Merit Matters Blog

Unlike twenty years ago, manufacturers today no longer relinquish responsibility for a product once it is delivered. Now, consumer recalls are weekly occurrences: problems like bacterial contaminations, sterility assurance risks, undeclared ingredients, metal / glass / plastic particles, and oversized tablets have highlighted the need for Life Sciences manufacturers to know exactly where ingredients came from, where they went, and even what machinery they were processed on.

Perhaps this was best summed up by Susan J. Wilkinson, a Smarter Food Supply Networks Subject Matter Expert, with IBM Global Business Services, who wrote “Consumers and governments now hold brand owners fully responsible for everything related to their products,” (FoodLogistics.com, May 2012.)

Here's the bottom line: traceability is an essential aspect of the modern manufacturing environment. Also known as “track and trace,” if it isn't already, traceability should be an integral part of a Life Sciences organization's quality management system.

What does traceability mean?

In its simplest terms, traceability means knowing where a product came from and where it went. It's achieved by giving each unit of production a unique identification code – often a batch or lot number – and logging that through the manufacturing process. Extending the use of these codes to suppliers and customers results in what's often referred to as “one up, one down,” traceability across the supply chain.

Since manufacturers by definition “assemble,” the material or source information has to be linked to the recipe or bill of material. Thus traceability requires an ERP system with the ability to link suppliers, deliveries, and product identification codes to the manufacturing batches and eventual process output.

Regulation and Granularity

In the early days of traceability, lot or batch-level record-keeping was sufficient. However, in many industries, and especially the Life Sciences, a combination of consumer demand and government regulation are driving an increasing level of granularity, down to the individual item.

For an example, look at the Guidance Note on Medical Device Tracking issued by the FDA in January 2010. Addressing the requirements of the Safe Medical Devices and other Acts, this states that “Device tracking is intended to ensure that the Food and Drug Administration (FDA) can require a manufacturer to promptly identify product distribution information and remove a device from the market.”

Traceability and Recalls

When a processing fault or error is discovered, the responsible manufacturer halts production and quarantines goods that might be affected. In many cases though, this is not sufficient to protect the end customer as short lead times and minimal supply chain inventory mean every product is made and shipped as quickly as possible. As a result, if a processing or production problem is discovered the affected goods could be many miles from their origin.

At this point the manufacturer is into a recall situation. All those customers who may have received defective goods have to be contacted and the items recovered. The expense of performing a recall can be huge but easily outweighed by the cost, in terms of reputation damage and lost business, of doing nothing. As a result, many recalls are carried out voluntarily, although agencies such as the FDA have the power to force a recalcitrant manufacturer's hand if necessary.

Importance of Traceability

Traceability lets a manufacturer minimize the size and scope of a recall by providing detailed information about the source, processing and distribution of raw materials and finished goods. The more granular the record-keeping - even down to the discrete item level - the smaller a recall can be. Traceability out to the end-user or customer also helps the manufacturer verify that every affected item has been retrieved, providing a measure of recall effectiveness.

When track and trace thinking is integrated within a single ERP and Quality Management System, an organization can respond quickly, minimizing possible adverse consequences. In turn, this protects the brand, showing that traceability is good for business.

No one chooses to get into a recall situation, but occasionally errors are made. An effective traceability system minimizes negative business impacts while protecting end-users and satisfying regulatory authorities.
Learn about the Top 6 Benefits of Supply Chain Traceability in a Recall Situation.

What are Batch Records?

Batch Records are something every pharmaceutical manufacturer has to deal with – they are the documented history of all the production activities that took place to produce a batch of a product. This includes documentation on when a batch was produced; what raw materials and ingredients were used in the batch; and any quality testing processes and results that were captured during production. The purpose of Batch Records are to define the set of requirements and specifications that will ensure a manufacturer will consistently produce a batch with high quality.

Historically, most Life Sciences companies manage Batch Records separately: they use an ERP system to track their business, and they use a quality management system or manual, paper-based systems to track their batch records. Normally, what this ends up meaning is that the Quality Manager has binders and binders and binders of data in their office with all the paperwork records detailing the production history of all their materials. At best, these binders are scanned into corporate “shared” drives and the company uses monster PDFs as their Batch Records. But it’s all replicated data from their core business system.

In these instances, batch processes are typically slow, redundant, and error prone. Manual processes require additional time for things like printing, sharing, and approving. They require taking the time to copy data from one system to another. And manual processes are also subject to operator discretion, judgment, and interpretation. Unlike you or me, an electronic system will do a programmed task exactly the same way every time. Humans are subject to sleep deprivation, attention lapses, bad attitudes and bad days. While a human production supervisor working in the context of a paper-based system might forget to consult the proper logs of quarantined materials, a properly programmed computer will never make that mistake or never forget to prompt an operator to complete required steps for quality control.

What these Life Sciences companies need is an electronic system that can eliminate the paper-work, optimize manual and redundant processes, and streamline batch production.

What are Electronic Batch Records?

The idea behind an Electronic Batch Record system is simple. You have an ERP system, like Microsoft Dynamics AX, that is giving you an opportunity to record all the details of what it takes to make a product – you’re using the inventory transactions, the production recording transactions, the quality tests and quality orders. The system is tracking ALL of the activity associated with the production of a batch or product. Instead of using a paper-based system, an Electronic Batch Records system simply leverages that data collection engine that is your ERP system and uses it as a system of record to systematically produce a formal Electronic Batch Record or Master Batch Record showing all the materials, activities, and processes that went into producing a product.

