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.
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:
Download the white paper now: Using ERP to Prepare for Commercialization.
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.
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.
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.
During this webinar we will discuss:
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
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.
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.
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.
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:
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.
(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.
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.
Contact Merit Solutions for more information on Advanced Lot Management.