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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

prub@nnit.com, +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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