Integware Medical Devices, PLM, and the FDA

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Integware Medical Devices, PLM, and the FDA

  1. 1. Graciella BeyersDirector of PLMMay 2013MedicalDevices, PLM, and theFDA
  2. 2. 2Integware, Inc. Confidential.© 2013. All Rights Reserved.Quick EXERCISE
  3. 3. TopicsTransforming Medical Device Companieswith PLMCase ExamplesAras PLM for Medical Devices3Integware, Inc. Confidential.© 2013. All Rights Reserved.
  4. 4. Life Sciences Customers4Integware, Inc. Confidential.© 2013. All Rights Reserved.
  5. 5. How do you see the World?Business DimensionProduct Development DimensionQuality Management System DimensionTechnology/Research Management Dimension5Integware, Inc. Confidential.© 2013. All Rights Reserved.ProductLifecycleDimensionsMedicalDeviceCompanies
  6. 6. Enterprise Product Lifecycle – BackbonePLM
  7. 7. It’s just like the human body!ERPMESPLMBusiness IntelligenceCRMBusiness IntelligencePLMCRMMESERP
  8. 8. ManagementPortfolio ManagementResource ManagementProject ManagementManagement ReviewQuality AuditsPersonnel TrainingResearchMarket AnalysisResearch NotesExperiment ManagementScientific Test MethodsTechnical ReportsKnowledge LibraryDevelopmentDesign PlanningRequirementsSpecificationsVerification and ValidationDesign TransferRegulatory ManagementProductionDevice History RecordSupplier QualityProduction ManagementLabeling and PackagingProcess ValidationProduct CatalogQualityCAPANon ConformancesComplaints and eMDRServiceRecall and Field ActionsTrending and AnalysisCAD Integration Bill of Materials Routers Device Master Record ERP IntegrationProduct Documents Quality Documents Change Control Design History File (Docs)Risk ManagementIntelligent Design History FileRepository Information Model Process Model Process Integration Security Search Collaboration ReportingLevel 2 - Controlled Document ManagementLevel 3 - Intelligent EngineeringLevel 4 - Advanced Product Lifecycle ManagementLevel 1 - Product Lifecycle Management PlatformPLM Maturity Model - 2013 Edition
  9. 9. ManagementPortfolio ManagementResource ManagementProject ManagementManagement ReviewQuality AuditsPersonnel TrainingResearchMarket AnalysisResearch NotesExperiment ManagementScientific Test MethodsTechnical ReportsKnowledge LibraryDevelopmentDesign PlanningRequirementsSpecificationsVerification and ValidationDesign TransferRegulatory ManagementProductionDevice History RecordSupplier QualityProduction ManagementLabeling and PackagingProcess ValidationProduct CatalogQualityCAPANon ConformancesComplaints and eMDRServiceRecall and Field ActionsTrending and AnalysisCAD Integration Bill of Materials Routers Device Master Record ERP IntegrationProduct Documents Quality Documents Change Control Design History File (Docs)Risk ManagementIntelligent Design History FileRepository Information Model Process Model Process Integration Security Search Collaboration ReportingLevel 2 - Controlled Document ManagementLevel 3 - Intelligent EngineeringLevel 4 - Advanced Product Lifecycle ManagementLevel 1 - Product Lifecycle Management PlatformPLM Maturity Model - 2013 EditionCAPAManagement ReviewDevice Master RecordComplaints and eMDRQuality Documents
  10. 10. 10FDA Heat!!!Integware, Inc. Confidential.© 2013. All Rights Reserved.IDNumber ofCitations% ofTotal Subsystem Ideal Solution1 453 12% Design Controls PLM2 402 11% Complaints PLM3 378 10% Corrective and Preventive Action [CAPA] PLM4 215 6% Purchasing Controls PLM + ERP5 191 5% Production and Process Controls PLM + ERP +MES6 189 5%Receiving, in-process, and finished deviceacceptance PLM7 167 5% Management Controls PLM + BI8 166 5% Non-Conforming Products PLM9 163 4% Quality Audit PLM10 153 4% Process Validation PLM
  11. 11. ManagementPortfolio ManagementResource ManagementProject ManagementManagement ReviewQuality AuditsPersonnel TrainingResearchMarket AnalysisResearch NotesExperiment ManagementScientific Test MethodsTechnical ReportsKnowledge LibraryDevelopmentDesign PlanningRequirementsSpecificationsVerification and ValidationDesign TransferRegulatory ManagementProductionDevice History RecordSupplier QualityProduction ManagementLabeling and PackagingProcess ValidationProduct CatalogQualityCAPANon ConformancesComplaints and eMDRServiceRecall and Field ActionsTrending and AnalysisCAD Integration Bill of Materials Routers Device Master Record ERP IntegrationProduct Documents Quality Documents Change Control Design