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News You Can Use — In This Issue

• New Version of Merit Solutions Enterprise Quality Management Software is Available
• Microsoft Convergence 2007 and
  Microsoft Dynamics GP Version 10.0
• How Can Life Sciences Manufacturers Minimize Risk
  in Electronic Processing?
• Tips & Tricks for Customizing Your Dynamics Software
• What Type of Future Articles Would You Like to See?

Merit Solutions announces the second version of its Enterprise Quality Management (EQM) software designed for precision quality control and enforcement. Used together with standard Microsoft Dynamics GP, EQM provides complete testing and tracking of quality results throughout the manufacturing and supply chain processes. With EQM, users can create the highest quality products in the safest and most efficient manner possible.

For users who differentiate on quality, Merit Solutions EQM provides the ability to track test results throughout the life cycle of a process and to activate controls based on test results when used together with Merit Solutions Advanced Lot Management (ALM) and Corrective Action Preventative Action (CAPA). Along with Microsoft Dynamics GP Audit Trails and Electronic Signatures, Merit EQM enables government compliance with FDA 21 CFR Part 11. EQM's functionality ensures quality processes necessary for confident, accurate decision-making.

According to Dan Abernathy, Managing Director at Manufacturing Resource Partners, "With the Merit Solutions Enterprise Quality Management (EQM) module, we can see many more opportunities to use GP Manufacturing to extend process automation efforts. The EQM solution enhances the functionality of Microsoft Dynamics GP by allowing customers to fully automate testing and documentation—all within a single system instead of implementing other applications outside of standard GP. With Merit Solutions' EQM, we can analyze trends and predict challenges ahead of time,
before they snowball into real problems and major issues.
Now that's quality control."

For more information, contact Tim Strudeman at 630-614-7133, x227 or tstrudeman@meritsolutions.com.

Each day, Life Sciences organizations are inundated with a large amount of information to manage related to their customer-facing, manufacturing and supply chain processes. Specific records are required to log every procedure and step involved in customer orders, the procurement of materials and the manufacturing and distribution of each product produced. Previously, all information was captured in unstructured files, such as spreadsheets and word processing documents, and then printed and manually acted upon as paper forms.

Often, these paper forms are required to be tracked and manually transported as the business process is performed to record every verification and approval involved in each activity and step. The use of paper-based processing consumes an excessive amount of resources and time, and introduces other inefficiencies into the organization.

Why go electronic, and what is the risk?

Though ultimately far superior, the transition to and maintenance of electronic business systems have been complicated by government regulations specifying criteria necessary for electronic records to be accepted. These regulations define the parameters by which Life Sciences companies can author, approve, store and distribute such records electronically. Non-compliance could lead to expensive downtime, compromised product quality, regulatory fines and, in the case of fraud, possibly even prison sentences.

How to minimize risk in electronic processing

For Life Sciences companies who meet FDA 21 CFR Part 11 regulations, electronic records and signatures can legally replace their traditional paper counterparts. For companies with high risk, whose products can cause life-or-death situations, quality compliance is an essential government requirement. It is also essential for the production of a
top-quality product.

General industry business software does not meet the needs of Life Sciences companies looking to move to electronic processing. They lack the architecture for tracking and recreating change history according to the regulations and the way auditors will want to see the electronic information. They also lack the controls to support authorized signers and preventative controls that must exist inside the software to enforce business process controls.

Additionally, consulting services firms often lack the knowledge and experience required to deploy business systems in a validated manner in accordance with FDA regulations. When the stakes are high, business systems must be in place that mitigate risk points and ensure proper processing of critical data. To pull everything together swiftly and accurately, specific compliance expertise is essential.

For Life Sciences organizations who are making the move to electronic business systems, Merit Solutions offers pre-built software that meets the specific needs of the Life Sciences industry. Merit Solutions' Life Sciences software meets the common business process needs of Life Sciences companies by providing the architecture necessary to control risk processes and comply with FDA and other regulations.

Merit Solutions offers a proven, repeatable and predictable implementation methodology that ensures rapid deployment of system integration. The implementation methodology is comprised of predesigned FDA validation templates and a process that is easily customizable for individual environments. When additional customization is desired, Merit Solutions' Software Development Services team can offer seamless electronic processing in even the most complex, unique situations. full story here

Companies increasingly look to extend their Dynamics software to meet their unique business process requirements. Many companies now recognize that while the standard software may fit 80% of their business process needs, it can be that last 20% that gives them their competitive advantage.

