Merit Matters Blog - MAXLife

AKA Enterprise Solutions Announced as MAXLife Reseller

nospam@example.com (Josh Richards) — Thu, 23 May 2013 13:56:00 -0400

AKA Enterprise Solutions, a leading Microsoft Gold Certified Partner dedicated to the implementation, training and support of Microsoft Dynamics AX for Life Sciences companies, announced today that they have signed a Reseller Agreement with Merit Solutions, Inc. to resell their MAXLife ERP software. The signing of the Reseller Agreement will enable AKA Enterprise Solutions 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.

“For more than two decades, AKA Enterprise Solutions has been committed to providing clients with the precise technology and consulting solutions to meet their unique business needs,” said Ronald Haantjes, Vice President of Client Relations, AKA Enterprise Solutions. "The industry-specific improvements offered by MAXLife is going to transform the way our clients maintain product quality and regulatory compliance. Customers will be able to overcome stringent industry challenges - like 21 CFR Part 11 Compliance, CAPA, Electronic Batch Records, System Validation, and more - in order to sustain profitability and growth. This announcement strengthens the value we can provide to the Life Sciences industry and will further enable AKA Enterprise Solutions 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 utilizing 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
System Validation
Enhanced Approval Controls and Quality Orders
and more!

"AKA Enterprise Solutions has long been recognized as one of the leading Microsoft Dynamics AX partners worldwide. They are a very 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 AKA team brings years of experience working with Microsoft Dynamics AX in a Life Sciences / FDA regulated environment, 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 AKA Enterprise Solutions as we continue to grow and expand."

About AKA Enterprise Solutions

For more than two decades, AKA has been one of the country’s leading Microsoft Gold Certified partners providing clients with superior delivery, implementation, service and support of Microsoft Dynamics offerings such as Dynamics AX, GP and CRM and Business Intelligence (BI). AKA understands, develops and, most importantly, integrates leading solutions for life sciences clients. AKA has been awarded six out of the past ten years as one of the top three Microsoft ERP partners worldwide. More information about AKA Enterprise Solutions can be found at http://www.akaes.com.

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.

Top 7 Benefits of Electronic Batch Records (EBRs)

nospam@example.com (Josh Richards) — Mon, 13 May 2013 10:29:50 -0400

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.

Top 8 Pitfalls and Challenges of Life Sciences CAPA Systems and Processes

nospam@example.com (Josh Richards) — Wed, 08 May 2013 14:59:42 -0400

Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483 observations and warning letters cite Corrective Action / Preventive Action (CAPA) incident management deficiencies.

Every Life Sciences company needs to have an effective CAPA system in place to minimize risk and ensure compliance with regulations, but maintaining an effective CAPA process can be challenging. Challenges can occur at every step of the CAPA process and it requires vigilance to ensure that they don't derail the process and expose the company to unnecessary or excessive risk.

Here are the top eight challenges of CAPA systems and processes:

