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Microsoft Axapta For Microsoft Axapta For Life SciencesLife Sciences
Mark JensenMark JensenGeneral ManagerGeneral ManagerMicrosoft Business Solutions-AxaptaMicrosoft Business Solutions-Axapta
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AgendaAgenda StrategyStrategy Business DriversBusiness Drivers Positioning and Value PropositionPositioning and Value Proposition Solution OverviewSolution Overview Partner Program and CertificationPartner Program and Certification Readiness and MarketingReadiness and Marketing
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Build & PartnerBuild & Partner
ManufacturingManufacturing Project AccountingProject Accounting DistributionDistribution Enterprise PortalEnterprise Portal HRMHRM
Financial ManagementFinancial ManagementCo
reC
ore
CRMCRM SCMSCM AnalyticsAnalytics
Ve
rtic
alV
ert
ical
Solution Solution DevelopmentDevelopment
Life Sciences ExamplesLife Sciences ExamplesAdverse Event ReportingAdverse Event ReportingWMS (industry specific)WMS (industry specific)Corrective Action/Preventative Action (CAPA)Corrective Action/Preventative Action (CAPA)Laboratory Information Management (LIMS)Laboratory Information Management (LIMS)
MBS DevelopmentMBS Development
ISV/Partner DevelopmentISV/Partner Development
Microsoft Axapta Partner-Led StrategyMicrosoft Axapta Partner-Led Strategy
Apparel & TextileApparel & Textile CPGCPG Industrial Industrial EquipmentEquipment
Process Process ManufacturingManufacturing Life SciencesLife Sciences Wholesale Wholesale
and Distributionand Distribution
Automotive Automotive SuppliersSuppliers ConstructionConstruction High Tech High Tech
and Electronicsand Electronics Metal FabricationMetal Fabrication Professional Professional ServicesServices RetailRetail
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Why a Life Sciences Platform?Why a Life Sciences Platform? Lower barriers to Life Sciences entry for our ISVs Lower barriers to Life Sciences entry for our ISVs
and partnersand partners Complete the MBS overall strategy for the Life Complete the MBS overall strategy for the Life
Sciences marketSciences market Microsoft Axapta Partners focused on Life SciencesMicrosoft Axapta Partners focused on Life Sciences Significant market opportunitySignificant market opportunity Less competitive, more profitable verticalLess competitive, more profitable vertical Partner FeedbackPartner Feedback
ISV’s in this space support the platform ISV’s in this space support the platform approachapproach
Components are not what the ISVs want to Components are not what the ISVs want to developdevelop
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Life Sciences Target ProfileLife Sciences Target Profile
ManufacturersManufacturers DistributorsDistributors
FDA/ICH regulationsFDA/ICH regulations Primary ERP opportunity driver is Primary ERP opportunity driver is
Part 11 compliance requirementsPart 11 compliance requirements More!More! CXOs CXOs VP Quality VP Quality Chief Compliance OfficerChief Compliance Officer
Common Thread Common Thread (and Opportunity (and Opportunity
Driver!)Driver!)
Business Business Decision Decision MakersMakers
Pharmaceuticals – generic, brand Pharmaceuticals – generic, brand name, and over-the counter name, and over-the counter
Medical DevicesMedical Devices BiotechBiotech NutriceuticalsNutriceuticals
ProductsProducts
OrganizationsOrganizations
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New drug development Increase in counterfeiting Mergers and acquisitions Rising health care costs FDA, ICH and other
regulations High Spend: Life
Sciences 11.5% CAGR vs 7% average
Pharmaceuticals spend 5% of revenues on IT vs 3% average for all Manufacturing Source: IDC, 2002
Opportunity Opportunity DriversDrivers
Life Sciences Business Life Sciences Business DriversDrivers
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What is Microsoft Axapta for What is Microsoft Axapta for Life Sciences?Life Sciences?
