3 Ways FDA Regulated Manufacturers can Leverage Digital Technology to Improve Consumer Safety

Have you ever asked yourself if you have the necessary IT infrastructure that allows your business to identify opportunities for growth? Today, in the highly competitive Life Sciences and Food & Beverage industries, remaining compliant while optimizing your manufacturing process to meet the demand is a tough challenge.

Investing in the right people, processes and technology can enable you to effectively sidestep some of the challenges while keeping you focused on the long-term goal.

So how can FDA regulated organizations use technology to manage the challenges in this complex and ever-changing environment?

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Life Sciences Organizations Succeed Under Pressure with Digital Transformation

Pharmaceutical, biotech, medical device and other life sciences companies are under increasing pressure to succeed in a highly competitive and regulated marketplace. There is no room for error, especially when delivering life-changing products to customers. An integrated business platform for ERP, CRM and BI can optimize operations, support all phases of growth and deliver the very data needed to succeed.

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New White Paper: Using ERP to Prepare for Commercialization

New products in the Life Sciences industry fail to win a significant spot in the market at an alarming rate. And since the costs of bringing a product to market are extremely high – the risk of any missteps can be devastating. Therefore, it makes sense for biotech, pharma, and medical device companies to use every tool at their disposal to ensure they are as prepared as possible. Unfortunately, many companies overlook one of the most versatile tools available to them – their ERP solution.

If you are an early stage and rapidly growing Life Sciences organizations, download this free white paper to learn how Life Sciences ERP systems can help you:

  • Increase corporate value
  • Mitigate risk
  • Ensure compliance
  • Orchestrate your supply chain
  • Setup quality assurance and CAPA processes
  • Manage customer complaints and returns
  • Maintain a validated and qualified environment

Download the white paper now: Using ERP to Prepare for Commercialization.


Is There an App for That?: Pharmaceutical Companies and Mobile Applications

If you’re like the millions of other mobile device users on the planet, you most likely download and utilize applications on your device on a daily basis. Maybe those apps help you stay organized, or they help you communicate faster with friends and family. What is quite probable is that you haven’t downloaded an app produced by a pharmaceutical company. Why is that? Pharmaceutical companies are still in the process of figuring out how to engage consumers through this platform. Mobile devices represent a significant opportunity for pharmaceutical companies – read on to learn more about how they can capitalize on them.

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Mobile Technology Best Practices for Life Science Companies

Mobile technologies have improved the speed at which life science companies innovate. The R&D process, the supply chain, and clinical tests can all run more efficiently and effectively thanks to the competitive advantages mobile technologies offer. That being said, mobile technologies are not without their challenges. Security and compliance are two examples of obstacles life science companies face. However, implementing a set of best practices regarding mobile technologies will enable life science firms to utilize them effectively and safely.

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Life Science Companies and Mobile Security: Overcoming Challenges

Life science companies stand on the cutting edge of technology. Their innovative discoveries save lives and make the world a better place to live. That doesn’t mean that they’re not vulnerable to the same digital threat landscape that affects other firms. This is especially true when it comes to mobile devices. Fortunately, life science companies need not be sitting ducks when comes to mobile threats. Read on to learn about how these businesses can handle mobile security challenges.

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Free Electronic Batch Records Demo Webinar – March 8th

Register now and join Merit Solutions and Ultra Consultants on Tuesday, March 8 at 1:00pm CST for a free Electronic Batch Records demo webinar.

During this webinar we will discuss:

  • Introduction to Electronic Batch Records (and Device History Records)
  • Benefits of Electronic Batch Records systems
  • And an Electronic Batch Record demo of functionality in MAXLife.

We hope you can join us for this free webinar!

Electronic Batch Records
Tuesday, March 8th, 2016
1:00pm – 2:00pm CST
Presented by: Merit Solutions and Ultra Consultants

Register Now


Uncharted Territory: The FDA and Mobile Medical Applications

The Food and Drug Administration was created in 1938. It has protected consumers from unsafe food, cosmetics, medicines, and medical devices. In the 21st century, the agency must now contend with the role of mobile technology in medicine. The FDA is still determining its regulatory scope in this field, but there are a few decisions it has made that impact life science companies.