CAPA Silos: The biggest challenge Life Sciences companies find themselves caught with is a silo’d CAPA system (or multiple CAPA systems) in which the data in the CAPA system(s) cannot be effectively shared across the company or cross-referenced with other data. This makes it hard for companies to link related problems – and even harder to generate metrics and perform trend analysis on elements like products, problem types, root causes, costs, and more. These companies need to break down their CAPA silos to achieve a single, managed, integrated and complete view of the process - and enable a common way for them to do trending and put preventive action in place across the company.
Complex Processes: The first step of effective CAPA systems is to create and document the process. However, companies often make the mistake of trying to build every potential exception condition or possible incident into the CAPA system – which makes it too complex for people to understand and follow. Complex systems lead to slow resolution and aging CAPAs because people are unsure of the next steps. Instead, CAPA systems and processes need to be simple, yet comprehensive – and they need to include a process for escalations and exceptions that provides guidelines but doesn't necessarily dictate specific steps that may not be appropriate in every case.
Lack of Documentation at Every Step of the CAPA Process: When people are in a hurry to resolve an issue before it escalates, they naturally tend to focus on taking the action rather than documenting the reasoning behind the action. Part of an effective CAPA process should be full documentation at every step; your people don't need to write a novel before every action, but they do need to record what they are doing and why. Be careful not to let documentation lag the CAPA process because you can lose valuable information; however, employees need to answer the “who, what, when, where, how and why” questions for every step.
Confusion between a Corrective Action and a Preventive Action: A Corrective Action generates a solution to issues that have already occurred. A Preventive Action looks for solutions to problems that might occur. Don't fall into the trap of thinking that every problem and every process change needs to have a CAPA to justify it. That will bog down your system and critical actions may not get resolved as quickly because of it. Instead, ensure that people understand the distinctions between corrective actions and preventive actions, and that they reserve them for actual or potential incidents.
Imprecise Language: If people can't state the problem succinctly, the team will be unlikely to resolve the issue or even to measure results of their actions. People often try to jump ahead to possible solutions when defining the CAPA or they get emotional in their description. Neither choice is conducive to rapid resolution, so don't tolerate sloppy problem definitions. Make sure team members are trained in writing simple, concise problem statements that highlight the difference between the current state and the future state. When people know the starting and ending points, plotting the route and measuring progress are much simpler. It also makes it simpler to determine relative priorities and risk associated with each incident of non-conformance.
Jumping to Solutions: This is often a direct result of imprecise problem statements. When people jump to conclusions about the solution to the problem before fully defining and investigating the issue, they may make "corrections” that don't correct anything. Instead, companies need to insist that every problem statement answers the "who, what, when, where, how and why," as well as the frequency and severity of the effects of the problem. Don't let panic about compliance cause people to rush through the steps, because you may end up addressing the symptoms rather than the causes of the problem.
Insufficient Process Training: After CAPA processes have been sufficiently defined, companies need to make sure to train employees in the proper steps and procedures. Many companies train people to follow the rote steps, but they don't provide training in precisely defining the problem or how to determine the severity of an issue. As a result, the CAPA system bogs down with aging or unnecessary corrective actions and preventive actions that remain open due to either insufficient resources or sheer bafflement about the actual issue. CAPA systems and processes require in-depth employee training, and frequent re-training, in order to remain effective and compliant.
Inconsistency in Applying the Process: Many companies today have multiple sites, often in multiple countries or regions. This requires extra diligence to ensure that all sites react the same way and apply procedures the same way. One of the worst situations you can have is having each site following different processes or treating equivalent incidents differently. Companies can prevent this problem with extra training (as mentioned above), and by implementing a centralized CAPA system that connects departments and locations. Don't believe any statements that "we're different" unless you investigate and agree that one site should be an exception. If there is a reason for a different process at a facility, document it and make it part of the corporate process.

It requires vigilance to ensure regulatory compliance, but effective CAPA systems and processes should be an important part of your compliance arsenal. When used correctly, your CAPA systems will help you resolve non-conformances quickly and minimize risk.

MAXLife's Corrective Action Preventive Action (CAPA) Incident Management ERP Software capabilities enable you to increase control and assuredness for how your organization operates. With MAXLife, you can generate a Corrective Action or Preventive Action request that routes through review, root cause, corrective action taken, and verification stages. This CAPA tracking software generates multiple reports automatically, providing an effective mechanism for tracking the source and costs of problems. It also enables companies to improve brand loyalty and customer satisfaction by continuously improving quality and responding quickly to potential incidents.

MAXLife at the Microsoft Dynamics AX Industry Summit

nospam@example.com (Josh Richards) — Mon, 04 Feb 2013 15:59:00 -0500

Merit Solutions is proud to be sponsoring and presenting at the Microsoft Dynamics AX Industry Summit next week in Phoenix, Arizona. During the event, Merit Solutions will be on-stage presenting two topics:

Selling to Mid-Market Pharmaceuticals - Wednesday, 2:30 - 3:30pm in the Mesquite Room

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.

ISV Showcase - MAXLife for Pharmaceuticals - Thursday, 9-10am in the Mesquite Room

During this session, we will present MAXLife - our Life Sciences software solution based on Microsoft Dynamics AX and Microsoft SharePoint. MAXLife is a complete pharmaceutical ERP, quality management, and controlled document management solution. With MAXLife, you 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.

Please let us know if you are attending the Summit and would like to schedule a meeting with Merit Solutions CEO, Bill Burke, or Director, Mike AuBuchon.

If you cannot attend but are interested in a copy of either presentation, please reply below or send an email to info@meritsolutions.com! Otherwise, we hope to see you next week!

