Microsoft Business Solutions Axapta

Microsoft Axapta For Life Sciences Mark Jensen General Manager Microsoft Business Solutions-Axapta

Agenda

Strategy

Business Drivers

Positioning and Value Proposition

Solution Overview

Partner Program and Certification

Readiness and Marketing

Microsoft Axapta Partner-Led Strategy Manufacturing Project Accounting Distribution Enterprise Portal HRM Financial Management Core CRM SCM Analytics Vertical Build & Partner Solution Development

Life Sciences Examples

Adverse Event Reporting

WMS (industry specific)

Corrective Action/Preventative Action (CAPA)

Laboratory Information Management (LIMS)

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

Why a Life Sciences Platform?

Lower barriers to Life Sciences entry for our ISVs and partners

Complete the MBS overall strategy for the Life Sciences market

Microsoft Axapta Partners focused on Life Sciences

Significant market opportunity

Less competitive, more profitable vertical

Partner Feedback

ISV’s in this space support the platform approach

Components are not what the ISVs want to develop

Life Sciences Target Profile

Manufacturers

Distributors

FDA/ICH regulations

Primary ERP opportunity driver is Part 11 compliance requirements

More!

CXOs

VP Quality

Chief Compliance Officer

Common Thread (and Opportunity Driver!) Business Decision Makers

Pharmaceuticals – generic, brand name, and over-the counter

Medical Devices

Biotech

Nutriceuticals

Products Organizations

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 Drivers Life Sciences Business Drivers

What is Microsoft Axapta for Life Sciences?

Increased control over processes

Electronic signatures

Validation documentation

Partner Driven Components

Compliant implementation services

Core enhancement to address unique needs

Extend solutions such as LIMS, WMS…

Three Key Components

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

Value Proposition

Provides Enterprise Group functionality designed to be implemented in accordance with the FDA’s current Good Manufacturing Practices GMP’s

- Title 21 of Code of Federal Regulations Part 11

- Need for increased system control

The solution is provided with comprehensive documentation to simplify the validation process

Reduces time and effort to validate a customized Microsoft Axapta for Life Sciences solution at the customer site

Provide documentation to pass FDA validation at a fraction of the cost of developing their own documentation

A Customer Solution Overview Implementation & Modifications Partner Vertical module (GMP) Microsoft Axapta for Life Sciences Microsoft Axapta Provider: Partner Microsoft Business Solutions Deliverables: Partner

Business Model Certification Partner will provide: Qualification Partner Qualification

Microsoft Business Solutions will provide:

A Microsoft Axapta solution that has been modified for the requirements of the Life Sciences industry

Comprehensive documentation of the solution, to simplify validation

Sales toolbox

Marketing toolbox

License distribution

Product Support

Sustained Engineering

Microsoft Business Solutions Customer Certification Partner

Qualification of Microsoft Axapta 3.0 for Life Sciences

Certification of partners

Channel building

Consultancy services to partners

Distribution of a vertical solution to sales and implementation partners

Work with Microsoft Business Solutions to execute sales & marketing efforts

Contact customers on the request of partners. Never directly.

Microsoft Business Solutions Subsidiary Sales & Implementation Partner Certification

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

NNIT- first Certification partner

Contact: Phillip Rubino

[email_address] , +45 3079 9232

Potential partner services:

Implementation and customization of Microsoft Axapta 3.0 for Life Sciences

Implementation of Life Sciences-specific verticals

Validation of complete solution

Training of end-users

Consultancy services related to defining customers processes

Certification Requirements for the Sales and Implementation Partner:

Quality Management System

Quality Assurance unit or roles are defined

Standard Operating Procedures for

Software development

Deployment

Maintenance

Customer support

Partner’s own IT installations in control

Employee Training Program

Awareness of computer validation requirements in the Life Sciences industry

NNIT Partner Program Sales & Marketing Program

Presales assistance

Implementation Validation assistance

Sales toolbox

Sales training in

How to sell to the Life Science Industry

How to sell Microsoft Axapta for Life Science

How to sell the vertical solution for the Life Science Industry

Certification package includes:

Introductory Course

Computer validation in the Life Sciences industry

Product training

Written guidelines and instructions on validation activities e.g.

Validation Planning

Specifications

Test and verification etc.

Generic templates for validation documentation e.g.

Validation Plan

Installation Qualification Protocol

Performance Qualification Protocol etc.

Certification Process

Introduction

Certification audit

Remedy issues

Training

Computer validation guidelines

Axapta validation templates

Final assessment

Issuance of Axapta for Life Sciences Certificate

Time line

Product Readiness

Product Release Date: Q1 CY05

Initial geographies on price list

US, European Union, Canada, Switzerland

Language versions

The core Microsoft Axapta functionality will be available in any of the languages supported by Microsoft Axapta 3.0

However, the additional functionality provided by Microsoft Axapta for Life Sciences (electronic signature) will be labeled in US English language only

Marketing & Support

Marketing:

November 1: Press release

January timeframe:

Launch paper (marketing white paper)

Story on Microsoft.com

Technical white paper

Life Science council briefing

Fact Sheet

Customer BDM & TDM presentation

Life Sciences Roadshow – January/February 2005

Case studies (6 months - 1 year after launch)

Support:

Support for Microsoft Axapta 3.0 for Life Sciences will be provided through Global Technical Support Centres – GTSC

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.

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

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.