Electronic Batch Records provide a way to automatically compile batch production data into a commonly formatted document that will replace paper records and keep track of everything that has affected the batch. Leading EBR systems integrate production, quality control, and product safety document management process to include data from processes and equipment used, raw materials consumed, quality data and test results, deviations and non-conformances, electronic signatures, and more! They also feature complete electronic document management capabilities, including automated workflows, audit trails, and full versioning support that would enable compliance with FDA 21 CFR Part 11 regulations.

Why are Electronic Batch Records important?

Electronic Batch Records help pharmaceutical companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving quality and efficiency. They also help reduce error rates and operating costs, facilitate much quicker throughput, and provide a much higher degree of reliability, such so that when the FDA comes in and wants to see an example of your batch records to audit the accuracy and the effectiveness of your batch record system – there is an automated and electronic system in place that enforces all of those quality and compliance standards.

Learn more about the benefits of Electronic Batch Records in our blog article: Top 7 Benefits of Electronic Batch Records.

Merit Solutions, Inc., announced today that they have signed a reseller agreement for MAXLife ERP software with McGladrey LLP, the largest U.S. provider of assurance, tax and consulting services focused on the middle market. The signing of this agreement will enable McGladrey LLP to provide clients in the BioTech, BioMed, Medical Device, and Pharmaceutical industries with the leading Life Sciences ERP software solution built on Microsoft Dynamics AX.

“McGladrey is committed to providing clients with the most comprehensive life sciences quality and compliance management capabilities for Microsoft Dynamics AX,” said Bob Bell, director of Microsoft Dynamics AX practice with McGladrey LLP. "The industry-specific improvements offered by MAXLife is going to transform the way our clients maintain product quality and regulatory compliance. Our customers are going to be able to overcome stringent industry challenges, such as, 21 CFR Part 11 Compliance, CAPA, Electronic Batch Records, System Validation, and more, to sustain profitability and growth. This announcement strengthens the value we can provide to the life sciences industry and will further enable McGladrey clients to maximize the ROI from their technology investments.”

MAXLife ERP is based on Microsoft’s most advanced and feature-rich ERP system, Microsoft Dynamics AX, and extends the solution to help life sciences companies improve product quality and safety, reduce organizational risk, and maintain FDA compliance. By using MAXLife ERP, life sciences companies can automate, grow, and transform their business with innovative, high quality business process and IT consulting services designed specifically for FDA Regulated companies.

MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint for use by life sciences companies in the following areas:

• Electronic Batch Records
• Quality Document Management
• Enhanced Audit Trails and Electronic Signatures for 21 CFR Part 11 Compliance
• Corrective and Preventive Action (CAPA) Incident Management
• Material Control and Recall Management (Lot Traceability)
• Training and Certification Management (Learning Management)
• System Validation
• Enhanced Approval Controls and Quality Orders
• and more!

"McGladrey is an exciting partnership opportunity for MAXLife, and a welcome addition to our global network of top performing, vertically focused Microsoft Dynamics AX resellers," said Bill Burke, CEO of Merit Solutions. "The McGladrey team brings a wealth of knowledge and experience to our partnership network and we believe their clients will benefit tremendously from our life sciences ERP Software technology. This alliance strengthens our global reach and further exhibits MAXLife’s momentum as the industry-leading Life Sciences ERP solution for Microsoft Dynamics AX. Merit Solutions looks forward to further supporting high quality partners such as McGladrey as we continue to grow and expand."

About McGladrey Technology Consulting
McGladrey understands how people, processes and technology interact to ensure organizational effectiveness. By combining technical expertise and business savvy with a full scope of IT services, McGladrey can assess complex situations, and devise and implement effective solutions quickly and cost effectively. For more information, visit www.mcgladrey.com/technology, join the McGladrey Technology Consulting Facebook fan page, follow us on Twitter @McGladreyTech, @McGladreyERP, @McGladreyCRM, and/or connect with us on YouTube.

About McGladrey
McGladrey LLP is the leading U.S. provider of assurance, tax and consulting services focused on the middle market, with more than 6,500 people in 75 offices nationwide. McGladrey is a licensed CPA firm and serves clients around the world through RSM International, a global network of independent assurance, tax and consulting firms. McGladrey uses its deep understanding of the needs and aspirations of clients to help them succeed. For more information like us on Facebook at McGladrey News, follow us on Twitter @McGladrey and/or connect with us on LinkedIn.

About MAXLife ERP
MAXLife ERP addresses the industry-specific needs of Life Sciences companies that produce FDA regulated products. Unlike other ERP systems, MAXLife is an end-to-end solution that addresses a Life Sciences company’s biggest challenge: quality management. MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint enables quality control and quality assurance processes to work together as part of the business system, and to be transparently available for reviewing and reporting. With MAXLife ERP, Life Sciences companies can track product quality, proactively see and respond to manufacturing variability, meet GMPs, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

MAXLife ERP has passed the Software Solution Test for Microsoft Dynamics AX, which is a major requirement for Certified for Microsoft Dynamics® (CfMD) status.

Today’s business management solutions, particularly enterprise resource planning (ERP) solutions, are evolving from a focus on transactions and data entry to one that places people and usability at the center of solution design. This includes attention to varying work styles, role-based perspectives on information and tasks, and the need to extract information in the context of business processes. This shift is being driven by workers’ dissatisfaction with rigid solutions that fail to integrate cross-business processes; adapt to changing global markets; or address the needs of individuals in different kinds of jobs. This inflexibility results in poor usability, both for the individual worker and for the solution’s fit with company-wide business processes and requirements.