Taking Another Look At Automated vs. Manual Compliance

nospam@example.com (Bill Burke) — Thu, 26 Jul 2012 17:07:09 -0400

Time to take another look at automating FDA compliance?

“Gosh”, you say, “need we or any pharmaceutical manufacturer look any further than the mountains of forms we fill out hourly in order to get an order out the door?”

YES, it’s time to take another look at compliance because the FDA’s swelling ranks give you new reason to do so. This means even more FDA inspectors fully schooled in regulations of 21 CFR Part 11 that pharmaceutical firms must live or die by. In our post 9/11 reality, you would be in your rights to suspect that these ranks will swell even more in years to come because, like it or not, public security demands that this be so. However, the BIGGER reason why you should revisit this now is that there are a growing number of systems out there that will allow FDA compliance for fast-growing firms, and finding right-sized solutions can be THE KEY to profitability.

FDA regulations do not require you to automate your business systems, and you will never find an FDA regulator who will tell you to do so. But if you make a frank comparison of man vs. machine, you can see why any FDA regulator worth their pay breathes a sigh of relief when they monitor pharmaceutical manufacturers that use widely recognized and standardized integrated business systems known to be adapted for FDA 21 CFR Part 11 compliance. Pharmaceutical manufacturers that use such integrated business systems can be expected to be a long way down the road of compliance. An otherwise comparable pharmaceutical manufacturer that uses entirely manual processes and handwritten records is quite a bit more suspect.

Unlike you or me, an automated system will do a programmed task exactly the same way every time. Humans have moods; machines do not. Humans are subject to sleep deprivation, attention lapses, bad attitudes and bad days. Good ‘ol automated systems just plug away the same way each and every time. While a very 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 and never prompt an operator to skip required steps for quality control and authorized signatures. No system that involves human action is bullet-proof, but automated systems can reduce risks of sloppy practices considerably. On the other hand, machines might fail miserably at finding creative solutions to new situations, and to the extent that compliance hinges on skills to handle exceptional situations, human hands and minds come to play a part.

It’s the FDA’s job to keep an eye on how much of a risk your business poses to the public. In turn, it’s your job (along with all members of your company’s executive team) to determine the limits of regulatory risk your company can handle. Regulatory risk is the risk of being found out of compliance. The financial risk of non-compliance includes costs of additional inspections, lost production time, unsellable product, recalls, plant shut downs, company fines, jail time for executives, and/or public relations fiascoes that put you out of business.

On the other side of the equation are the costs for compliance. In a totally manual system those costs usually involve added head count, along with all the salary and benefits such staffing requires. Automated systems not only have upfront costs for software (and sometimes hardware) but also for training, and validation of the systems. Sometimes automated systems themselves bring on added costs for IT expertise, and ongoing costs to ensure that the systems are updated and in synch with evolving Standard Operating Procedures.

Because information systems can lower people costs but generate their own costs, there has to be a balance to create the right level of automation at an appropriate cost. The type of products that your company manufactures and the processes that it takes to do so have a right-sized mix of manual and automated systems that will rely on computers for repetitive operations and humans for handling exceptions. Moreover, the size of your company is one of the best indicators of the degree of automated compliance that will pay off for your firm.

The largest pharmaceutical manufacturers that have numerous plants spanning several continents and many product lines, are the only types of companies likely to benefit from full (or nearly 100%) automation for compliance. Such large companies need centralized control and standard procedures to leverage their size advantage and lower the overall compliance costs (and risk!) on a per plant basis.

The smallest start-up pharmaceutical manufacturers that still have one foot in the research lab from which they spawned, are right to have sticker shock when they consider the integrated business systems the behemoth-sized pharmaceutical firms employ. But where many of these companies get into trouble is in not re-visiting the equation as their company grows.

First of all, integrated business systems vary widely in cost, with the ones geared for the largest companies in need of near total automation cost as much as 5 times what a comparable system geared for a mid-sized company would need. Secondly, the costs of compliance and costs of non-compliance are only a fraction of value created by integrated business systems. Within or without the pharmaceutical industry integrated business systems pay for themselves by helping cut the costs of production and doing business, e.g. by speeding product cycle time, cutting inventory costs, and more. Third, the disorganization potential of paper-based business systems is far more dangerous to a rapidly growing company. If you feel that you are already awash in paper, you may well be one of those companies that is so consumed in managing paper trails that you cease to see how crippled your operation is. And finally, a host of 3rd parties that can be critical to a mid-sized pharmaceutical firm’s continued success - from FDA inspectors, to Venture Capital sources, to banking institutions, etc.-will look positively on pharmaceutical firms with business systems on par with their scientific expertise.

