Merit Matters Blog

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.

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.

Merit Solutions is featured today in the Microsoft Dynamics Partner Community Blog for "Kati Unplugged", a blog series for Microsoft Dynamics Partners by Kati Hvidtfeldt, US Microsoft Dynamics ERP Cloud Lead. In the article, I explain how Merit Solutions was able to help a leading medical services industry player - Innovare Health Advocates - implement a Microsoft Dynamics AX 2012 Life Sciences Cloud ERP Solution that fits their needs and budget like a glove.

You can read the full article here: Kati Unplugged: How Merit Solutions Implemented its Cloud-Based Vertical Solution to Help Position a Client for Growth

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.

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!

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.

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.”

After spending more than 10 years working with the smallest medical device manufacturers to larger pharmaceutical organizations, we understand the unique needs of the Life Sciences Industry. For that reason, Merit Solutions developed MAXLife ERP - to help our clients overcome the business challenges of today while building and remaining flexible for what the future brings.

Quality Management

Take advantage of a fully integrated Quality Management system that enables you to improve product quality and safety, reduce organizational risk, and increase customer satisfaction.

• Cradle to Grave Lot Traceability
• Corrective Action Preventive Action (CAPA)
• Cost of Quality Management

Compliance Management

Enjoy extended Compliance Management features that support FDA requirements (including 21 CFR Part 11), Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs).

• Controlled Documents Management
• Audit Trails / Electronic Signatures
• ePedigree Tracking and Management

With MAXLife software for Microsoft Dynamics AX, you can track product quality, proactively see and respond to manufacturing variability, meet GxP, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

Learn more about Merit Solutions Life Sciences ERP Software, named one of the Top 15 Add-ons for Microsoft Dynamics AX by the site DynamicsWorld.