According to the Forrester Research study, The Dynamic Business Applications Imperative, there is a shift toward “Dynamic Business Applications” that is helping to address this challenge. Dynamic business applications are designed for people; they greatly enhance usability and accommodate business agility to help organizations capture the full benefits of their solution. This design-for-people approach places the workers’ contextual tasks at the center of the application’s interface. The tasks, or work, are the basis for all transactions, business processes, collaboration efforts, and tools. Transactional processing and performance are still relevant, but people become the most important element of the solution.

Microsoft Dynamics AX is a leading example of a business management solution designed to optimize usability, improve user productivity, and meet the needs of people in a variety of roles to drive business success. The solution’s user-friendly navigation, familiar interface, visualization aids, and self-service business intelligence (BI) tools are prime examples of highly usable features that are designed for the people who use them.

A solution that’s accessible and relevant to a variety of people can contribute significantly to business success. Although the usability of a business management solution is only one aspect of productivity, it is critical because it can constrain or magnify all other productivity benefits of the solution.

Almost twenty-five years ago a well-known beverage manufacturer discovered traces of benzene in a sample of its product. A worldwide recall was quickly launched - but the firestorm of publicity devastated sales, profits slumped, and after two years the company was bought out by a competitor.

Supply chain traceability technology has advanced dramatically since that time and manufacturers have many more tools at their disposal. This hasn't driven the risk of an adverse event or non-conformance incident to zero, but it has given businesses the ability to respond quickly and effectively.

An overview of Supply Chain Traceability

Let’s consider the pharmaceutical industry for a second. With an estimated market size of $300 billion in annual sales, there is a very large monetary opportunity for sophisticated drug counterfeiters. In fact, drug counterfeiting has increased sixfold over the past decade. Some industry executives believe that 10% of all drugs on the market are fake “knock-offs”; that number can increase up to 50% in poorer regions and countries. In an effort to ensure consumer safety and keep as many counterfeit drugs off the market, government agencies, partners, and consumers alike are continuously increasing their already stringent traceability requirements.

The increasing demands for regulation and easy access to real-time data have made traceability programs and systems a necessity for any Life Sciences manufacturing and distribution company. Traceability is the core of most global regulations. Two concepts underpin traceability; data retention should be “one up, one down”, and every product should have a known and documented “pedigree”.

The capability to track a product using the “one up and one down rule” combines collecting appropriate information about both the source of raw materials or ingredients and their destination, organizing the information, and retrieving it as required. Linking that source data to specific, identifiable units of production within your own manufacturing operation creates a “pedigree” for each batch, lot, case or carton. Connect that to the distribution network and it's possible to determine not only when and where a particular item in a store or warehouse was manufactured, but also when its component / ingredients were produced, where they came from, and what people, processes, and technology they touched.

Benefits of Supply Chain Traceability in a Recall Situation

Life Sciences product recalls are not predictable - they can happen at any time. At any given moment, companies must be able to quickly and effectively recall products that have been deemed unsafe for the market. How a company responds to these situations is critical: failure to handle a recall successfully (either voluntary or mandatory) can have serious economic and legal consequences. With the ever increasing levels of press and public backlash associated with consumer safety and product recalls, it is becoming even more important for FDA-regulated companies to have preventative tools and controls in place to ensure safety, monitor quality, measure the potential impact of any quality incidents, and quickly and effectively perform investigations and recalls.

A well-constructed Life Sciences ERP traceability system can be a tremendous asset in such circumstances. Here's how:

1. Minimize recall size: Since it's clear what product is at risk, where it went, and when, it's possible to go straight to the distributors and even retailers carrying the affected product. This keeps both the costs and visibility of the recall low.
2. Respond quickly: Information can come from many sources. A supplier may detect a problem after the event, a customer could find a defective product, or internal process monitoring, control and inspection activities might unearth an issue. (“Bi-directional” traceability makes it possible to work through the supply chain in either direction.) The linkage with ERP through recipes and formulas, supplier information, and customers makes it possible to retrieve “pedigree” information rapidly and to know where the affected product went. This can be pulled up as actionable data for those working on the recall.
3. Data integrity: Traceability systems that are an integrated component of your ERP systems – connecting multiple departments along the supply chain, including sales, production, quality, and distribution - reduces keying errors and generates reliable data. This minimizes uncertainty and confusion during a recall, and helps to reduce its scope and scale. It also ensures there's data to know when every at-risk product has been recalled.
4. Maintain customer trust and confidence: An aura of competence is created when a manufacturer is clear about what lot numbers, batches, or distribution outlets are affected. This reassures customers that the situation is under control and there's no risk to them.
5. Data for liability claim protection: Effective traceability forms the basis of systems that ensure every at-risk item is removed from shelves, protecting a company against claims of negligence. And don't overlook that an effective traceability system is actually a way to build competitive advantage since it lets a company respond quicker and more effectively than can less far-sighted competitors.
6. Pain reduction: Reporting on the benzene contamination recall in May 1990, the LA Times noted that, “the costs associated with the recent recall… result[ed] in a 75% plunge in earnings for 1989.” It's not possible to say with any certainty that a modern traceability system would have lessened the costs, but given the tools now available, it seems reasonable to believe so. Should your business ever be involved in a recall, effective traceability will lessen the pain.

A recall can be devastating to a business. Rapid, accurate response is essential when the risks to brand equity and reputation are so high.

