managing quality across the enterprise

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Enterprise Quality Management Solution for Medical Device CompaniesManaging Quality Across the Enterprise1

2Why Is Quality Important to Your Business Ecosystem?R&DPRODUCT INTROEXPANDING MARKETSGROWTH & MATURITY

Life Science IndustryBrand protection


$Cost, Price & MarginsVendor Network

Speed to Market

Consistent Delivery


Sparta Systems Proprietary2

The Challenge3Company Develops products to satisfy the needs of consumersFinance & Purchasing

Focused on performance management and reducing costs

SuppliersSupplies safety and high quality raw materials and packagingNo quality Visibility?Issue Resolution Cost:CAPA 2Change Control 2Deviations 2CAPA 3Change Control 3Deviations 3Disparate ProcessesCAPA 1Change Control 1Deviations 1?

Regulatory Bodies



How many people impactyour product across theecosystem?1x10x100x1000xContract Manufacturers & PackagersHandles outsourced manufacturingand packaging for brand owner ?No quality Visibility

Sparta Systems Proprietary3

Addressing the Challenge4

FragmentedIncompleteLack of consistencyPath to SuccessERP$

End-to-End Quality ManagementInternal Facility Worldwide Facilities Vendor FacilitiesSupply Chain Mgmt.Reduced Risk IT Efficient

Functional AreaInternal ManufacturingExternal ManufacturingR&DSupplier ManagementGeographyCountryRegionBusiness UnitOperationally EfficientQuality ProcessCAPADeviation/ IncidentAuditingComplaint HandlingChange ControlOOS/OOTSparta Systems Proprietary4The Proven Quality Solution5Company Finance & Purchasing



Regulatory BodiesEQMS: Harmonized Global Processes

Contract Manufacturers & Packagers


500k Global Users700 (+) ImplementationsBest Practice EQMS WorkflowsTop 35 Pharmaceutical companiesTop 13 out of 15 Med Device CompaniesMeets FDA & global regulatory requirementsSparta Systems Proprietary5

Sparta Systems Customers6

Sparta Systems ProprietaryEQMS Value Pillars7

Business ValueProtect Brand Image & Liability

MeasureBrand Valuation

EQMS BenefitReduce Consumer Facing Events

Business ValueReduce Event Cycle TimesEQMS BenefitContinuously Improve Processes

MeasureIncreased Resource Efficiency

EQMS BenefitConnect All Solutions & Processes

Business ValueSingle integrated platformMeasureReduced Technology Costs


Business ValueReduce Global Production ProblemsMeasureReduced Waste Costs

EQMS BenefitPinpoint and Contain Issues

SUPPLY CHAIN MGMTRISK/COMPLIANCE MANAGEMENTSparta Systems ProprietaryReduce Time to Market7

Executive Dashboards

AnalyticsAnalytics: Actionable Insights

Business Insights

Pre-structured Analyses

Finance & PurchasingEQMS Visibility8Company



Regulatory Bodies

Contract Manufacturers & Packagers


Sparta Systems ProprietaryExisting Customer View

Overlay this EQMS system with TrackWise Analytics to provide management with real time quality information and metrics, to allow for faster decision making for remediation of problems and bringing cost saving efficiencies to you entire manufacturing process across the supply chain. Potential problems will be identified earlier in the process, and less costly adjustments can be made. Actions to correct an issue where it is discovered can now be applied globally to prevent it from happening elsewhere in your organization where similar conditions may exist. TrackWise Analytics allow a company to make fact based decisions about production and release of product, saving companies time and money.

The value this system provides (Value Pillars) :IT Efficiency: IT can now consolidate the support of multiple systems and supporting infrastructure into a handful of core strategic systems, of which EQMS is one of. Knowing that ERP is the foundational system for business decisions, TrackWise easily integrates with ERP and other core systems to produce or consume master data, and to provide fact based information and data that can automate processes between these systems.

Operational Efficiency: Consolidating critical processes into a single set of standards means that companies put in place global standard operating procedures (SOPs). This means that everyone in the supply chain is speaking the same language, following proven and repeatable processes when events occur, and actions taken are applied anywhere the same conditions apply. Following a single set of processes eliminates duplication of efforts and different ways of doing things. Results are easily understood by everyone in the organization and decisions are made based on the same set of rules.

