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Published byMerryl Kelley Modified over 9 years ago
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Gordon Fleming EVP & Chief Marketing Officer Life Sciences Update
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Regulatory Compliance Life Sciences Manufacturers Product Quality Concerns Patient Safety & Physician Preference New Product Development Demanding Customer Requirements Continuing Pricing and Margin Pressures Global Consolidation and Alliances Intense Shareholder Pressures Wholesalers Distributors Group Purchasing Org Government Programs Evolving Regulatory Requirements
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Life Sciences Quality Validation Enhancement Compliance
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Validation
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Quality
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Functionality Serialization Packaging & Labels Potency & Formula Enhanced Traceability
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Compliance FDA cGxP FDA CFR 21 Part 11 Cold Chain Management
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QAD Proprietary How We Define Needs and Priorities QAD Customers Competitive Analysis Analysts Research Industry Standards INSIGHT™ QAD PRC Industry Roadmap Customer Requests QAD Field Feedback QAD Support Feedback Product Definition Product Roadmap Vertical Market Collaborative Development Customer Advisory Groups Development Groups Technical Foundation QAD Strategic Steering Committee QAD Product Review Committee 8
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QAD Proprietary 9 AP Credit Packaging Line Pick Pack Ship Trade Compliance Transportation Sales& marketing Invoice AR Fees Rebates Contracts QAD Financials CRM Trade Mgmt Demand Forecast Sales Order Config urator Product Launch PLM Packaging Inventory Mgmt WO/ Repetitive SSM TMS EDI Inbound PO ASN MRO Purchase EAM Supplier ASN EDI Outbound Invoice PO SV Medical Devices Compliance Module Government Enhanced Controls EAM Validation TMSSSM Manufacturing Lean QAD Serialization QM Warehouse SV QAD Serialization EDI Returns Recalls Service Repair DM APM Customers: Distributors/Wholesalers PLM DM APM SV TMS SSM EAM Product Life Cycle Mgmt Demand Mgmt Advanced Pricing Medical Supplier Visualization Transportation Mgmt Service & Support Enterprise Asset Mgmt Customer Relationship Mgmt CRM PIM Product Information Mgt PIM
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QAD Proprietary PLM DM APM SV TMS SSM EAM Product Life Cycle Mgmt Demand Mgmt Advanced Pricing Medical Supplier Visualization Transportation Mgmt Service & Support Enterprise Asset Mgmt Customer Relationship Mgmt CRM CSS Customer Self Service Compliance Module Government Enhanced Controls EAM Validation TMSSSM Warehouse QAD Serialization
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QAD Proprietary 11 Life Science Solutions Roadmap cGMP Compliance Lot Traceability Validation Chargebacks Demand Mgmt Sales Analysis CRF21 Part11 Quality Supply Visibility PIM PLM EAM Transportation Export Serialization/ ePedigree Cold Chain QMS Service & Support CRM Process Maps Analytics Potency Dual UOM Catch Weight Enhanced Batch
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New! QAD Enterprise Applications 2010
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QAD Supply Visualization Supply Chain Portal Quality Performance
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Enterprise Asset Management 12 Compliance FDA cGMP Maintenance Audit compliance (TS, ISO, FDA, etc.)
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Enterprise Asset Management 12 Compliance Equipment Management Machine Maintenance Execution Test Equipment Calibration Reporting
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Trade Management 2.8.2 Browses Collections
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Process Potency Batch Balancing Formulation Traceability
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Joint Development Accelerate Share Benefit
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Serialization Unit Level CA ePedigree Safety
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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
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QAD Serialization Supplier RxASN QAD EA
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Cold Chain Track excursion time Cold chain material & expiration Alert near expiration or expired Expired or quarantine labels Transfer inventory Scrap inventory
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Validation In partnership with Strategic Toolkit Services Methodology
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Project Planning CSVP End User Training Modify User Procedures/Risk Assessment Test Scripts Standard Business Scenarios Review Results Process Modeling Update System Design Reporting & System Extension Specification & Development - Minimal Conversion Preparation and Testing Prototyping/Fit to Business Technical Infrastructure – IQ Execution Hardware & Software Issue Resolution Document Policy Issues Quality Assurance Checkpoint Project Facilitation Acceptance Testing OQ/PQ Executio n/Trace Matrix Cut Over/Data IQ Post Support
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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
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Quality In partnership with Cebos ISO cGxP TS16949
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Life Sciences Edition On Premise On Demand Qualified Simplified Validation
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Qualified Environment
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LS Edition Global Delivery and Support Quickly Add New Sites or New Users Additional Validation Environment Available Flexible Upgrade Time Schedule Strictly Managed Operation Procedures 17 Dedicated Standard Operating Procedures USA Food and Drug Administration Compliant QAD Maintains the Qualified Hardware QAD Maintains the Qualified Operating System QAD Maintains the Application Environments Scalability Business Alignment Operational Control Risk Mitigation
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17 Life Sciences On Demand SOPs SOP on SOPs Training Facility Security Data/ Network Backup Data Archiving Network/ Computer Security Software Installation System Security Reviews System Change Control System Maintenance Recording Disaster Recovery Record Retention Electronic Mail Internal Audits Change Approval Non- Disclosure Issue Tracking
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Brazil
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?
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Riya Cao Director – Life Sciences zrc@qad.com
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