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Gordon Fleming EVP & Chief Marketing Officer

Life Sciences Update. Gordon Fleming EVP & Chief Marketing Officer. Regulatory Compliance. New Product Development. Product Quality Concerns . Patient Safety & Physician Preference. Life Sciences Manufacturers. Wholesalers Distributors Group Purchasing Org Government Programs.

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Gordon Fleming EVP & Chief Marketing Officer

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  1. Life Sciences Update Gordon FlemingEVP & Chief Marketing Officer

  2. Regulatory Compliance New Product Development Product Quality Concerns Patient Safety & Physician Preference Life Sciences Manufacturers Wholesalers Distributors Group Purchasing Org Government Programs Demanding Customer Requirements Continuing Pricingand Margin Pressures Global Consolidationand Alliances Intense Shareholder Pressures Evolving Regulatory Requirements

  3. Life Sciences Quality ValidationEnhancementCompliance

  4. Validation

  5. Quality

  6. Functionality • Serialization • Packaging & Labels • Potency & Formula • Enhanced Traceability

  7. Compliance • FDA cGxP • FDA CFR 21 Part 11 • Cold Chain Management

  8. How We Define Needs and Priorities QAD Product Review Committee QAD Strategic Steering Committee QADCustomers VerticalMarket IndustryStandards AnalystsResearch Industry Roadmap ProductRoadmap Product Definition CompetitiveAnalysis INSIGHT™ CustomerRequests QAD Field Feedback QAD SupportFeedback QADPRC CustomerAdvisory Groups Development Groups Technical Foundation Collaborative Development

  9. Medical Devices PIM Product Information Mgt PLM Product Life Cycle Mgmt Customers: Distributors/Wholesalers DM Demand Mgmt PLM Product APM Advanced Pricing Medical Launch PIM EDI EDI EDI SV Supplier Visualization Inbound Outbound CRM PO Invoice Sales & TMS Transportation Mgmt marketing PIM AR Config Trade Service & Support SSM urator Mgmt DM APM Credit Demand QAD EAM Enterprise Asset Mgmt Sales Financials Forecast Fees Contracts Invoice Order AP Rebates Customer Relationship Mgmt CRM WO / Repetitive Lean QAD Service Repair Returns Recalls Serialization Trade Packaging Manufacturing Pick Pack Ship Compliance MRO Transportation EAM SSM Purchase TMS Packaging Line Inventory Supplier ASN PO Mgmt ASN SV EDI SV Warehouse Compliance Enhanced Compliance PIM QAD TMS SSM EAM Validation QM Warehouse Controls Module Serialization Government 9

  10. PLM Product Life Cycle Mgmt DM Demand Mgmt APM Advanced Pricing Medical SV Supplier Visualization TMS Transportation Mgmt Service & Support SSM EAM Enterprise Asset Mgmt Customer Relationship Mgmt CRM Customer Self Service CSS Compliance Enhanced Compliance QAD TMS SSM EAM Validation Warehouse Controls Module Serialization Government

  11. Life Science Solutions Roadmap Potency Dual UOM Catch Weight Enhanced Batch Serialization/ ePedigree Cold Chain QMS PIM PLM EAM Transportation Export Service & Support CRM Process Maps Analytics CRF21 Part11 Quality Supply Visibility Chargebacks Demand Mgmt Sales Analysis cGMP Compliance Lot Traceability Validation

  12. New! • QAD Enterprise Applications2010

  13. QAD Supply VisualizationSupply Chain Portal • Quality Performance

  14. Enterprise Asset Management 12 • Compliance • FDA cGMP Maintenance • Audit compliance • (TS, ISO, FDA, etc.)

  15. Enterprise Asset Management 12 • Compliance • Equipment Management • Machine Maintenance Execution • Test Equipment Calibration • Reporting

  16. Trade Management 2.8.2 • Browses • Collections

  17. Process • Potency • Batch Balancing • FormulationTraceability

  18. Joint Development • AccelerateShareBenefit

  19. Serialization • Unit LevelCA ePedigree • Safety

  20. Serial # range management • Aggregated serialized packaging • Serial control unit/case/shipper/pallet • Label Printing • Serialized Pick/Pack/Ship • Event driven messaging & alerts • Audit trails • RxASN

  21. Supplier RxASN QAD Serialization QAD EA

  22. Cold Chain • Track excursion time • Cold chain material & expiration • Alert near expiration or expired • Expired or quarantine labels • Transfer inventory • Scrap inventory

  23. Validation • In partnership with Strategic • ToolkitServicesMethodology

  24. QualityAssuranceCheckpoint Prototyping/Fit to Business ProcessModeling End User Training Modify User Procedures/Risk Assessment Test Scripts OQ/PQ Execution/Trace Matrix Acceptance Testing PostSupport StandardBusiness Scenarios Cut Over/Data IQ ProjectPlanning CSVP Review Results Update SystemDesign Issue Resolution Document Policy Issues Technical Infrastructure – IQ Execution Hardware & Software Reporting & System Extension Specification & Development - Minimal Conversion Preparation and Testing Project Facilitation

  25. Software Validation Master Plan (SVMP) Development Installation Qualification (IQ) Protocol(s) Development Performance Qualification (PQ) Protocol(s) Development Execution of Installation Qualification (IQ) Protocols Execution of Operational Qualification (OQ) Protocols Execution of Performance Qualification (PQ) Protocols Baseline Configuration Development Stress Test Procedure Development Disaster Recovery Procedure Development Final Validation Report Development 21 CFR Part 11 Compliance Services

  26. Quality • In partnership with Cebos • ISOcGxPTS16949

  27. Life Sciences Edition On PremiseOn DemandQualified Simplified Validation

  28. Qualified Environment

  29. LS Edition • QAD Maintains the Qualified Hardware • QAD Maintains the Qualified Operating System • QAD Maintains the Application Environments • Strictly Managed Operation Procedures • 17 Dedicated Standard Operating Procedures • USA Food and Drug Administration Compliant Scalability Risk Mitigation Operational Control Business Alignment • Additional Validation Environment Available • Flexible Upgrade Time Schedule • Global Delivery and Support • Quickly Add New Sites or New Users

  30. 17 Life Sciences On Demand SOPs Facility Security Data/ Network Backup Training SOP on SOPs Data Archiving Software Installation System Security Reviews Network/ Computer Security Disaster Recovery Record Retention System Maintenance Recording System Change Control Electronic Mail Non- Disclosure Internal Audits Change Approval Issue Tracking

  31. Brazil

  32. ?

  33. Riya Cao Director – Life Sciences zrc@qad.com

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