The good news is that Microsoft Dynamics technologies today make it possible and cost-effective to change the screens, data, and flow of the software. Better yet, changes can be performed in a manner that does not prevent upgrading to new releases. If you are one of these companies, your challenge is to properly prepare for having your software customized to make sure you get what you envisioned, and to ensure that you can upgrade the software going forward. We suggest you consider the following before you move in to customizing your Dynamics software:

1. Is it worth it? Customizing your software will involve consulting cost with (internal or external) experts on the Microsoft Dynamics software. What is the impact on your business of changing or extending the software? Quantify this impact and drive your decision based upon this expected benefit.


2. Can you accomplish it with the standard software? We often have customers request customizations to Dynamics software because they didn't know that the standard software could be configured to accomplish their business process requirements. A small amount of time invested with a senior Dynamics consultant might solve your issue.


3. Document your requirements. Amazingly, many companies embark on customizing software without a baseline of what they are out to accomplish. Your requirements document can be a one hundred page Word document, or a one-page Excel list, but you need to complete the process of gathering and documenting what you expect the customizations to do for you.


4. Have a blueprint. You may feel confident that you understand and envision the changes that need to be made, but it is very important to have these changes specified in a form that is very complete and actionable before embarking on a software development project. We call this a Software Requirements Specification (SRS).
   
   The SRS takes your requirements document and breaks it down to the level of screen shots and English language definitions of the logic that the new software will follow. This is the blueprint of what will be changed or built. When you build a house and change the blueprints in the middle, it adds time, costs and possibly rework. The same is true for software customization. So time spent up-front to do this well reduces a great deal of time and cost later on in the projects. In our software development process, Merit Solutions gathers requirements and creates this blueprint for your review and signature. This is performed as a small, up-front engagement before the significant project is started.
   
5. Trust but verify. It is hard to know what good software development processes should look like if you are not in the software business. At a minimum, they should include the following steps:
   a. Requirements Assessment
   b. Software Requirements Specification
   c. Quality Test Creation (from the SRS)
   d. Coding (from the SRS)
   e. Quality Testing
   f.  Documentation and Packing
   g. Sustained Engineering (Maintenance,
       Support, Upgrades)

In March, Microsoft kicked off its Convergence 2007 conference
for Microsoft Dynamics customers with a vision for increased connectivity within and between organizations.

To empower people across each organization, Microsoft announced new tools, software versions and initiatives designed to help Microsoft Dynamics customers bridge the gap between ideas and the ability to execute them.

To achieve "People-Ready Business," Microsoft is focusing on software that easily integrates with companies' existing systems and is more relevant to the specialized needs of a particular industry.

"Really brought out
the issues clients
face with becoming
SOX compliant."

This quote was written by an attendee of Bill Burke (Merit Solutions) and Randy Pack's (Microsoft) Convergence 2007 breakout presentation entitled "Understand How Microsoft Dynamics GP Can Help You Achieve Your Compliance Objectives."

Their session focused on identifying central concepts surrounding data compliance, including data validation, and security and process integrity requirements for closed-loop controls within financial management and reporting.

Merit Solutions provides software and services to meet the highly regulated needs of Life Sciences and Manufacturing industries and companies requiring Sarbanes-Oxley (SOX) compliance. For
a link to their presentation,
click here.

Other Convergence highlights include the announcement of Microsoft Dynamics GP 10.0, with its new functionality to empower users to work within their everyday applications:

With today's e-mails flooding inboxes at an increasingly rapid pace, we at Merit Solutions want to provide quarterly e-news that is of the highest value in your workplace. Our goal is to achieve the optimal mix of stories featuring news about
Merit Solutions and Microsoft Dynamics software and services, industry-related items and
recent trends.

Who can best help determine the most useful type of news to include? You, our readers, of course! If you have input on the type or scope of articles and specific topics you'd like for us to include, please click here to
e-mail your ideas to Jan Coopman at Merit Solutions. Your feedback is important to us and will help provide the basis of future topics.

Merit Solutions is a leading IT consultancy and software development firm specializing in the Microsoft Dynamics technologies.

Founded in 1999, Merit Solutions helps clients plan their technology investments, design solutions and implement projects that improve business performance. We challenge industry norms by defining business requirements up front and holding ourselves accountable for results through fixed-price commitments.

Directly and through a network of certified channel partners, Merit Solutions offers our own software and Microsoft Dynamics products. In 2006, Merit Solutions entered a licensing agreement and joint development and support contract with Microsoft to distribute Merit Solutions' Electronic Signatures and Audit Trails products as Microsoft products.

Based in the United States near Chicago, Merit Solutions also has locations near San Francisco and in Belgrade, Serbia. We work collaboratively with Microsoft Dynamics Partners throughout North America and worldwide.

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Merit Solutions, Inc.
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Suite 200
Wheaton, IL 60187
(near Chicago)
Phone: 630-614-7133
Fax: 630-614-7141

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For more detailed information about Merit Solutions' products, services, locations and contact information, visit our website at www.meritsolutions.com.