Can Automated Compliance AND Efficient Business Process Coexist?

nospam@example.com (Josh Richards) — Wed, 25 Jul 2012 15:37:33 -0400

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.

Lots More Than Lot Tracking! - What FDA 21 CFR Part 11 Is and Is NOT

nospam@example.com (Bill Burke) — Wed, 11 Jul 2012 14:07:51 -0400

Since we're up in Toronto this week attending Microsoft's Worldwide Partner Conference, we thought we'd repost an article from our archives. This article was originally written by Merit Solutions' President Bill Burke, and was published by Pharmaceutical Processing in March of 2004. It's an oldie (but goodie) - Enjoy!

"Think that because you have strong controls for lot tracking and traceability you are fully compliant with FDA CFR 21 Part 11?

Think again! The truth is, lot tracking is more tangential to what FDA CFR Part 11 is all about, and far from being the pith of the matter. Yes, you must address lot tracking to be FDA-compliant, because lot tracking with integrity is an essential part of FDA-mandated GMPs (Good Manufacturing Practices). But lot tracking and other ingredients of product accountability are NOT what FDA CFR Part 11 is about. Rather, Part 11 addresses the closely related but separate matter of your data accountability.

"Data accountability--- huh????" you ask. "What's that?" Okay, let's consider the nightmare scenario that someone over at the FDA is probably already thinking about for another industry, and how 21 CFR Part 11 would look for them. Imagine a day when incidences of so-called mad cow disease become widely prevalent such that tight controls along the lines of FDA CFR 21 Part 11 are seen as necessary.

If that horrid day arrives and you, the farmer, unwittingly think that FDA CFR 21 Part 11 is just about lot tracking, you would dutifully put tracking numbers on every cow (just as they do in Canada) and mistakenly feel comfortable that your operation is fully compliant with FDA CFR 21 Part 11. This would be a very important step-i.e. numbering all cows in the herd. However, data accountability would mean that you not only can trace herd numbers, but also you have a complete historic record of where each animal ate, what it ate, where this food came from, when the animal ate it, who fed the cow, what the cow weighed before and after it was fed, where it slept, any exposures to cows in other lots, etc. You, the farmer, would not only need to keep this data, but you would probably need the equivalent of a dual password on a computer screen to get access to cows in a particular pen, and certainly would need such password protection before you were able to gain access to move cows out of a pen. Each and every time you or any and every farmhand did something with the cow, you would need to record it or track it, such that there is a complete data record of every cow's lifetime for every cow in the herd.

If you think that sounds potentially complicated, you couldn't be more right. And that is probably one reason why the FDA has NOT run to demand FDA CFR 21 Part 11 compliance to minimize the already miniscule incidence of Bovine Spongiform Encephalopathy. However, the FDA DOES demand that this type of life cycle data be recorded in great detail for pharmaceuticals. In fact, if you haven't invested in electronic systems that are known to be fully compliant with FDA CFR 21 Part 11, you might need to spend as much as $500,000 to write custom tracking automation software that brings you in reach of compliance on top of whatever pretty penny you have already spent to put in non-FDA compliant systems. Luckily, there are workable systems that are fully-FDA CFR 21 Part 11 compliant that do not come with that kind of price tag, especially if you are a mid-sized firm.

What FDA CFR 21 Part 11 is about, is the reliability and auditability of your electronic systems en toto. Even before the post-9/11 consciousness of how terrorists might try to wreak havoc, the FDA's regulations had the wherewithal to demand that data integrity be airtight. Let's take a look at some of the specific requirements and what this means for you and every pharmaceutical manufacturer.

Section 11.10 c, for instance, mandates "Protection of records to enable their accurate and ready retrieval throughout the records retention period." That means that your business systems need to capture all transactions, including updates and changes, and archive them in an accessible database that can be viewed, printed, exported and/or downloaded throughout the records retention period. "Ready retrieval" doesn't mean you can let your IT staff come up with some sort of procedure if and when the FDA requests data-it means you need to have this information accessible in keystrokes right away if and when it is required AND that this data is not changeable by happenstance.

