During this presentation, Merit Solutions CEO Bill Burke will discuss selling the Microsoft platform into the mid-market pharmaceutical space. After discussing the target market (who, what, where), we will present current business drivers, compliance requirements, and specific terminology for pharmaceutical executives. We will wrap up by presenting the Microsoft platform solution, combining pharmaceutical Quality + ERP + Document Management capabilities in one integrated, cost-effective solution.

1. Bill Burke
CEO
Merit Solutions, Inc.

2. As CEO of Merit Solutions, Bill
has been working with FDA
regulated companies since 2003.
Bill has 24 years’ experience in
leading technology companies
through various stages from
inception through public
capitalization.

3. Microsoft Dynamics AX ISV and Systems Integrator
Microsoft Dynamics AX Industry ISV Solutions
Embedded in Microsoft Dynamics AX and Microsoft
SharePoint

4. Who are the ideal prospects –
and where are they located?
Source: Microsoft.com

5. 17%
79%
Statistics of U.S.
Businesses

7. 2833 Medicinal Chemicals and Botanical Products 3827 Optical Instruments and Lenses
2834 Pharmaceutical Preparations 3841 Surgical and Medical Instruments and Apparatus
2835 In Vitro and In Vivo Diagnostic Substances 3842 Orthopedic, Prosthetic, and Surgical Appliances and Supplies
2836 Biological Products, Except Diagnostic Substances 3843 Dental Equipment and Supplies
2844 Perfumes, Cosmetics, and Other Toilet Preparations 3844 X-Ray Apparatus and Tubes and Related Irradiation Apparatus
3821 Laboratory Apparatus and Furniture 3845 Electromedical and Electrotherapeutic Apparatus
3826 Laboratory Analytical Instruments 3851 Ophthalmic Goods

9. CEO
Director, VP
CFO COO CMO CIO
Quality
Accounting VP Customer
Manager Manufacturing Service
Account
Controller
Executive

10. Risk Mitigation

11. Risk Mitigation Do you have real-time intelligence and automated alerts that enable you to
quickly respond to incidents and make good decisions?
Compliance
Can you proactively adapt to changing FDA and customer requirements? Can
you do this cost-effectively?
Improving
Performance Are you managing your structured (ERP) and unstructured (Word, Excel, PDF)
data in a closed, controlled, and integrated system?
How do you ensure material integrity and system validation?

12. Risk Mitigation Can you conform with specific compliance requirements required by clients
and regional governments? Can you do this cost-effectively?
Compliance
Are you managing your structured (ERP) and unstructured (Word, Excel, PDF)
data in a closed, controlled, and integrated system?
Improving
Performance How much time do you spend managing compliance reporting, and what are
the related costs? Are there gaps in your compliance reporting that you
Reducing would like to eliminate?
Costs
How confident are you in your forecasts and maintaining your margins?

13. Why are Life Sciences companies
currently purchasing new
business systems?

14. expect US economy
49% to improve
expect technology
51% spending to increase
83% expect to increase headcount
are planning to increase their
66% global activity
are planning to raise additional
67% funding
Microsoft.com
2013 Venture View

15. 2012 Year-
End VC Investment Stats – MoneyTree
Source: Microsoft.com

17. 1,720 warning
letters
3,640 recall events
9,288 recalled products
Inspections,
Compliance, Enforcement, and Criminal Investigations
Statistics

18. Source: Microsoft.com

19. Who are we competing against
when we’re selling into mid-
market pharma - and how are we
winning?

20. Spreadsheets & PDFs Functionality sits in
Tier One
separate applications
Incomplete horizontal
Customized solutions Older technology
solutions
THE RESULT: COMPLEX, INCOMPLETE,
AND INFLEXIBLE

21. PERVASIVE INTEROPERABILITY
Quality Document
ERP
Management Management
SYSTEMS VALIDATION AND FDA COMPLIANCE
Mitigate Risk
Improve Save Time
and Manage
Performance and Money
Compliance
POWERFUL AGILE SIMPLE
VALUE PILLARS
Deep functionality for global Systems capable of supporting Ease of use speeds time to value
Pharmaceutical manufacturers growth and adapting to change and reduces cost of ownership

22. Research and Financial
Process Manufacturing Supply Chain Management
Development Management
System Validation
Quality Equipment
Projects General Ledger Electronic Batch Records
Management Maintenance
Clinical Trial Accounts Formula Material Control and Recall Warehouse &
Management Payable Management Management Logistics
Accounts Co-Products & Order
Sales Enhanced Lot Traceability
Receivable By-Products Management
Electronic Signatures
Budgeting,
FEFO Shelf-Life
Marketing Planning & Advanced Serialized Inventory Planning
Management
Forecasting
Invoice & Version Trade
Cost of Quality Corrective and Preventive Action
Billing Management Agreements
Catch Weight / Multi-
Samples
Reporting Dual Unit of LIMS Dimensional
Management
Measure Inventory
Controlled Document Management
FDA Compliance

23. Don’t get caught without a
paddle – these are the
features you NEED to
compete and win.

24. Ensures Repeatability & Consistency
Ensures Software Quality & Production
Readiness
Ensures Software Performs According To
Its INTENDED USE
Decreases The Risk Of The
Manufacturing Problems
Decreases The Expenses Caused By The
Failures In Production
Decreases The Risks Non-Compliance
With cGMP Guidelines

25. Leverages existing ERP data removing
duplicate record keeping and redundant
data entry.
Electronic availability of documents and
procedures—no need for paper printouts.
Full document lifecycle management
capabilities, including automated
workflows, audit trails, full versioning
support and archiving.
Enables compliance with industry and
government regulations, including 21 CFR
Part 11.

26. Reduces time, effort, and costs associated
with manual and paper-based processes.
Integrated quality control and product
safety document management solution for
Batch Records, DMRs, CAPA, SOPs, Audits,
Complaints, GMPs and more!
Enables compliance with industry and
government regulations, including US FDA 21
CFR Part 11.
Reduces cost of ownership with integration
with ERP and Quality Management Solution.

27. Forward and backward traceability for all
material lot / serial numbers.
Streamline and automate product
traceability processes.
Quickly view any material lot and / or
serial number, the status of the material,
and all locations of the material.
Detect exceptions early, and consistently
produce the highest quality products.
Use production data of raw materials and
finished goods to calculate shelf life, shelf
advice, and retesting dates.

28. Generate Adverse Event investigation
with automated workflow and approval
processes and detailed documentation.
Meets regulatory requirements for
closed-loop quality management.
Maintain detailed historical records on
corrective action and preventive action
history.
Track incidents take action to correct
and prevent future occurrences.
Reduces cost of ownership with
integration with document management.

29. Enables compliance with industry and
government regulations, including 21 CFR
Part 11.
Apply preventive controls on changes to
fields or windows.
Setup and manage an unlimited number
of authorized approvers and groups.
Capture and store authorizations
electronically to help save time, eliminate
paperwork, and reduce the risk of errors.
Flexible information capture to capture
only the information required / desired.

30. These are just a few Life Sciences
companies who are using
Microsoft Dynamics AX to
transform their business.

31. SONEXUS HEALTH

34. Bill Burke, CEO
Merit Solutions, Inc.
+1 (630) 614 – 7133
bburke@meritsolutions.com
www.maxlifesoftware.com