History File (Docs)Risk ManagementIntelligent Design History FileRepository Information Model Process Model Process Integration Security Search Collaboration ReportingLevel 2 - Controlled Document ManagementLevel 3 - Intelligent EngineeringLevel 4 - Advanced Product Lifecycle ManagementLevel 1 - Product Lifecycle Management PlatformPLM Maturity Model - 2013 EditionDevice Master RecordBill of MaterialsProduct Documents Change ControlERP IntegrationManagement Review Verification and ValidationDesign History File (Docs)Project ManagementRepository Information Model Process Model Process Integration Security Search Collaboration Reporting99% improvement in time to generateRoutersSupplier QualityQuality DocumentsProcess ValidationDesign PlanningRequirementsSpecificationsRegulatory Documents56% improvement in on-time periodic reviews– ease of reporting48% reduction in volume of COs75% reduction in CO creation time41% reduction in time to process a change75% reduction in validation documentsprocessing time
  12. 12. Mature PLM ScenarioVerification and ValidationSupplier QualityCAPAComplaints ManagementBill of MaterialsERP IntegrationChange ControlRisk Management
  13. 13. Mature PLM ScenarioVerification and ValidationSupplier QualityCAPAComplaints ManagementBill of MaterialsERP IntegrationChange ControlRisk ManagementCustomer Calls with a ComplaintProduct is failing unexpectedlyThe PLM’s analytics toolautomatically identifies a trend
  14. 14. Mature PLM ScenarioVerification and ValidationSupplier QualityCAPA Complaints ManagementBill of MaterialsERP IntegrationChange ControlRisk ManagementThe system sends an alert to a quality analyst on her mobile deviceShe opens a CAPA - (CAPA is a quality process used to overcome orprevent serious problems)
  15. 15. Mature PLM ScenarioVerification and ValidationComplaints ManagementBill of MaterialsERP IntegrationChange ControlRisk ManagementA root cause investigation implicates supplier inconsistenciesA critical parameter had been assumed to be consistent betweensuppliersThe PLM tool easily illustrates this gap due to advanced traceabilityThe system helps the user link together the relevant informationThe system also helps identify which suppliers are qualifiedCAPASupplier Quality
  16. 16. Mature PLM ScenarioVerification and Validation Supplier QualityComplaints ManagementBill of MaterialsERP IntegrationChange ControlThe PLM tool reveals the complaint code indicates a new type offailure mode that was missed in the original risk analysisThe CAPA is used as a central hub to manage the informationCAPARisk Management
  17. 17. Mature PLM ScenarioVerification and Validation Supplier QualityComplaints ManagementERP IntegrationChange ControlThe control plan NOW includes reviewing critical parameters ofthe part during incoming inspectionCAPARisk ManagementBill of Materials
  18. 18. Mature PLM ScenarioVerification and ValidationERP IntegrationA change is invoked and evaluated to update incominginspection proceduresThe change impact tool in PLM looks across affected data todetermine the risk of change and appropriate actionsSupplier QualityComplaints ManagementCAPABill of MaterialsRisk ManagementChange Control
  19. 19. Mature PLM ScenarioThe change is tested and validated and pushed to productionSupplier QualityComplaints ManagementCAPABill of MaterialsRisk ManagementChange ControlVerification and ValidationERP Integration
  20. 20. PLM Maturity Model ® 2013r2 Interfaces Grid - Draft20Integware, Inc. Confidential.© 2013. All Rights Reserved.
  21. 21. Production RecordProduct Information FileDesign History File (Approximate)Product Lifecycle Maturity Model® Chronology21Integware, Inc. Confidential. © 2013. All Rights Reserved.Portfolio ManagementResearchMarketAnalysisPersonnelTrainingDesign PlanningRequirements Product DesignVerification andValidationRegulatoryApprovalSupplierQualityRetirementServiceComplaintsCAD DesignDesign TransferERP IntegrationResource PlanningIdeation Changes(Recorded to DHF)ProcessDesignPackaging &LabelingProductionExtreme Innovation Occurs EarlyMinimum control needed or desiredBest “Right to Market” Opportunities75% Product Cost Determined HereRisk Management FileQuality IssuesRisk Planning Risk Analysisand ControlRiskRe-evaluationSafetyChangeNew Product LifecyclePromotionRiskEvaluationReleaseDisciplined Innovation Occurs HereControlled ChangesSustaining Changes – Very Tightly ControlledImpactAssessedRiskierChangesTrending andAnalyticsEarlyConceptualization