Section 11.30 c, for example, stipulates that "loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls." This means that your manufacturing systems need to automatically disable a user account in the event of password loss or theft to protect data security.

Thus, in these as with all other details, FDA CFR 21 Part 11 is about data accountability. You either have it or you don't.

Sad to say, far too many pharmaceutical manufacturers seem to not only not be FDA CFR 21 Part 11 compliant, but to fail to even grasp what having it would require. Consider the firm that invests in ERP systems widely used in other industries, without considering if FDA compliance has been either built-in to the system or available as add-ons. And consider the potential that those with malevolent intent have to ravage the integrity of data essential to the profitable operations of your business. However carefully you consider this problem, know that the FDA already has, and the sum of their concerns is called FDA CFR 21 Part 11."

Learn more about MAXLife, Merit Solutions' pharmaceutical software for 21 CFR Part 11 compliance.

Enhance Productivity and Boost Collaboration

nospam@example.com (Josh Richards) — Fri, 22 Jun 2012 16:32:04 -0400

In today's cost-competitive world, Life Sciences companies require ways to sustain enhanced employee productivity. However, in order to truly empower employee productivity, these companies need software solutions that can give their people easy access to accurate, real-time information.

MAXLife ERP enables true productivity for Life Sciences companies by providing a software solution that employees will actually use. With MAXLife, employees are provided a familiar interface that quickly connects internal people—and even external business partners—to the right information and tools to work faster and smarter.

With a tightly integrated Life Sciences Software solution, Pharmaceutical, Medical Device, and Biotechnology companies can successfully:

Eliminate time-consuming and error-prone data re-entry resulting from multiple, disparate systems.
Help task workers communicate and collaborate across locations, departments, time zones and organizations.
Enable employees to work with tools they already know and understand, such as Microsoft Office Outlook and Excel.
Provide self-service functionality, enabling employees to perform a range of tasks that they would otherwise defer to IT.
Provide role-based access to information, consolidating common tasks to a single screen.

MAXLife supports your people in their day-to-day tasks, helping them improve communication and collaboration and discover better ways to work with one another. By tying people to the right process in their organization, Life Sciences companies can now achieve new levels of personal productivity and collaboration.

Life Sciences Materials Control Management Software

nospam@example.com (Josh Richards) — Thu, 17 May 2012 15:07:25 -0400

As a Life Sciences Manufacturing or Distribution organization, it is your responsibility to track and trace all products from the time they are received or manufactured through delivery to your customer. At any given moment, you can experience a material or quality non-conformance incident that requires you to investigate further.

The bottom line: you don't want to be one of the companies caught without an adequate Materials Control software system! You need to have the prevenative tools and controls in place to quickly and effictively perform investigations and measure the potential impact of any quality incidents. Unfortunately, many companies today do not have adequate systems in place and are putting their company at risk.

Benefits of the MAXLife Materials Control Workbench:

Improve efficiency by removing manual or paper-based processes.
Adhere to regulatory compliance requirements.
Forward and backward traceability for all material lot / serial numbers.
Streamline and automate product traceability processes.
Improve quality control and customer satisfaction.
Quickly notify Customers, Vendors, or employees of potential quality incidents.

The MAXLife Materials Control Workbench enables Life Sciences companies to access and view any material lot and / or serial number, the status of that material, and all of the locations of that material - at the click of a button! And, if you need to notify vendors, customers or internal team members of a potentially adverse situation or investigation, you can quickly send out an email within the MAXLife Materials Control Workbench notification center.

With the MAXLife Materials Control Management Workbench, Life Sciences companies can minimize risk, maximize product safety, and deliver greater value to their customers.

Learn more about MAXLife Life Sciences software.

NEW MAXLife Life Sciences Software Website!

nospam@example.com (Josh Richards) — Wed, 16 May 2012 17:10:19 -0400

We are excited to announce the launch of our new MAXLife ERP Software website! The new site provides a fresh new look and feel meant to enhance the overall user experience. It has been updated with new product information, demos, white papers, and deeper, more content-rich landing pages.

MAXLife ERP addresses the industry-specific challenges 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.

