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Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
Microsoft Business Solutions Axapta
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Microsoft Business Solutions Axapta

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    • 1. Microsoft Axapta For Life Sciences Mark Jensen General Manager Microsoft Business Solutions-Axapta
    • 2. Agenda <ul><li>Strategy </li></ul><ul><li>Business Drivers </li></ul><ul><li>Positioning and Value Proposition </li></ul><ul><li>Solution Overview </li></ul><ul><li>Partner Program and Certification </li></ul><ul><li>Readiness and Marketing </li></ul>
    • 3. Microsoft Axapta Partner-Led Strategy Manufacturing Project Accounting Distribution Enterprise Portal HRM Financial Management Core CRM SCM Analytics Vertical Build & Partner Solution Development <ul><li>Life Sciences Examples </li></ul><ul><li>Adverse Event Reporting </li></ul><ul><li>WMS (industry specific) </li></ul><ul><li>Corrective Action/Preventative Action (CAPA) </li></ul><ul><li>Laboratory Information Management (LIMS) </li></ul>MBS Development ISV/Partner Development Apparel & Textile CPG Industrial Equipment Process Manufacturing Life Sciences Wholesale and Distribution Automotive Suppliers Construction High Tech and Electronics Metal Fabrication Professional Services Retail
    • 4. Why a Life Sciences Platform? <ul><li>Lower barriers to Life Sciences entry for our ISVs and partners </li></ul><ul><li>Complete the MBS overall strategy for the Life Sciences market </li></ul><ul><li>Microsoft Axapta Partners focused on Life Sciences </li></ul><ul><li>Significant market opportunity </li></ul><ul><li>Less competitive, more profitable vertical </li></ul><ul><li>Partner Feedback </li></ul><ul><ul><li>ISV’s in this space support the platform approach </li></ul></ul><ul><ul><li>Components are not what the ISVs want to develop </li></ul></ul>
    • 5. Life Sciences Target Profile <ul><li>Manufacturers </li></ul><ul><li>Distributors </li></ul><ul><li>FDA/ICH regulations </li></ul><ul><li>Primary ERP opportunity driver is Part 11 compliance requirements </li></ul><ul><li>More! </li></ul><ul><li>CXOs </li></ul><ul><li>VP Quality </li></ul><ul><li>Chief Compliance Officer </li></ul>Common Thread (and Opportunity Driver!) Business Decision Makers <ul><li>Pharmaceuticals – generic, brand name, and over-the counter </li></ul><ul><li>Medical Devices </li></ul><ul><li>Biotech </li></ul><ul><li>Nutriceuticals </li></ul>Products Organizations
    • 6. <ul><li>New drug development </li></ul><ul><li>Increase in counterfeiting </li></ul><ul><li>Mergers and acquisitions </li></ul><ul><li>Rising health care costs </li></ul><ul><li>FDA, ICH and other regulations </li></ul><ul><li>High Spend: Life Sciences 11.5% CAGR vs 7% average </li></ul><ul><li>Pharmaceuticals spend 5% of revenues on IT vs 3% average for all Manufacturing Source: IDC, 2002 </li></ul>Opportunity Drivers Life Sciences Business Drivers
    • 7. What is Microsoft Axapta for Life Sciences? <ul><li>Increased control over processes </li></ul><ul><li>Electronic signatures </li></ul><ul><li>Validation documentation </li></ul><ul><li>Partner Driven Components </li></ul><ul><li>Compliant implementation services </li></ul><ul><li>Core enhancement to address unique needs </li></ul><ul><li>Extend solutions such as LIMS, WMS… </li></ul>Three Key Components
    • 8. Product Positioning Industry: Life Science SIC / NACE code: 283-2835 Pharmaceuticals (NACE 244) 384 Medical Devices (NACE 331) 2836 Biotechnology (sub set of NACE 244) Together with partner or ISV-provided vertical solutions, Microsoft Axapta for Life Sciences helps Life Sciences companies in the midmarket and CAS segments manage their businesses while simplifying FDA validation Company Size 100+ Employees
