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Compliance: Robust Reporting is Key

Government regulations are becoming more prevalent and we can only expect this trend to continue. Just because they don’t touch your business today doesn’t mean they won’t in the near future. Compliance isn’t just for the finance folks anymore. Which is why it’s important to consider compliance issues while selecting an ERP software solution.

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FDA and Industry- Bridging the Risk Management Gap

Even with the best design and steadfast controls, sometimes things go wrong. Deciding on a risk profile and executing the appropriate action may be interpretive. Manufacturers have the hurdle of coming to an agreement with the FDA. Inevitably, they don’t always agree. An attempt was made last year to bridge the divide by creating a working group consisting of manufacturers, the FDA and representatives of a nonprofit group representing healthcare technology professionals. This group seeks to create a consistent means to evaluate risk between regulators and manufacturers. They will provide feedback to the FDA on specific areas where better guidance would be beneficial.

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Enterprise Mobility: A Natural Fit for Life Sciences

Enterprise mobility has a transformative role to play in every industry. The field of life sciences is no exception. Implementing appropriate mobile technologies enables life science firms as well as healthcare practitioners to deliver the best patient outcomes to consumers. There are so many kinds of mobile technologies, though – which ones will be of greatest use?

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Medical Device Security-Beyond a Data Breach

In today’s technology obsessed world, even the delivery of healthcare is dependent on software driven devices. Some are standalone, others are networked together. With the ever growing web of connectivity and the movement towards personal medical care, security issues predictably arise. Hacking has become so common place, we are no longer surprised when it happens. Losing your credit card information is bad enough but what if a wearable device was compromised by an anonymous cyber criminal? Remember, the motivation for someone to control another individual’s pacemaker or insulin pump is irrelevant, the point is that if something can be hacked, someone will find away to do it. Hackers may use these devices as another means to troll for personal information.

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Life Sciences Executive Webinar Series - "Mastering Compliance and Innovation"

Merit Solutions and OnShore Technology Group are excited to launch a new monthly Life Sciences Executive Webinar Series titled "Mastering Compliance and Innovation”. This series will identify ways Life Sciences organizations can excel beyond the basics and leverage innovative technologies to achieve continuous improvement and global success.

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Data Integrity - Being the Trusted Source

Issues with data integrity have always existed. With recent egregious cases, the FDA has been taking greater measures to uncover these attempts to misrepresent key data. There have been stories of inspectors looking through the contents of garbage cans to find discarded documentation. Additionally, they are receiving specific training to better identify faulty data.

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Client Spotlight: MannKind Corporation

Merit Solutions' client MannKind Corporation (Nasdaq: MNKD) is a biopharmaceutical company focused on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes.

We recently sat down with Van Kwok, Associate Director of MannKind, and asked him to discuss his partnership with Merit Solutions.

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Taking Another Look At Automated vs. Manual Compliance

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?

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.

MAXLife Cloud Featured in Microsoft Dynamics Partner Community Blog

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