This is not to say that all Life Sciences companies must have end-to-end Life Sciences ERP or recall management systems. In fact, there are more companies running on spreadsheets and manual paper processes than on industry-specific ERP. However, as these companies grow, as their business processes and supply chains become more complex, as customers become more demanding, and as regulatory compliance becomes increasingly stringent - it will become more difficult for these companies to manage the two key requirements for a good recall process: recall accuracy and response time.

MAXLife ERP and its Materials Control Workbench streamline and automate the recall process, enabling companies to not only perform effective product recalls, but to provide concrete documentation and proof that your company followed all FDA recall procedures. By using MAXLife ERP, companies are given full transparency into the recall process, allowing them to better track the status of a recall, confirm that all of the recalled product was pulled, and quickly notify the customers affected by the recall.

We recently asked the CEO of a large multinational organization why they were changing their ERP system. “To improve our business processes,” he replied, stating one of the most widespread drivers companies have to change their ERP systems. As you evaluate your ERP system with regard to business processes you should first assess the level to which any bad business processes are forced on you by your ERP system; and then identify the number of disparate and sidebar systems users have created to work around your ERP. If you find significant process issues in these areas, a change to a modern ERP system that can help you differentiate your business may be beneficial to your organization.

The functionality and capabilities inherent in your ERP software have a big impact on your business processes. As you assess the effectiveness of your current system, you must first review your core business processes to determine if they enable maximum efficiency and productivity. If they do not, investigate whether the software system imposes constraints on your processes. Are your users saying “I do this because that’s the way the system makes me do it”?

When ERP systems were introduced 20 years ago, they were rigid in their functionality. They forced companies to conform business processes to the dictates of the software, or required them to significantly customize the software to meet their specific requirements. However, business processes evolve over time while the software remains static. This causes a disparity between the way the software was originally implemented and the new requirements of the business. This evolution continues until you get to the point that the processes in the system actually constrict the ability of users to efficiently run your business. In common with the CEO mentioned above, this is a major reason why your company might end up implementing a newer, innovative, and proactive ERP system.

New enterprise ERP software applications like Microsoft Dynamics AX offer flexible business processes based on best practices and process tools such as workflow. Workflow is the ability to set up and change process flows within the system. It includes many capabilities such as electronic routing
of documents, event notification, and automated processes based on triggers. Many ERP vendors offer flexible rules-based workflows
that allow businesses to create custom processes based on their operations. These workflows can be changed as their preferences and requirements evolve. In some of the more sophisticated systems, power users are even able to diagram and implement new workflows with drag-and-drop technology. Such flexibility allows the ERP system to evolve with changes in business processes and practices in your company and industry.

As you assess the effect of your current ERP software on your business processes, you should consider the following questions:

• Do your current business processes decrease efficiency and productivity?
• Are they in place to make up for inefficiencies in the ERP system?
• Have they been dictated by the system because of lack of functionality?
• Have your business requirements changed over the years making the reasons you selected your current system no longer valid?
• Have users created many sidebar and workaround systems outside the ERP?
  

Implementation of a flexible ERP system like allows your company to take advantage of new capabilities, functionality, and fresh ideas. An implementation partner that understands business process optimization and is industry expert is an excellent resource for efficiently implementing the system and effectively setting up your business processes. Selection and implementation of a modern ERP system can reduce manual processes, eliminate redundancy, and reduce paper documentation giving your company the opportunity to:

• Review all business processes in place and determine which are required, which can be modified, and which can be eliminated.
• Identify and eliminate redundancy and manual data entry.
  
• Standardize business processes across all departments.
• Adopt the best practices available in new software to obtain greater efficiency over the current ways of doing business.
• Make use of flexible workflow functionality to take advantage of automated business processes, document routing, events, and alerts.

All businesses at one time or another have to weigh the costs and benefits of retaining an older ERP system against the costs and benefits of selecting and implementing a new one. Legacy systems, although on older technology, provide companies a level of comfort—comfort that is likely at the sacrifice of increased relevant functionality and technology.

The Pharmaceutical industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to inventory, manufacturing, and supply chain management business processes – many Pharmaceutical companies still find themselves buried in paper.

While regulatory reporting and compliance requirements historically drove these organizations to work manually with paper, there have been many advancements in software technology that should be too compelling to ignore. Unfortunately, once manual and paper-based systems are in place, executives tend to stay with these systems in order to stick with their “tried and true” ways of working. And once they are awash in paper, these companies are so consumed in managing paper trails that they cease to see how crippled their operations really are.

By maintaining the status quo, these Pharmaceutical companies are ignoring the significant cost savings, efficiencies, and competitive advantages that electronic systems can provide.

The obvious challenges with historical paper-based processes are that they take a great deal of time, effort, and space to manage and maintain. Then take into consideration the added risk of human errors, overlooked requirements, and forgotten processes. And don’t forget about the raw materials and finished products sitting in the warehouse waiting for manual and paper-based processes to be completed. This represents tied up working capital and fewer inventory turns. All of this adds up to higher costs and lost profits.

Executives who recognize these challenges are refocusing their efforts in order to eliminate the paperwork and automate manual processes. They are looking for an electronic way to efficiently document any procedure, process, transaction, journal, COA, formula or recipe in a way that is compliant with 21 CFR Part 11 Regulations. This means they need built-in full document lifecycle capabilities, complete with automated workflows, audit trails, electronic signatures, approvals, versioning, and archiving. And they need all of this without paper printouts.