    • 9. Value Proposition <ul><li>Provides Enterprise Group functionality designed to be implemented in accordance with the FDA’s current Good Manufacturing Practices GMP’s </li></ul><ul><li>-  Title 21 of Code of Federal Regulations Part 11 </li></ul><ul><li>- Need for increased system control </li></ul><ul><li>The solution is provided with comprehensive documentation to simplify the validation process </li></ul><ul><li>Reduces time and effort to validate a customized Microsoft Axapta for Life Sciences solution at the customer site </li></ul><ul><li>Provide documentation to pass FDA validation at a fraction of the cost of developing their own documentation </li></ul>
    • 10. A Customer Solution Overview Implementation & Modifications Partner Vertical module (GMP) Microsoft Axapta for Life Sciences Microsoft Axapta Provider: Partner Microsoft Business Solutions Deliverables: Partner
    • 11. Business Model Certification Partner will provide: Qualification Partner Qualification <ul><li>Microsoft Business Solutions will provide: </li></ul><ul><ul><li>A Microsoft Axapta solution that has been modified for the requirements of the Life Sciences industry </li></ul></ul><ul><ul><li>Comprehensive documentation of the solution, to simplify validation </li></ul></ul><ul><ul><li>Sales toolbox </li></ul></ul><ul><ul><li>Marketing toolbox </li></ul></ul><ul><ul><li>License distribution </li></ul></ul><ul><ul><li>Product Support </li></ul></ul><ul><ul><li>Sustained Engineering </li></ul></ul>Microsoft Business Solutions Customer Certification Partner <ul><li>Qualification of Microsoft Axapta 3.0 for Life Sciences </li></ul><ul><li>Certification of partners </li></ul><ul><li>Channel building </li></ul><ul><li>Consultancy services to partners </li></ul><ul><li>Distribution of a vertical solution to sales and implementation partners </li></ul><ul><li>Work with Microsoft Business Solutions to execute sales & marketing efforts </li></ul><ul><li>Contact customers on the request of partners. Never directly. </li></ul>Microsoft Business Solutions Subsidiary Sales & Implementation Partner Certification
    • 12. What will the Sales and Implementation Partner Provide? They will implement and customize Microsoft Axapta 3.0 for Life Sciences and perhaps a Life Sciences-specific vertical solution, to support the specific business processes of each customer. The partners are certified, so customers can have confidence that the partner has the skills and capabilities needed to provide a validated implementation <ul><li>NNIT- first Certification partner </li></ul><ul><li>Contact: Phillip Rubino </li></ul><ul><ul><ul><li>[email_address] , +45 3079 9232 </li></ul></ul></ul><ul><li>Potential partner services: </li></ul><ul><li>Implementation and customization of Microsoft Axapta 3.0 for Life Sciences </li></ul><ul><li>Implementation of Life Sciences-specific verticals </li></ul><ul><li>Validation of complete solution </li></ul><ul><li>Training of end-users </li></ul><ul><li>Consultancy services related to defining customers processes </li></ul>
    • 13. Certification Requirements for the Sales and Implementation Partner: <ul><li>Quality Management System </li></ul><ul><li>Quality Assurance unit or roles are defined </li></ul><ul><li>Standard Operating Procedures for </li></ul><ul><ul><li>Software development </li></ul></ul><ul><ul><li>Deployment </li></ul></ul><ul><ul><li>Maintenance </li></ul></ul><ul><ul><li>Customer support </li></ul></ul><ul><li>Partner’s own IT installations in control </li></ul><ul><li>Employee Training Program </li></ul><ul><li>Awareness of computer validation requirements in the Life Sciences industry </li></ul>