  22. 22. Integware Enterprise “System of Record” Recommendation(R=System of Record, A=System of Access)Medical Device Process FDA QSR ISO 13485: 2003 PLM ERP MES CRM BIQuality Manual All All (4.2.2) RDocument Control 820.25(b), 820.40 4.2.3 R AControl of Records 820.180, 820.186 4.2.4R(Part)R(Part)Management Review & Responsibility 820.5, 820.20, 820.25(b), 820.2504.1, 5.1, 5.2, 5.3, 5.4.1,5.4.2, 5.5, 5.6, 6.1, 6.3, 6.4,8.1, 8.4RTraining 820.25 6.2 R APreventive Maintenance 820.70(g) 6.3 RContract Review 820.25(b) 7.2 RDesign Control, Risk Management 820.25(b) & (b)(2), 820.30, 820.72 (use)7.1, 7.2.1, 7.3 (See alsoISO 14971:2007)R APurchasing & Supplier Control 820.25(b), 820.50 7.4R(Part)/A(Part)R(Part)/A(Part)AReceiving820.25(b), 820.60, 820.65, 820.70, 820.72(use), 820.75, 820.80, 820.86, 820.90,820.120, 820.140, 820.150, 820.180(b),820.2506.4, 7.1, 7.4.3, 7.5.1.1,7.5.1.3, 7.5.3, 7.5.4, 7.5.5,8.2.3, 8.2.4, 8.3RReceiving Inspection820.25(b), 820.60, 820.65, 820.70, 820.72(use), 820.75, 820.80, 820.86, 820.90,820.120, 820.140, 820.150, 820.180(b),820.2506.4, 7.1, 7.4.3, 7.5.1.1,7.5.1.3, 7.5.3, 7.5.4, 7.5.5,8.2.3, 8.2.4, 8.3RManufacturing, Kitting, Product Release, ProductionControl, Process Control, Quality Planning, DHRs820.25(b), 820.60, 820.65, 820.70, 802.72(use), 820.75, 820.80(c), (d), (e), 820.86,820.90, 820.120, 820.130, 820.140,820.150, 820.180(b), 820.184, 820.2505.4.2, 6.4, 7.1, 7.5.1.1,7.5.3, 7.5.4, 7.5.5, 8.2.3,8.2.4, 8.3A RLabeling (product, material, marketing literature)820.40, 820.120 7.5.1.1 g R AShipping 820.130, 820.140, 820.150, 820.160 7.5.5 RCalibration 820.72, 820.25(b), 820.180(b) 7.6 R ?Complaints, MDRCorrections & RemovalsHeath Hazard Evaluation803/804, 820.25(b), 820.100, 820.180(b),820.198, 820.2508.2.1, 8.5.1R(Part)A AR(Part)ADevice Master Record 820.181 8.2.1 R A AInternal Auditing 820.22, 820.25(b), 820.180(b) 8.2.2 R ANonconforming Product 820.60, 820.86, 820.90 8.3 R A ? ACorrective and Preventive Action 820.100, 820.250 8.4, 8.5 R A
  23. 23. ManagementPortfolio ManagementResource ManagementProject ManagementManagement ReviewQuality AuditsPersonnel TrainingResearchMarket AnalysisResearch NotesExperiment ManagementScientific Test MethodsTechnical ReportsKnowledge LibraryDevelopmentDesign PlanningRequirementsSpecificationsVerification and ValidationDesign TransferRegulatory ManagementProductionDevice History RecordSupplier QualityProduction ManagementLabeling and PackagingProcess ValidationProduct CatalogQualityCAPANon ConformancesComplaints and eMDRServiceRecall and Field ActionsTrending and AnalysisCAD Integration Bill of Materials Routers Device Master Record ERP IntegrationProduct Documents Quality Documents Change Control Design History File (Docs)Risk ManagementIntelligent Design History FileRepository Information Model Process Model Process Integration Security Search Collaboration ReportingLevel 2 - Controlled Document ManagementLevel 3 - Intelligent EngineeringLevel 4 - Advanced Product Lifecycle ManagementLevel 1 - Product Lifecycle Management PlatformPLM Maturity Model - 2013 Edition
  24. 24. ManagementPortfolio ManagementResource ManagementProject ManagementManagement ReviewQuality AuditsPersonnel TrainingResearchMarket AnalysisResearch NotesExperiment ManagementScientific Test MethodsTechnical ReportsKnowledge LibraryDevelopmentDesign PlanningRequirementsSpecificationsVerification and ValidationDesign TransferRegulatory ManagementProductionDevice History RecordSupplier QualityProduction ManagementLabeling and PackagingProcess ValidationProduct CatalogQualityCAPANon ConformancesComplaints and eMDRServiceRecall and Field ActionsTrending and AnalysisCAD Integration Bill of Materials Routers Device Master Record ERP IntegrationProduct Documents Quality Documents Change Control Design History File (Docs)Risk ManagementIntelligent Design History FileRepository Information Model Process Model Process Integration Security Search Collaboration ReportingLevel 2 - Controlled Document ManagementLevel 3 - Intelligent EngineeringLevel 4 - Advanced Product Lifecycle ManagementLevel 1 - Product Lifecycle Management PlatformPLM Maturity Model - 2013 Edition
  25. 25. Potential for ArasThese are things that are getting us excitedOpen platformAdvanced reportingBetter fundamental building blocksServicesProductFull business process flows

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