Bill of Materials ManagementConfiguration And Change ManagementDesign ManagementIP Classification And ProtectionProduct Planning And Program ManagementQuality And ComplianceStrategic Customer RelationshipsStrategic Supplier RelationshipsWANT 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-TEAMExtend 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 BENEFITSExtend compliance data to a broader audience, allowing for more effective decisions and awarenessIntegrate supplier declarations early into the product developmentDesign in material compliance and monitor in real-timeEstablish end-to-end traceability during the development process that can be leveraged for impact analysisRolesDEVICE MASTER RECORD MANAGERSimplify device master record management in a single version of the truthA single version of the truth—the latest product information, captured in a centralized environment.Enterprise change control process between parts, specification and technical documentsBaseline Device Master throughout product evolutionConsume Device Master Record documents with a simple package and downloadMATERIALS COMPLIANCE ANALYSISAllow Managers and Designers to use Materials Compliance to make better decisionsAllow managers to assess product compliance and supplier reporting statusMake outsourcing decisions based on environmental compliance or supplier responsivenessMaximize use of compliant components to create eco-friendly designsTrack conflict mineral reporting status and rolled up smelter contentMATERIALS COMPLIANCE MANAGERAssess and report the compliance of products to material environmental regulationsCalculate product compliance to industry and regional regulations from component material declarationsManage the collection of of material declarations from your supplier chainDetermine the impact of design and outsourcing decisions on the compliance of a productPerform in-depth analysis to determine root cause of compliance problemsReport product compliance to your customers using industry standardsQUALITY CHECKS METRICSVisualize Quality Metrics on Product Data Structure in Dynamic Drill-down 3D DashboardsEnsures companies follow and maintain model’s qualitySupports companies in checking the quality of suppliers’ modelsEnables managers to make decisions based on factsQUALITY DOCUMENT MANAGEREnterprise Document Control for global collaboration from creation, thru change, to distributionDrive consistency with an enterprise change process across all organizationsEnsure relevance of the documents intended usage with Periodic reviewTraining sign-offs with Read and Understand StatementsManage distribution of hard copy prints with controlled printingSupport for electronic signature FDA CFR 21 Part 11QUALITY MANAGERIntegrated close-loop Quality System from non-conformance reports to corrective and preventive actionsStandardize the development of a closed-loop, holistic approach to CAPA activities and managementManage complaint handling processes from identification and product evaluation to closureManage deviation/nonconformance identification, reporting, disposition, and resolution, with explicit documentation to ensure quality standards and complianceManage audit activities and processes from scheduling to execution to ensure quality assurance and quality systems are working as defined and approvedREGULATORY AFFAIRS MANAGERManage product market submissions, device identification registration and safety events reporting throughout the product lifecycleStreamline and automate the regulatory submission planning and dossier management and approval processesManage Device Identification data and submissionsManage adverse events from reportability evaluation, submission to closureSUPPLIER MATERIALS COMPLIANCE ENGINEERSupplier Materials Compliance EngineerSecure environment for suppliers to view part requests and upload material declarationsMaterial declarations can be submitted in industry standard formats such as IPC 1752, JAMP, and Compliance ConnectOnline editor provided for creating detailed material declarations for requested partsUploaded material declarations are automatically imported into Materials Compliance Manager