Today’s industry leaders that are improving performance in these areas are doing so with Electronic Batch Records (EBRs). Electronic Batch Records help Pharmaceutical companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

Here are the top 7 benefits of Electronic Batch Records (EBRs) ERP Software:

• Improve accuracy and consistency - Unlike humans, an automated Electronic Batch Record system will do a programmed task exactly the same way every time. Humans have moods and are subject to sleep deprivation, attention lapses, bad attitudes and bad days. Automated systems do not, and perform the same way each and every time.
• Increase productivity - The most important driving force for a company's business success is its people. By providing employees with a familiar interface that quickly connects internal people - and even external business partners - to the right information and tools to work faster and smarter, companies can set the stage for increased productivity. Electronic Batch Records also eliminate time-consuming and error-prone data re-entry resulting from multiple, disparate, and paper-based systems.
• Reduce cycle times - A typical pharmaceutical manufacturing cycle time falls somewhere in the 30- to 90-day range, with batch releases alone taking upwards of 60 days. These cycle times typically double in nonconformance scenarios. Electronic Batch Records enforce the consistent execution of manufacturing steps while providing an accurate, real-time view of process and deviation data. The time associated with detecting, tracing, resolving, correcting, and documenting deviations in the manufacturing process within various paper documents is virtually eliminated.
• Reduce Compliance Costs - Compliance requires capturing information, accurately, organizing and retaining the information and quickly and efficiently analyzing and presenting it. This requires processes and procedures that are an integrated part of a company’s way of doing business. Electronic Batch Records systems help Life Sciences companies operate and manufacture products in a consistent and compliant manner.
• Reduce Operating Costs - The biggest cost of manual processes is people. It costs companies time (money) by manually performing tasks that can and should be automated and streamlined by technology. Automated systems also reduce the risk of human errors, which can result in redundant processes, rework, or even audits. Electronic Batch Records also eliminate the large costs associated with printing, reviewing, storing and retrieving paper documents.
• Increase Ability to Scale Rapidly - The idea we discuss with Pharmaceutical companies today is growing with muscle, not fat. When you grow, you have increased volumes going through your business processes, and variations in those processes based on different types of customers, orders, products, suppliers, etc. The disorganization potential of paper-based business systems is far more dangerous and prohibitive to a rapidly growing company.
• Improve Decision Making - Manual and paper-based processes store data in a disconnected and difficult-to-access manner. If data related to these manual processes is required for decision making, there is often a time delay in getting the data into a consistent, usable format. And because it is costly to gather the data, many companies decide to operate without it, which leads to decisions that are less optimal and often time delayed.

Make no mistake: the transition to paperless manufacturing (moving from paper batch records to electronic batch records) can be challenging. Employee pushback, systems validation, and incomplete or inadequate identification of requirements can put your systems and processes at a higher risk of failure. However, the competitive advantages and benefits offered by the use of Electronic Batch Records in modern pharmaceutical manufacturing are real, significant, and too compelling to ignore. When properly implemented and integrated with a Pharmaceutical ERP system, Electronic Batch Records can help companies increase profitability and maintain a competitive advantage.

MAXLife Electronic Batch Records (EBR) eliminates costly paperwork errors, speeds up information distribution and collaboration, and enables strategies for improving quality and efficiency. MAXLife makes it easier for Life Sciences companies to access and track batch records, model and change complex processes, and speed time-to-market.

Merit Solutions believes that many organizations are at a point of profound transformation that won’t be sufficiently addressed via a patchwork of business solutions. That's why we are committed to helping your business be ready for what’s next with the most comprehensive range of integrated solutions today and the most complete vision for the future.

Empowering Your People

For your people, we offer an unparalleled range of integrated, connected solutions that help provide a seamless experience across people’s personal work lives. Our approach is to deliver solutions that are integrated by design across devices and services. From productivity, collaboration, and business apps, to devices and security, our goal is to deliver a connected experience that works together seamlessly and naturally, the way people expect it to work. The result? Get more done, faster, without limits.

We live in an amazing time for technology. At home, when we use our personal devices, we’ve become accustomed to a highly connected experience where all of our apps and information are at our fingertips and the experience has become highly intuitive. It’s easy to watch movies, read books, play games, and share photos and documents. We also know that people consume information in a different way depending on the device they are using—tablets, PCs, or even business whiteboards. In each case, the Microsoft business platform makes it easy to personalize the experience and get it just right. By choosing the Microsoft platform, your company's devices and applications will truly work together - and these connected devices will give you the same version of the truth regardless of the device you are using.

Maximizing IT Flexibility

Our IT customers are entering a new era - a new era for the way they manage and deploy applications and devices. Between the consumerization of IT and the move to the cloud, a lot of what IT provided, from deployment to systems integration, is being radically revised and simplified. Throughout this transformation, we are here to help our customers maximize the return on your IT existing investment and best position you for the future. Our goal is to enable people to use the devices they want to use in the places they want to work - while also enabling enterprises to protect corporate information.

At the same time, we know that you will have more than just Microsoft solutions in your business, and so we are experienced at building bridges across technology. We believe this builds choice, drives innovation, and creates opportunities.

Accelerating your Business

Finally, we’re committed to helping you maximize the return on your investments in Microsoft solutions. Whether that means saving money, growing revenue, attracting and retaining customers, or driving innovation.