Learn more about MAXLife ERP:

Electronic Batch Records: Reduce manual processing and operating costs by tracking Batch Records electronically, having them go through a life cycle of approvals, security, and workflows along the way.
Life Sciences Quality Portal: Manage all of their quality and compliance unstructured documents - such as SOPs, Quality Programs, Training materials, etc... - in a 21 CFR Part 820 compliant environment.
Materials Control Workbench: Access and view any material lot and / or serial number, the status of that material, and all of the locations of that material - at the click of a button!
CAPA Incident Management: Streamline and automate Corrective Action Preventive Action (CAPA) incident and non-conformance management processes to correct and prevent issues, measure outcomes, and continuously monitor the system.
Cost of Quality Management: Track and analyze all costs related to performing quality processes to improve product quality and reduce the cost of quality.

MAXLife Life Sciences Software is based on Microsoft's most advanced and feature-rich ERP system, Microsoft Dynamics AX. Gartner, Inc. has named Microsoft Dynamics AX a “Leader” in its ERP Magic Quadrant, and Nucleus Research has found that Microsoft Dynamics AX customers achieve returns in areas of increased visibility, increased productivity, and reduced costs. And with MAXLife Cloud ERP, you can give your employees real-time visibility and anytime, anywhere access to the critical business data they need to be successful - without compromising functionality or security.

MAXLife software increases your visibility into product performance, resulting in better decisions and increased revenues and profits. It 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, you 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.

Contact Merit Solutions to learn more about MAXLife Life Sciences Software!

Life Sciences Companies: Secure Funding and Satisfy Investors

nospam@example.com (Josh Richards) — Fri, 11 May 2012 16:38:12 -0400

Many Life Sciences companies we talk to today need to define solid business strategies and goals in order to satisfy investors and secure future funding.

As these companies secure funding and look toward long-term planning, they’ll need access to data to provide business insights and help guide strategy. Therefore, they require an enterprise resource planning solution that goes beyond the basics of planning, budgeting, bookkeeping, and managing cash flow. These organizations need the ability to explore their own data to extract insights for strategic planning and to provide reliable financial forecasts. They require a solution that can extract added value from financial data to help improve decision making and better guide the business.

MAXLife for Microsoft Dynamics AX helps Life Sciences companies meet the needs for early stage funding, while enabling them to position themselves for later-round funding by bringing together people, processes, and technologies to help drive business success:

Take advantage of new market opportunities or fend off new competitors to gain market share.
Plan current and future capacity relative to planned growth.
Quickly analyze all aspects of the business to enable better business decisions in high-risk situations.

With MAXLife for Microsoft Dynamics AX, Life Sciences companies have access to accurate, real-time information about product costs, sales trends, and profit margins. This enables more informed strategic decisions about where to spend money, how to grow revenue, and how to strengthen margins.

And with MAXLife Cloud ERP, you can give your employees real-time visibility and anytime, anywhere access to the critical business data they need to be successful - without compromising functionality or security.

Missouri Life Sciences Company Chooses MAXLife Cloud ERP

nospam@example.com (Josh Richards) — Wed, 09 May 2012 16:13:12 -0400

Merit Solutions is proud to announce that a Life Sciences company based in St. Louis, Missouri, has selected Microsoft Dynamics AX in the Cloud with Merit Solutions’ MAXLife Cloud software. Our client will use MAXLife Cloud to support rapid growth plans while maintaining an integrated, end-to-end ERP solution built for the Life Sciences industry.

Our client’s primary focus is to improve and preserve the long term health of individuals one patient at a time. To be successful in this regard, our client needed to utilize up to date information technology to better serve its customers. Prior to selecting MAXLife Cloud, our client was managing their business with spreadsheets and QuickBooks. Company data was located in fragmented silos of systems and machines, causing redundant manual processes and a duplication of effort. As the company developed an aggressive business model that included expansion plans, they needed systems that would improve visibility, streamline processes, and support exponential growth. For these reasons, our client began looking for a new ERP solution.