• Increased control over processesIncreased control over processes• Electronic signaturesElectronic signatures• Validation documentationValidation documentation
Partner Driven ComponentsPartner Driven Components• Compliant implementation servicesCompliant implementation services• Core enhancement to address unique Core enhancement to address unique
needsneeds• Extend solutions such as LIMS, WMS…Extend solutions such as LIMS, WMS…
Three Key ComponentsThree Key Components
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Industry: Life Science Industry: Life Science SIC / NACE code:SIC / NACE code:283-2835 Pharmaceuticals (NACE 244)283-2835 Pharmaceuticals (NACE 244)384 Medical Devices (NACE 331)384 Medical Devices (NACE 331)2836 Biotechnology (sub set of NACE 244)2836 Biotechnology (sub set of NACE 244)
Together with partner or ISV-provided vertical Together with partner or ISV-provided vertical solutions, Microsoft Axapta for Life Sciences solutions, Microsoft Axapta for Life Sciences helps Life Sciences companies in the helps Life Sciences companies in the midmarket and CAS segments manage their midmarket and CAS segments manage their businesses while simplifying FDA validationbusinesses while simplifying FDA validation
Company Size Company Size 100+ Employees100+ Employees
Product PositioningProduct Positioning
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Value PropositionValue Proposition Provides Enterprise Group functionality designed Provides Enterprise Group functionality designed
to be implemented in accordance with the FDA’s to be implemented in accordance with the FDA’s current Good Manufacturing Practices GMP’scurrent Good Manufacturing Practices GMP’s
- - Title 21 of Code of Federal Regulations Part 11Title 21 of Code of Federal Regulations Part 11
- Need for increased system control- Need for increased system control The solution is provided with comprehensive The solution is provided with comprehensive
documentation to simplify the validation processdocumentation to simplify the validation process Reduces time and effort to validate a customized Reduces time and effort to validate a customized
Microsoft Axapta for Life Sciences solution at the Microsoft Axapta for Life Sciences solution at the customer sitecustomer site
Provide documentation to pass FDA validation at Provide documentation to pass FDA validation at a fraction of the cost of developing their own a fraction of the cost of developing their own documentationdocumentation
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ImplementationImplementation
&&
ModificationsModifications
Partner Partner
Vertical module (GMP)Vertical module (GMP)
Microsoft Axapta for Life SciencesMicrosoft Axapta for Life Sciences
Microsoft AxaptaMicrosoft Axapta
Provider:Provider:
PartnerPartner
Microsoft Microsoft Business Business SolutionsSolutions
Deliverables:Deliverables:
PartnerPartner
A Customer Solution OverviewA Customer Solution Overview
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Certification
Certification
Certification Certification Partner will Partner will provide:provide:
Qualification Partner QualificationQualification
Business ModelBusiness Model
Microsoft Business Microsoft Business Solutions will provide:Solutions will provide:
•A Microsoft Axapta A Microsoft Axapta solution that has been solution that has been modified for the modified for the requirements of the requirements of the Life Sciences industryLife Sciences industry
• ComprehensiveComprehensive documentation of the documentation of the solution, to simplify solution, to simplify validationvalidation
•Sales toolboxSales toolbox•Marketing toolboxMarketing toolbox•License distributionLicense distribution•Product SupportProduct Support•Sustained EngineeringSustained Engineering
Microsoft Business Solutions
Customer
Certification Partner
• Qualification of Microsoft Qualification of Microsoft Axapta 3.0 for Life Axapta 3.0 for Life SciencesSciences
• Certification of partnersCertification of partners• Channel buildingChannel building• Consultancy services to Consultancy services to
partnerspartners• Distribution of a vertical Distribution of a vertical
solution to sales and solution to sales and implementation partnersimplementation partners
• Work with Microsoft Work with Microsoft Business Solutions to Business Solutions to execute sales & marketing execute sales & marketing effortsefforts
• Contact customers on the Contact customers on the request of partners. Never request of partners. Never directly. directly.
Microsoft Business Solutions Subsidiary
Sales & Implementation
Partner
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What will the Sales and What will the Sales and Implementation Partner Provide?Implementation Partner Provide?
They will implement and customize They will implement and customize Microsoft Axapta 3.0 for Life Microsoft Axapta 3.0 for Life SciencesSciences and perhaps a Life Sciences-specific vertical solution, to and perhaps a Life Sciences-specific vertical solution, to support the specific business processes of each customer. support the specific business processes of each customer.