In today’s business climate, people expect the technology they use at work to be as simple as the technology they use at home. Today’s technology is expanding the possibilities for connecting people and helping businesses be more proactive and dynamic to change. For example…

• Across your business, we can help you foster a culture of innovation with a connected supply chain platform that embraces today’s social trends and makes it easier for people to communicate, whether through text, voice, or video.
• We can also help you maximize business performance with technology that enables people to make smarter, faster decisions with democratized business analytics tools and the power of big data. And this same technology can also help you reduce costs.

In summary, Merit Solutions offers companies an unparalleled experience across today’s devices, while maximizing IT flexibility and providing the business platform and process optimization services that can truly accelerate your business.

Please comment below if you have any questions or comments as we’d certainly like to continue this conversation and find more ways that we can continue to help companies differentiate their business.

Based on reports from industry analysts and the many conversations that our team has with clients, we believe four megatrends will radically change how businesses view enterprise IT over the coming decade.

• Mobility and social are the driving forces for change in business today, particularly as employees (and customers) increasingly expect to use mobile and social technology to interact in new ways. These two elements are becoming a competitive differentiator for business - for recruiting and retaining employees and for attracting and retaining customers.
• The cloud and big data are quickly becoming enablers for business success. The tremendous scalability and agility enabled by the cloud and the new insights made possible with big data can help businesses today get ahead of the competition and tap into new sources of revenue.

These trends represent not only what is most important to our customers today, but also what we feel are likely to be the dominant forces of change in the coming decade.

• The proliferation of new device types, along with the connectivity of the cloud, is making us more mobile and changing the way we work and play. Mobility answers the growing expectation from your employees to be able to work from anywhere, with the device that they choose. Mobile technology also delivers a great mobile experience to customers, bringing your business to them wherever they are through their mobile phone or tablet.
• As technology becomes more immersive, we also expect it to help us develop more personal and social connections with our colleagues and customers. Social networks build strong work communities, enhancing collaboration, information sharing, and productivity.
• The connectivity that the cloud offers is changing what we expect from technology. With an always-on connection, apps can provide innovative new services with instant scalability and attractive economics.
• While business intelligence (BI) has been important for a great number of years, the explosion in connected devices and apps is generating an exponential growth in data and the need to get better insights from “big data.” The challenge for today’s businesses is to make that data useful—to put it into the hands of their people to drive informed, forward-thinking decisions.

We’re not alone in identifying these megatrends. According to IDC, “In 2012, the ICT industry's shift to its third major platform of growth—built on mobile, cloud, social, and big data technologies—will accelerate.” In contrast to what IDC refers to as the first (mainframe) and second (PC/server) platforms, they estimate that by 2020, “…enterprises’ highest-value leverage of IT will be driven by these third-platform technologies as well as an explosion of new solutions built on the new platform and rapidly expanding consumption of all of the above in emerging markets.”

It’s amazing just how fast our world is changing today. Just think…

• Within 15 years, a little startup named Amazon has gone from transforming the book industry to changing the face of retail.
• It took radio 38 years to reach 50 million users. In less than nine months, Facebook reached 100 million users. And in the space of just a few short years, social networking services have significantly changed people’s expectations of how we interact with each other and with businesses, particularly for the millennial generation.
• Within just two months of its launch, Kinect for the Xbox 360 changed the face of gaming and became the world’s fastest-selling consumer electronics device ever.

Each of these examples reflects the tremendous impact that the megatrends are having on our world - and the pace at which it is all changing. As we enter this new era in the enterprise, the question is - what can your business do to make the most of it?

Of course, technology trends on their own aren’t going to revolutionize your business or help you stay competitive. How you adopt new technology and put it to work in your business will ultimately be the responsibility of IT. We know how important it is to ensure that your technology solutions truly empower your IT professionals to deliver what the business needs. What are those needs?

• Integrate new devices and applications with their existing line-of-business apps, for a seamless experience that keeps people productive and connected to the business.
• Help maximize end user productivity, with solutions that put the tools users need at their fingertips, wherever they happen to be working from, and that connect them with the people, information, and content they rely on to do their jobs well.
• Ensure that corporate data and resources are protected and secure, even as access to those data and resources becomes possible from an increasing number of devices and apps.
• Fully manage all devices on the network, both local and remote - a task that is becoming ever more complicated as users bring more and more devices into the enterprise and work from more and more locations.

At Merit Solutions, our goal is to deliver ground-breaking technology solutions that empower IT to take advantage of the latest trends without compromise. By achieving this goal, we are able to provide your IT professionals with the tools they need to help you innovate and compete while meeting the core needs of the business in all new ways.

Learn more about how Merit Solutions can help you transform your business!

A while back we discussed some global business and IT trends that are slowly but steadily reshaping the ERP landscape. With our emerging economic climate, these trends are posing additional challenges for business and IT professionals who are struggling to improve profitability and retain IT agility.

Global market trends are creating the need for businesses to:

• Achieve operational insight and better decision making across the organization with faster, easier, and more pervasive access to relevant business information.
  
• Need for business agility to stay ahead of the competition and accelerate business growth.
• Reducing the cost of doing business by optimizing processes and driving productivity.
• Align business objectives with IT priorities and investments to ensure that IT systems and tools are enabling and supporting strategic business priorities and that they address changing business needs.

At the same time, shifting IT trends are creating the need to:

• Increase ERP adoption and access to ERP data across a broader subset of the workforce.
• Reduce IT operational costs by investing in systems that are more flexible and scalable, and simpler to configure, maintain, and upgrade.
  
• Put solutions in place that enable broad business strategies, and that enable IT to respond quickly to specific line-of-business (LOB) requests and industry needs.

