8
Jun

Mitigating the Risk of Mobile Device Usage in Clinical Trials

Clinical trials are long, costly, and generally a huge undertaking for companies. Mobile devices can change that – they enable patients to participate remotely, saving money and time. That being said, mobile devices present some risks. Those risks can be mitigated, though. Read on to learn the risks of using mobile devices during clinical trials and how to mitigate them.

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21
Apr

How Life Science Industry Field Service Technicians’ Usage of Mobile Technology Can Save Your Bottom Line

When you think about mobile technologies, what most likely comes to mind is the concept of efficiency and increased productivity. What you might not realize is that mobile solutions can also boost a company’s profits or save money. This holds true of the life sciences industry. When field service technicians use mobile technologies, they can actually improve their firms’ bottom line – read on to learn more.

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28
Dec

Life Sciences Videos

In order to sustain profitable growth, today’s Life Sciences companies must redefine the way value is delivered, reduce costs and eliminate waste, and enhance quality and safety.

Fill out the form below for access to the following Life Sciences Videos:

  • Life Sciences Webinar: Electronic Batch Records
  • Life Sciences Webinar: Business Process Improvements
  • Integrating Dynamics AX into a Hybrid QMS Environment

  • Green Validation: Automating The Validation Process

31
Aug

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.

31
Aug

Biotech Consulting Services and Software Solutions

Success in the Biotech industry depends on time-to-market. Like any other manufacturer, Biotech companies are being pressured more than ever to introduce new products faster than ever before – and with higher quality and lower costs. Unlike many other manufacturers, though, Biotech companies are under an immense amount of pressure to recoup massive R&D costs.

Biotech firms face major challenges with workstream efficiency, maintaining regulatory compliance, and high operating costs. The only ways for Biotech companies to stay competitive is to constantly streamline activities and reduce compliance and operational costs. However, Biotech companies cannot let these goals threaten product quality, consumer safety, or value to customers.

We are finding that many Biotech companies are still using legacy systems and paper-intensive processes. In order to maintain a competitive advantage, executives in the Biotech industry need to be able to fully understand and address how certain business workstreams and activities impact margins and bottom-line profitability. This means they need end-to-end visibility across all areas of the organization, from finance and sales to manufacturing and quality management, to maintain margins and drive higher value – especially cash-intensive workstreams like R&D.

At the same time, Biotech companies need to reduce risks created by compliance with governmental and customer regulations by automatically supporting compliance with complex regulations. This alone can save valuable time and money.

It is extremely important that any Biotech company looking to undertake an enterprise transformation project works with a proven consulting partner with experience 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.

31
Aug

Industry Specific ERP Consulting Services

INDUSTRY SPECIFIC BUSINESS TRANSFORMATION CONSULTING SERVICES

It doesn't matter if you are a process manufacturing organization or a global consumer products enterprise, you need people, workstream, and enabling technologies that support the unique industry-specific requirements in which you operate – without costly and time-consuming customization and development.

But the transition to new workstreams and improved information flows can be a challenge.

Merit Solutions has built teams around each individual industry we serve, combining Subject Matter Experts and technology professionals who have worked in and with our industries for a number of years. These industry teams have proven success working together to help clients mitigate the risks associated with enterprise transformation projects in their market.

Our Industry Specific Consulting Services

28
Aug

Advanced Lot Management

(You are on our Microsoft Dynamics GP Advanced Lot Management Page. If you are interested in Enterprise ERP and Lot Management solutions – check out our Microsoft Dynamics AX Page for more information.)

Expand your ability to operate efficiently while controlling restricted materials within Microsoft Dynamics GP Manufacturing. Increase operating control, track all lot information completely, and automatically maintain compliance with FDA requirements.

Increase Control

  • Impose material use limits through Expiration Date field.

  • Control Lot Status with the addition of four status assignments: Hold, Approved, Quarantined and Rejected.

  • Manage lot transactions by only allowing use of approved materials in manufacturing and distribution.

  • Enforce rules for specific data choices and tolerances for lot characteristics.

Track Lot Information – Completely

  • Track lot information in key stages of inventory processing such as Manufacturing Order Receipt and Inventory Adjustments.

  • Works with Dynamics GP Inventory—Sales Order, Purchasing Order and Manufacturing Order Processing.

Maintain Compliance – Automatically

  • Advanced Lot Management is configurable to support your company-specific process and compliance rules.

  • Used with the Risk Management Suite, Advanced Lot Management operates in accordance with the requirements of FDA 21 CFR Part 11.

LEARN MORE

Contact Merit Solutions for more information on Advanced Lot Management.