured in a centralized environment. Enterprise change control process between parts, specification and technical documents Baseline Device Master throughout product evolution Consume Device Master Record documents with a simple package and download MATERIALS COMPLIANCE ANALYSIS Allow Managers and Designers to use Materials Compliance to make better decisions Allow managers to assess product compliance and supplier reporting status Make outsourcing decisions based on environmental compliance or supplier responsiveness Maximize use of compliant components to create eco-friendly designs Track conflict mineral reporting status and rolled up smelter content MATERIALS COMPLIANCE MANAGER Assess and report the compliance of products to material environmental regulations Calculate product compliance to industry and regional regulations from component material declarations Manage the collection of of material declarations from your supplier chain Determine the impact of design and outsourcing decisions on the compliance of a product Perform in-depth analysis to determine root cause of compliance problems Report product compliance to your customers using industry standards QUALITY CHECKS METRICS Visualize Quality Metrics on Product Data Structure in Dynamic Drill-down 3D Dashboards Ensures companies follow and maintain model’s quality Supports companies in checking the quality of suppliers’ models Enables managers to make decisions based on facts QUALITY DOCUMENT MANAGER Enterprise Document Control for global collaboration from creation, thru change, to distribution Drive consistency with an enterprise change process across all organizations Ensure relevance of the documents intended usage with Periodic review Training sign-offs with Read and Understand Statements Manage distribution of hard copy prints with controlled printing Support for electronic signature FDA CFR 21 Part 11 QUALITY MANAGER Integrated close-loop Quality System from non-conformance reports to corrective and preventive actions Standardize the development of a closed-loop, holistic approach to CAPA activities and management Manage complaint handling processes from identification and product evaluation to closure Manage deviation/nonconformance identification, reporting, disposition, and resolution, with explicit documentation to ensure quality standards and compliance Manage audit activities and processes from scheduling to execution to ensure quality assurance and quality systems are working as defined and approved REGULATORY AFFAIRS MANAGER Manage product market submissions, device identification registration and safety events reporting throughout the product lifecycle Streamline and automate the regulatory submission planning and dossier management and approval processes Manage Device Identification data and submissions Manage adverse events from reportability evaluation, submission to closure SUPPLIER MATERIALS COMPLIANCE ENGINEER Supplier Materials Compliance Engineer Secure environment for suppliers to view part requests and upload material declarations Material declarations can be submitted in industry standard formats such as IPC 1752, JAMP, and Compliance Connect Online editor provided for creating detailed material declarations for requested parts Uploaded material declarations are automatically imported into Materials Compliance Manager