When you frame this discussion with the research conducted by Forrester in 2010 detailed in our article, Key Challenges Companies Face with ERP Solutions, you can see how the needs produced by market and IT trends are affecting customers’ expectations of their ERP application.

Today’s world is increasingly flattened by technology, global complexity and new global competition - making it critical for a business to be able to rapidly see and react to signals, threats and opportunities. Going one step further, in this world where the pace of business accelerates, imagine being able to anticipate rather than react to those signals. Success today and tomorrow increasingly depends on information insight and efficient business processes.

So what would the next generation of ERP look like? See for yourself!

Nenad Simeunovic, Vice President of Services for Merit Solutions, was recently featured in the PM Network's March 2013 issue discussing using Agile Project Management techniques for ERP implementations.

Here a short excerpt from the article, titled Big Delivery in Small Packages:

Eliminating Waste: Agile is based on lean processes that remove non-value-added activities such as downtime. As a result, agile components such as daily stand-up meetings can help project teams deliver ERP-related functionalities faster. "During the 15-minute meeting, each team member says, 'This is what I did yesterday, this is what I'm going to do today and these are the obstacles I need help with,'" says Nenad Simeunovic, vice president of services at global IT services company Merit Solutions, Wheaton, Illinois, USA. "If there's a challenge, we can address it on the spot and move on. As a result, there are fewer distractions, and progress is being made on a more consistent basis."

Agile's benefits are especially appealing in the current volatile economy. "The departments are reluctant to tackle large-scale projects as one big initiative with scope, time and resources locked. Instead, they are looking more to deliver functionalities in iterations, where flexibility is allowed - even expected - due to rapid changes happening in the marketplace and in the organization. We can longer guarantee that our planning for today will be applicable in nine months," says Mr. Simeunovic.

View the digital release of the magazine, PM Network - Governing Creativity: Marrying Project Management with Innovation. The Agile ERP Project Management article starts on Page 60.

Join us on Tuesday, September 25th, 2012; 9:30 - 10:30 am CST for our free cloud ERP webinar: The Sky's The Limit: Cloud Technology for Mid-Market Companies

Today’s Cloud ERP solutions encompass the full range of ERP functions, including Production / Manufacturing, Supply Chain Management, Finance Management, Business Intelligence, Procurement and Sourcing, HCM (Payroll and HR), Project Accounting, and Sales and Marketing. In particular, Microsoft Dynamics AX, a powerful new generation in ERP solutions, offers Cloud-based functionality that rivals the rich functionality provided by onsite deployments, but at a fraction of the cost.

This solution gives your Mid-Market company:

• Real-time information across your organization
• Easy-to-use inquiry tools
  
• Powerful analysis and reporting capabilities

When Cloud ERP is paired with Finance & Accounting Outsourcing Services in a Business Process as a Service (BPaaS) model, the sky really is the limit! Most Finance & Accounting functions don’t increase a company’s competitive edge, and companies can remove under-performing accounting functions to F&A outsourcing to maximize workflow, reduce staff redundancies and improve profitability, all while enjoying the benefits of a Cloud-based ERP system powered by Microsoft.

Join Finance & Accounting experts and Microsoft Dynamics Experts from Sutherland Global Services and Merit Solutions to learn:

• How you can implement a BPaaS solution in your Mid-Market company now.
• How your organization can benefit from Cloud ERP technology.
  
• How you can be sure your data is secure in the Cloud.
• How we meet the specific business process outsourcing and best in class ERP needs of the mid-market with a single solution with rapid implementation.

And before the event, read Everest Group's latest BPaaS whitepaper to learn more about what this unique solution can do for you!

Reserve your spot today!

Microsoft Dynamics AX is designed to empower your people to be more productive and your systems to last longer, with the ability to scale to accommodate growth while delivering the insight you need to respond quickly in an ever-changing world of business.

Simple to Learn and Use
Simplicity is at the core of Microsoft Dynamics AX. It is easy to learn and use because it works like and with other familiar Microsoft technologies, such as Microsoft Office. And Microsoft Dynamics AX works the way you work, so it’s easier for you and your employees to make better decisions and get more done. Simplicity is built into every aspect of your experience—from initial purchase and deployment to ongoing maintenance and upgrades.

Delivers Agility in the Face of Rapid Change
Today’s business landscape is changing at an ever-increasing pace. To stay ahead, you need a business management solution that is designed to help you meet evolving demands. Microsoft Dynamics AX delivers the agility you need to adapt new business processes and extend functionality quickly, making it easier to enter new markets, add capabilities, or reallocate existing investments. In addition, Merit Solutions offers Microsoft Dynamics AX Cloud ERP to give you flexibility to expand or contract as business conditions change.

Drives Value for Your Business
Microsoft Dynamics AX delivers value for your business in three important ways. First, you can increase your return on investment as you boost productivity and create new ways to control expenses, helping to drive profitability. Second, Microsoft Dynamics AX offers interoperability with the other technologies you already use in your organization to help lower your total cost of ownership. Finally, you can achieve maximum benefit from your technology investment through improved time to value, especially when you don’t want or need an extensive IT infrastructure.

Whether you choose an on-premises or a cloud ERP deployment model, Merit Solutions RapidOn Implementation Methodology can get you up and running quickly with tools to accelerate installation, set up and extend core functionality, and migrate data from your legacy systems. And there’s more. Microsoft Dynamics AX is backed by a commitment from Microsoft that includes a 10-year support life cycle for each major release—combined with an ongoing investment in research and development—so that you can grow your business with confidence, knowing that your business management solution can keep up with your ambition.