They ended up choosing Merit Solutions’ MAXLife Cloud because it is simple to use and deploy, is a comprehensive ERP solution that connects all departments with real-time information, and gives them the flexibility to grow, expand, and adapt as needed. MAXLife Cloud was the most cost-effective solution for the company because it works like and with familiar Microsoft technology they use every day. Connectivity and integration with Microsoft SharePoint and other products will enable them to maximize IT investments, minimize training, and increase user adoption. With MAXLife Cloud, our client will utilize integrated document management capabilities, enabling them to control access to business information, provide full versioning, and FDA compliance support. And by deploying MAXLife in the cloud with Merit’s RapidOn Implementation methodology, they can take advantage of lower costs, a more rapid deployment, regular updates, and secure data.

“We are very excited that our client has selected MAXLife Cloud with Dynamics AX to help drive their business growth,” said Mike AuBuchon, Director, Merit Solutions, Inc. “Our team is looking forward to helping them realize the benefits of an integrated Cloud ERP system that will improve efficiency and productivity, enable profitable growth, and support their unique document management needs. We’re confident MAXLife Cloud will be a great fit for them, and other Life Sciences companies with similar business requirements.”

Pharmaceutical Manufacturer Chooses MAXLife for Microsoft Dynamics AX

nospam@example.com (administrator) — Wed, 25 Apr 2012 09:39:49 -0400

Merit Solutions, a leading provider of Life Sciences ERP software solutions, is proud to announce today that Ivancic i sinovi, a partner of Sopharma, has selected Merit Solutions’ MAXLife for Microsoft Dynamics AX to reduce costs and improve quality control. Ivancic i sinovi chose MAXLife from Merit Solutions because of our proven industry experience - and because MAXLife is a Certified for Microsoft Dynamics AX (CfMD) tested solution.

Ivancic i sinovi was founded in 1991 and manufactures and markets pharmaceutical medicines and dietary products - both in capsules and powder forms. The desire to provide consumers with high quality products, created by the latest in medical technologies, in packaging of contemporary design, yet available to everyone, inspired the idea to begin manufacturing.

Prior to selecting Merit Solutions’ MAXLife with Microsoft Dynamics AX, Ivancic i sinovi used a homegrown system that made it difficult to manage business processes across the organization. The system was not integrated with real-time information, which meant executives and managers were often making decisions based on outdated and incorrect data. Ivancic i sinovi also had industry-specific requirements that would not be met with an out-of-the-box solution. With their homegrown system, they could not track or understand the costs associated with quality control processes, which were time-consuming and people-intensive, and resulted in lost productivity, efficiency, and higher costs. And, with expansion and growth plans, the system could not support the expansion of a production plant.

For these reasons, Ivancic i sinovi began looking for a pharmaceutical quality management solution. In the end, Ivancic i sinovi chose Merit Solutions’ MAXLife with Microsoft Dynamics AX because it is simple to use and deploy, is a comprehensive ERP solution that connects all departments with real-time information, and gives them the flexibility to grow, expand, and adapt as needed.

With MAXLife, Ivancic i sinovi will utilize key quality control and compliance management features specific to pharmaceutical manufacturing. Quality incident and non-conformance management processes will be streamlined and automated with MAXLife’s Corrective Action Preventive Action (CAPA) capabilities, enabling Ivancic i sinovi to correct and prevent issues, measure outcomes, and continuously monitor the system. Ivancic i sinovi will also be able to track and analyze all of their costs related to performing quality processes with Cost of Quality Management, enabling them to reduce the cost of quality while maintaining product safety.

“We’re extremely happy that Ivancic i sinovi has chosen MAXLife from Merit Solutions to reduce costs, improve quality, and support their business growth,” commented Petar Miljkovic, Director - Europe, Merit Solutions. “With MAXLife, the company can continue providing high quality, innovative pharmaceutical products while reducing costs, improving efficiency and productivity, and providing safe products to their customers.”

About Merit Solutions:

Merit Solutions is a multinational organization that provides IT services and software solutions to help companies improve their business success. Our industry-specific solutions, MAXFood and MAXLife, along with our core Microsoft Dynamics ERP and SharePoint offerings, enable organizations to increase efficiency, reduce costs, and improve service - while maintaining profitable growth!

A Microsoft Gold Certified Partner, Merit Solutions is AMR Research Industry Certified in Process Manufacturing for Microsoft Dynamics AX. We have recently been recognized as one of Accounting Today's VAR 100, and had two products named in the Top 15 Add-ons for Microsoft Dynamics ERP. Merit Solutions is a Microsoft Excellence Partner for working successfully and collaboratively with customers and partners across the world.