The partners are certified, so customers can have confidence that The partners are certified, so customers can have confidence that the partner has the skills and capabilities needed to provide a the partner has the skills and capabilities needed to provide a validated implementationvalidated implementation
NNIT- first Certification partnerNNIT- first Certification partner
• Contact: Phillip RubinoContact: Phillip Rubino
[email protected], +45 3079 9232, +45 3079 9232
Potential partner services:Potential partner services:
• Implementation and customization of Microsoft Axapta 3.0 for Life SciencesImplementation and customization of Microsoft Axapta 3.0 for Life Sciences
• Implementation of Life Sciences-specific verticalsImplementation of Life Sciences-specific verticals
• Validation of complete solutionValidation of complete solution
• Training of end-usersTraining of end-users
• Consultancy services related to defining customers processesConsultancy services related to defining customers processes
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Certification Requirements for the Certification Requirements for the Sales and Implementation Partner:Sales and Implementation Partner:
Quality Management System Quality Management System Quality Assurance unit or roles are definedQuality Assurance unit or roles are defined Standard Operating Procedures for Standard Operating Procedures for
Software developmentSoftware development DeploymentDeployment MaintenanceMaintenance Customer supportCustomer support
Partner’s own IT installations in controlPartner’s own IT installations in control Employee Training Program Employee Training Program Awareness of computer validation requirements in Awareness of computer validation requirements in
the Life Sciences industrythe Life Sciences industry
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NNIT Partner ProgramNNIT Partner ProgramSales & Marketing ProgramSales & Marketing Program
Presales assistance Presales assistance Implementation Validation assistanceImplementation Validation assistance Sales toolboxSales toolbox Sales training in Sales training in
How to sell to the Life Science IndustryHow to sell to the Life Science Industry How to sell Microsoft Axapta for Life ScienceHow to sell Microsoft Axapta for Life Science How to sell the vertical solution for the Life Science IndustryHow to sell the vertical solution for the Life Science Industry
Certification package includes:Certification package includes: Introductory CourseIntroductory Course
Computer validation in the Life Sciences industryComputer validation in the Life Sciences industry Product trainingProduct training
Written guidelines and instructions on validation activitiesWritten guidelines and instructions on validation activities e.g. e.g. Validation PlanningValidation Planning SpecificationsSpecifications Test and verification etc.Test and verification etc.
Generic templates for validation documentation e.g.Generic templates for validation documentation e.g. Validation PlanValidation Plan Installation Qualification ProtocolInstallation Qualification Protocol Performance Qualification Protocol etc.Performance Qualification Protocol etc.
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Certification ProcessCertification Process
Introduction Introduction
Certification audit Certification audit
Remedy issues Remedy issues
TrainingTraining
Computer validation guidelinesComputer validation guidelines
Axapta validation templatesAxapta validation templates
Final assessment Final assessment
Issuance of Issuance of Axapta for Life Sciences CertificateAxapta for Life Sciences Certificate
Time line
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Product ReadinessProduct Readiness Product Release Date: Q1 CY05Product Release Date: Q1 CY05 Initial geographies on price listInitial geographies on price list
US, European Union, Canada, SwitzerlandUS, European Union, Canada, Switzerland
Language versionsLanguage versions The core Microsoft Axapta functionality will be The core Microsoft Axapta functionality will be
available in any of the languages supported by available in any of the languages supported by Microsoft Axapta 3.0 Microsoft Axapta 3.0
However, the additional functionality provided by However, the additional functionality provided by Microsoft Axapta for Life Sciences (electronic Microsoft Axapta for Life Sciences (electronic signature) will be labeled in US English language signature) will be labeled in US English language onlyonly
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Marketing & SupportMarketing & Support Marketing:Marketing:
November 1: Press releaseNovember 1: Press release January timeframe:January timeframe:
Launch paper (marketing white paper)Launch paper (marketing white paper) Story on Microsoft.comStory on Microsoft.com Technical white paperTechnical white paper Life Science council briefingLife Science council briefing Fact SheetFact Sheet Customer BDM & TDM presentationCustomer BDM & TDM presentation
Life Sciences Roadshow – January/February 2005Life Sciences Roadshow – January/February 2005 Case studies (6 months - 1 year after launch)Case studies (6 months - 1 year after launch)
Support:Support: Support for Microsoft Axapta 3.0 for Life Sciences will be Support for Microsoft Axapta 3.0 for Life Sciences will be
provided through Global Technical Support Centres – GTSCprovided through Global Technical Support Centres – GTSC
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DefinitionsDefinitionsFDAFDA Food and Drug Administration. It is the United States governmental
agency responsible for the evaluation and approval of medical devices.
GMPGMP Good Manufacturing Practice (regulation); GMP is a set of regulations requiring that quality, safety, and effectiveness be built into foods, drugs, medical devices, and biological products.
21 CFR Part 1121 CFR Part 11 Title 21 of Code of Federal Regulations Part 11. Regulation issued by FDA regarding use of electronic records and electronic signatures.
Qualification The process of demonstrating whether an entity is capable of fulfilling specified requirements. Ref.: ISO 8402.Qualification of an IT application includes:
• Assessment if the specifications are appropriate for the intended use• Verification that the functionalities actually are in accordance with
specifications
Validation Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Ref.: FDA.
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