Compliance can be defined as observance, conformity, and obedience. In business, compliance generally designates the requirement to adhere to certain rules or laws, meet certain standards, and follow certain practices. Compliance standards can originate from external, as well as internal sources. A compliance requirement may be mandatory or optional and they can encompass virtually all aspects of the business environment – from financial and trade to regulatory and environmental. Customers and collaboration partners can also drive compliance adoption. Compliance becomes an important factor in a company’s ability to compete effectively as customers and collaboration partners increasingly require companies to follow certain practices or meet their specific standards. From tax reporting forms to how you place a label on a box for a customer, compliance requirements help drive the ways in which businesses operate.

Understanding the origin of compliance requirements enables appropriate prioritization and risk management. Compliance requirements that your organization must adhere to may be based on your ownership structure, management practices, location(s), and the market(s) in which you wish to participate, as well as your specific industry, customer, vendor, and bank affiliations.

External Drivers
External compliance requirements – whether they are driven by industry organizations, regulatory agencies, banks, trading partners, vendors, or customers – are top of mind among organizations today. Governments generate many regulations directed at businesses, too, and these regulations often provide the business community with the greatest challenges with regard to compliance. Many government regulations, such as the Sarbanes-Oxley Act, 21 CFR Part 11 and the Food Safety Modernization Act, target specific industries and businesses while some apply to all businesses. Government compliance regulations reach across the entire spectrum of business operation activities – from tax collection and reporting, to verification of manufacturing quality and material tracing capabilities, to corporate governance.

Internal Drivers
Managing internal compliance requirements is becoming even more important for organizations. The need to develop and maintain internal controls and corporate content policies and rules such as deciding what documents to save and what to delete, data and document access rights, email attachment rules and management best practices – to name just a few – is driving compliance adoption across organizations.

A complete understanding of the sources of compliance for your organization can help you plan ahead and adopt and retire compliance requirements as those requirements and your organization evolve. The next focus for compliance management then becomes: “How do I adopt a new, strict structure of compliance requirements and keep current compliance actions intact while enhancing my organization’s profitability, and its abilities to innovate, adapt, and optimize?”

Information Technology plays a key role in helping companies manage an effective compliance program and enforce compliance requirements internally and externally. Technology enables the collection, analysis and control of enterprise-wide data, delivering the crucial information needed for intelligent business decisions. Ideally, this means establishing a viable compliance program and having compliance requirements integrated into business management systems like Microsoft Dynamics AX - enabling companies to transform compliance requirements into business benefits and a competitive advantage!

The harsh reality for every Life Sciences company - companies that manufacture drugs, medical devices, or other products with the potential of causing physical harm to humans - is that they must operate in control and according to numerous compliance regulations, including FDA 21 CFR Part 11. But within this constant, every company makes decisions about how to build their processes (tasks and resources applied to activities to produce an outcome) and what strategies to operate with in relationship to these regulations.

The idea we discuss with Life Sciences companies today is growing with muscle, not fat. Specifically, we help companies understand that the many compliance processes that they currently perform with manual methods are very costly relative to growth.

The biggest cost of manual processes is – yes – people. When you grow, you have increased volumes going through your business processes, and variations in those processes based on different types of customers, orders, products, suppliers, etc. Many times it is not a linear relationship, but exponential in terms of the people you have to add relative to the business growth. Sometimes, it cannot be covered just by adding people.

However, the more important costs of manual processes are time and visibility. Manual processes store data in a disconnected and difficult-to-access manner. If data related to these manual processes is required for decision making, there is often a time delay in getting the data into a consistent, usable format. And because it is costly to gather the data, many companies decide to operate without it, which leads to decisions that are less optimal and often time delayed. Of course, on top of all this is the issue of errors related to gathering and entering the data in to a usable format.

The bottom line is that manual processes add stress, costs, and risk to an organization, and is one of the main drivers for looking at automated compliance approaches.

Automated compliance is what the market rewards. Ultimately, the supply chain that you are in or will be in will quickly learn of the companies that are able to produce efficiently and with high control and compliance. Many companies that we speak with come to us because they have been given a choice to make about this. Buyers are now demanding that suppliers have an automated approach to compliance because the buyer understands what it means to them.

Traditionally, we talk to a lot of companies that think about efficient business processes and compliance processes as operating in an inverse direction. In other words, if you increase your level of regulatory compliance, you will reduce the efficiency of your business processes, and vice versa. We have found, however, that there are huge gains to approaching both within the same automated manner; thereby increasing the efficiency and flexibility of their business processes at the same time.

Companies can get the best of both worlds - that is, more efficient processes with automated compliance controls - by moving to a unified central business system that has enterprise compliance capabilities built-in already. These systems can help Life Sciences companies:

• Eliminate manual efforts and paperwork, reducing errors and saving time and human tasks
• Audit, capture and store information according to 21 CFR Part 11
• Automatically enforce controls according to SOPs
• Cost effectively and rapidly deploy business systems in a validated manner
• Enforce controls, but with the flexibility to adapt and grow with your changing business over time

At Merit Solutions, we have taken this philosophy and built the model of our company around it. This model includes service methods, pre-built intellectual property, and software components that are built within the Microsoft Dynamics ERP software – all to help Life Sciences companies realize the benefits of reduced risk, increased operational efficiency, and the continued building of a foundation on which to grow.