Supply Chain: TrackWise allows you to apply the same standards from raw material supplier through distribution of product. Quality events, audits, actions, CAPAs, complaints and changes can now apply collaboration, investigation and actions across the many organizations and divisions involved with your products. Visibility and transparency can now be applied across your supply chain, and the necessary parties can make fact based decisions when event happen.

Risk Analysis: When you have a single quality system, it becomes the single source of truth. With TrackWise Analytics you can now visualize and analyze metrics which will identify trends and areas of risk for your company. Being able to quickly identify the root cause of a problem allows you to not only correct it where it happened, but to evaluate where similar conditions may exist and take action from preventing the problem from happening elsewhere in your organization. The future holds the ability to use predictive analysis to anticipate areas of risk, prior to issues occurring. 89SpeedQuality IntelligenceAddressing the Visibility Challenge:Whats Broken?RoleBusiness QuestionsTodayExecutiveWhat quality events are happening across the global business environment by product, process, region and function?QuarterlyConsumer: Senior ManagerWhats preventing us from shipping product/filling orders?MonthlyConsumer: QA ManagerWhat is the origination of our problems?How deep are our problems?Weekly/ MonthlyConsumer: AuditorWhat is the root cause of our issues and how deep is the issue?How can we be more proactive in managing our product quality? (i.e. SOPs, training, change management)Days/ WeeksMonthly/ QuarterlyAnalystAre there any positive or negative trends that impact product quality (i.e. waste, warranty, recall costs, etc.)Weekly/ MonthlyBusiness NeedsInsights needed for fact-based decisionsCurrent Reporting ParadigmCurrent OutputSelf-service analytics users were 85% more effective in finding the information in the required amount of time. (Aberdeen Group, April 2012)

Companies that inject analytics into their operations show productivity rate and profitability that are 5-6% higher than their peers. (Harvard Business Review, October 2012)VolumeRoleBusiness QuestionsTWAExecutiveWhat quality events are happening across the global business environment by product, process, region and function?Minutes / Hours Consumer: Senior ManagerWhats preventing us from shipping product/filling orders?Minutes / HoursConsumer: QA ManagerWhat is the origination of our problems?How deep are our problems?Minutes / HoursConsumer: AuditorWhat is the root cause of our issues and how deep is the issue?How can we be more proactive in managing our product quality? (i.e. SOPs, training, change management)Minutes / HoursAnalystAre there any positive or negative trends that impact product quality (i.e. waste, warranty, recall costs, etc.)Minutes / HoursSpeed to Insights and Volume of InsightsBusiness NeedsTWA EnabledInsights needed for fact-based decisionsSparta Systems ProprietaryROI Benefits to Quality Management Value Pillar Examples1011From multiple project solutions/data to a single platformAll processes connected to a single data sourceEfficiencies gained from..Platform ConsolidationInfrastructure/HardwareIntegrationDevelopment and SupportOrganizationalEfficiencies Process effectivenessReporting effectivenessAggregated KPIsDistributionNVA effortsMaintenance & SupportHardwareSoftwareData backupUpgrades++Key Reasons to Implement an EQMS IT EfficiencyERP$

Fragmented Pillar Systems


ValuePoint Solution# Quality ProcessesXXSitesSparta Systems ProprietarySparta Systems Proprietary12Key Reasons to Implement an EQMS Operational EfficienciesRoleKey ResponsibilitiesEQMS BenefitExecutiveKPICritical informationReal-time InfoPush Report VisibilityRegulatory AffairsRegulatory filingRisk assessmentSafety/ComplianceVisibilitySignalingTimely reporting to Regulatory BodiesQA ManagerTask prioritizationProblem areasAudit managementContinuous improvementResource efficiencyHolistic Quality managementManufacturing/ OperationsTasks list, completion, and prioritiesOps reportingCritical Issues detectionBusiness rules based workflowVisibility35%Cost of Managing a growing number of RecordsCost of Managing Records TodayCost of Managing Records TodayReducing Number of Records Given 35% Efficiency GainsVSSparta Systems Proprietary12Product Quality and Value directly correlates to BrandAffects brand integrityCorporate ReputationProfitability (market share)Depends on the recall managementKey Reasons to Implement an EQMSBrand Image ProtectionRecent Events and Brand Image13iPhone antenna issues/ Foxconn Labor IssuesB787 Li-Ion Battery FiresICD (defibrillator) recallsMicroscopic design error (Sandy Bridge)

Brand Sentimen