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MAXLife Video – Microsoft Dynamics AX for Pharmaceutical, Medical Device, and Biotech Organizations

Why should pharmaceutical, medical device, or Biotech organizations considering new enterprise ERP systems include MAXLife for Microsoft Dynamics AX in their shortlist of potential solutions?

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Medical Device Consulting Services and Software Solutions

For medical device manufacturers, success depends on cost-effectively maintaining regulatory compliance, driving rapid technological innovation, efficiently documenting quality data, managing product life cycles, and driving higher value to customers. It takes a lot risk management and continuous improvement to remain competitive in the face of these complex requirements.

Medical Device manufacturing companies operate in one of the most competitive – and regulated – industries today. Like many technology, electronics, and device manufacturing organizations, success in the Medical Device industry depends on a company's ability to produce the highest quality products faster than the competition. Unlike many other industries, however, Medical Device manufacturers must meet some of the most stringent government and customer compliance regulations regarding documentation, controlled processes, and product safety.

This requires more than medical device ERP or Quality Management software.

Sure, Medical Device companies need features like electronic device history records, CAPA, track and trace, recall procedures, learning management, document management, kitting and assembly, warranty and more. But all of these features mean nothing if your people do not accept change and adopt the system; your workstreams are inefficient; the solution is not validated or implemented correctly; or there is no foundation for continuously improving value to customers.

Therefore, it is extremely important that any Medical Device company looking to undertake an enterprise transformation project works with a proven consulting partner with expertise streamlining workstreams, mitigating risk, facilitating organizational adoption, and implementing compliant software solutions.

MAXLife for Life Sciences

Merit Solutions enables Life Sciences organizations to transform their business with MAXLife, a robust and pre-configured Microsoft Dynamics AX solution that is deployed in the cloud using Microsoft Azure. MAXLife consists of pre-built business process models, industry-specific documentation, implementation templates, and integrations with top vendors – creating a preconfigured solution that can be “dropped in” with standard configurations or used as an “accelerator” for global deployments.

Learn more about MAXLife for Life Sciences.

Why Merit Solutions?

Merit Solutions has been working with Life Sciences companies for more than a decade, helping them manage risk, ensure operating performance, maintain compliance, and pursue global growth opportunities. Through our industry-tested combination of front end process consultants, back end technology practitioners, and industry Subject Matter Experts, we have the expertise to enable your successful Life Sciences business transformation.

Our broad range of Life Sciences consulting services and IT solutions help address the challenges related to traditional processes, cultural resistance to change, and less scalable technologies – enabling successful improvement projects while operating in a globally regulated environment.

Life Sciences companies that partner with Merit Solutions typically experience the following results from their investments:

  • Reduced Compliance Costs – Merit Solutions helps Life Sciences companies define a compliance strategy, designing the preventative, data integrity, and significant process controls required to carry out and efficiently operate your enterprise compliance strategy. Along with our partners, we help clients deploy validated systems that have effective change management built in to support the changing needs of your company moving forward.
  • Reduced 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. Automated systems and processes also reduce the risk of human errors, which can result in redundant processes, rework, or even audits. And the eliminate the large costs associated with printing, reviewing, storing and retrieving paper documents.
  • Increased Ability to Rapidly Scale – When you grow, you have increased volumes going through your business work streams, and increased variations in those work streams coming from different types of customers, order, products, suppliers, and partners. Merit will help you remove the disorganization potential of paper-based and manual work streams, eliminating risk and impediments to your rapidly growing company.
  • Faster Innovation and Reduced Cycle Times – Significant increases in the volume and complexity of internal and external business data provide growing challenges when locating, retrieving, sharing, processing, and distributing that information. We help companies enforce the consistent execution of processes while providing an accurate, real-time view of critical data to those who need it.
  • Improved Decision Making – Merit helps clients eliminate the time delay in getting accurate, consistent, and usable information that comes from manual and paper-based processes. By implementing work streams and information flows that connect your activities in the most efficient manner for delivering customer value, we are also enabling real-time access to the most important information the company needs for business decision making.

Merit Solutions helps our life sciences clients drive their business, process, and enabling systems changes required to achieve their strategic vision and goals. This includes everything from future state business process mapping to systems analysis, fit-gap process definition and scoping, sourcing, design and deployment, integration with other systems, on-going support, and systems validation.