    • 14. NNIT Partner Program Sales & Marketing Program <ul><li>Presales assistance </li></ul><ul><li>Implementation Validation assistance </li></ul><ul><li>Sales toolbox </li></ul><ul><li>Sales training in </li></ul><ul><ul><li>How to sell to the Life Science Industry </li></ul></ul><ul><ul><li>How to sell Microsoft Axapta for Life Science </li></ul></ul><ul><ul><li>How to sell the vertical solution for the Life Science Industry </li></ul></ul><ul><li>Certification package includes: </li></ul><ul><li>Introductory Course </li></ul><ul><ul><li>Computer validation in the Life Sciences industry </li></ul></ul><ul><ul><li>Product training </li></ul></ul><ul><li>Written guidelines and instructions on validation activities e.g. </li></ul><ul><ul><li>Validation Planning </li></ul></ul><ul><ul><li>Specifications </li></ul></ul><ul><ul><li>Test and verification etc. </li></ul></ul><ul><li>Generic templates for validation documentation e.g. </li></ul><ul><ul><li>Validation Plan </li></ul></ul><ul><ul><li>Installation Qualification Protocol </li></ul></ul><ul><ul><li>Performance Qualification Protocol etc. </li></ul></ul>
    • 15. Certification Process <ul><li>Introduction </li></ul><ul><li>Certification audit </li></ul><ul><li>Remedy issues </li></ul><ul><li>Training </li></ul><ul><li>Computer validation guidelines </li></ul><ul><li>Axapta validation templates </li></ul><ul><li>Final assessment </li></ul><ul><li>Issuance of Axapta for Life Sciences Certificate </li></ul>Time line
    • 16. Product Readiness <ul><li>Product Release Date: Q1 CY05 </li></ul><ul><li>Initial geographies on price list </li></ul><ul><ul><li>US, European Union, Canada, Switzerland </li></ul></ul><ul><li>Language versions </li></ul><ul><ul><li>The core Microsoft Axapta functionality will be available in any of the languages supported by Microsoft Axapta 3.0 </li></ul></ul><ul><ul><li>However, the additional functionality provided by Microsoft Axapta for Life Sciences (electronic signature) will be labeled in US English language only </li></ul></ul>
    • 17. Marketing & Support <ul><li>Marketing: </li></ul><ul><ul><li>November 1: Press release </li></ul></ul><ul><ul><li>January timeframe: </li></ul></ul><ul><ul><ul><li>Launch paper (marketing white paper) </li></ul></ul></ul><ul><ul><ul><li>Story on Microsoft.com </li></ul></ul></ul><ul><ul><ul><li>Technical white paper </li></ul></ul></ul><ul><ul><ul><li>Life Science council briefing </li></ul></ul></ul><ul><ul><ul><li>Fact Sheet </li></ul></ul></ul><ul><ul><ul><li>Customer BDM & TDM presentation </li></ul></ul></ul><ul><ul><li>Life Sciences Roadshow – January/February 2005 </li></ul></ul><ul><ul><li>Case studies (6 months - 1 year after launch) </li></ul></ul><ul><li>Support: </li></ul><ul><ul><li>Support for Microsoft Axapta 3.0 for Life Sciences will be provided through Global Technical Support Centres – GTSC </li></ul></ul>
    • 18. Definitions Food and Drug Administration. It is the United States governmental agency responsible for the evaluation and approval of medical devices. FDA Validation Qualification 21 CFR Part 11 GMP 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. <ul><li>The process of demonstrating whether an entity is capable of fulfilling specified requirements. Ref.: ISO 8402. </li></ul><ul><li>Qualification of an IT application includes: </li></ul><ul><ul><li>Assessment if the specifications are appropriate for the intended use </li></ul></ul><ul><ul><li>Verification that the functionalities actually are in accordance with specifications </li></ul></ul>Title 21 of Code of Federal Regulations Part 11. Regulation issued by FDA regarding use of electronic records and electronic signatures. 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.
    • 19.  

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