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Product Communications Using Social Media - Like this…or Not

Social media has grown from its simple beginnings of sharing personal information, pictures, opinions and current activities. Companies now utilize its power to reach customers regarding products and specials and news agencies send out headlines and teasers. The reach and purpose has grown beyond updating an individual’s status to a tool to communicate with potential customers. You can even like the FDA on Facebook. (For some Life Sciences manufacturers, there is a tinge of an oxymoron there.)

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FDA Audit GPS

The Coordinates:

We would all like the questions to a test ahead of time.

But unfortunately, an FDA audit doesn’t work that way. The FDA inspects many facilities every year across the spectrum of product types. So how do they determine how to get through this mountainous list? Manufactures have to register with the FDA and provide a list of products that they make. Different products have different risks-an implantable is different from a toothbrush. Those products with a higher risk have a greater need for an inspection.

They will look at reportable records and recalls not only for severity but frequency as well. Consumers or healthcare providers complain directly to the agency as well. This will draw attention to you. The newness of a device will also contribute to putting you on the list.

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AXUG Summit Session: Microsoft Dynamics AX Rescues

Join us at AXUG Summit 2014 for our session, Risks, Warning Signs, and Best Practices for Stabilizing Your Microsoft Dynamics AX Project.

Enterprise Microsoft Dynamics AX projects face a number of risks and challenges due to the transformational impact they have on companies. And recently we’ve seen an increase in the number of companies who receive limited value from their investment into Microsoft Dynamics AX because the system was not implemented correctly - or hasn't even been implemented at all! Join us for this session as we discuss the major risks associated with Microsoft Dynamics AX enterprise projects, how to identify the warning signs that your project is under stress, and ways you can stabilize, turnaround, and optimize your enterprise platform

This session takes place Thursday, October 16th from 3:15 - 4:15pm in Room 105.

AXUG Summit Session: Business Transformation for Life

Merit Solutions is proud to have the opportunity to present the following session at AXUG Summit: Business Transformation for Life: Thinking about Implementing Dynamics AX (and related systems) with Long-term Support in Mind

This session is takes place on Wednesday, October 15 from 1:00 - 2:00 pm in Room 102. The session is built around why it is important to consider ongoing usage/support/maintenance of a system from the start. At each phases (Analysis, Planning, Implementation, Go-Live…) there are different things that should be taken into consideration regarding ongoing plans once the project is live. Making those decisions up front is critical to uncover gaps, avoid poor adoption, insure that company gets the most out of their investment ongoing. This session will highlight these important items with a nice analogy to family life:

  • The Analysis phase is like finding your partner (system choice)– You should know why you are choosing AX and ensure that your goals are in sync.
  • The Planning phase is like thinking about what your family (implementation) might look like - including how many kids, cars, size of house needed, type of schooling, etc... (This relates to 3rd party add-ons, architecture, consulting/training/support.)
  • The Implementation phase starts off fun (cute babies and everyone is excited) and there is typically a lot of help available.
  • The Implementation phase then becomes challenging/overwhelming (when kids head off to school and have a lot of activities to balance).
  • Then the Implementation phase becomes hell - you have moody teenagers ready to graduate and head off to college, while, at some point, everyone hates everyone!
  • Finally we reach the Go-Live phase where everyone leaves and you are on your own.

Don't miss the chance to hear how all these things relate!

Merit Solutions Presenting Life Sciences Sessions at AXUG Summit

AXUG Summit is rapidly approaching and Merit Solutions is excited to be an exhibitor and presenter at this year's conference!

We are especially please to announce the Life Sciences track at AXUG Summit this year, with Merit Solutions and Valarie King-Bailey covering a wide range of topics relevant to Microsoft Dynamics AX Life Sciences companies. 

Here are the four AX Life Sciences track sessions:

Merit Solutions:

  • Microsoft Dynamics AX and the Sunshine Act: Fits, Gaps, and Real-World Applications - Thursday, October 16 from 4:45 - 6:00pm in Room 105
    The Physician Payment Sunshine Act requires all medical drug, device, and supply companies to report how much they spend with individual healthcare practitioners. This has caused an immense amount of activity for these Life Sciences companies because aggregating healthcare practitioner spend data is growing rapidly in terms of complexity and global adoption. In this session, we will discuss real-world applications of the Sunshine Act using Microsoft Dynamics AX – while diving into the fits, gaps, and solutions for complying with regulations and mitigating the risk associated with these investments.
  • UDI, DSCSA, and Microsoft Dynamics AX - Thursday, October 16 from 2:00 - 3:00pm in Room 102
    In an ongoing effort to mitigate the risks patients are exposed to when using medical devices and pharmaceutical drugs, the FDA has recently enacted two regulations for companies in these industries. Unique Device Identifier (UDI) regulations require most medical devices distributed in the United States to be documented and tracked. The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical companies to include product transaction information in an electronic or paper record every time ownership of the product or material is transferred. Underestimating the scope and scale of these regulations could put your company at risk. In this session, we will discuss real-world applications of UDI and DSCSA using Microsoft Dynamics AX – while diving into the fits, gaps, and solutions for complying with regulations and mitigating the risk associated with non-compliance. 

Valarie King-Bailey (OnShore Technology)

  • AX Validation Approaches: Maintaining the Validation State in a Cloud Computing Environment - Wednesday, October 15 from 1:00 - 2:00pm in Room 125
    This session will be a deep-dive and practical overview by subject matter experts with a focus on real life business challenges and solutions to help provide you with a thorough understanding of the software validation process as it relates to Microsoft Dynamics AX. This session will cover IQ/OQ/PQ and GAMP 5 applicability to the AX validation process. This session will also cover resource requirements, automated validation testing, maintaining the validated state and much more.
  • Green Validation: Paperless Validation Strategies For Microsoft Dynamics AX - Thursday, October 16 from 8:00 - 9:00am in Room 224
    Is paperless validation a reality? This session will cover the following topics regarding Dynamics AX validation: How you can initiate the validation activities early in an AX project; eliminate paper documentation and slow approval processes; reduce by 50% the time to completion by automating tasks, and maintain your AX systems in a validated state and inspection readiness. ⁞

Please join us for these great sessions - or stop by and see us in Booth 1301.

The Care and Feeding of a CAPA System

A robust CAPA system is sustained by sub systems that provide feedback into CAPA. There should be appropriate mechanisms in place to facilitate this flow of data. This is not a static system but rather a continuous loop. The risk becomes apparent when the CAPA loop remains unclosed. The result may be a CAPA that is opened for years or a CAPA that really didn’t fix the problem. The goal of continuing to collect data is to reduce the number of issues encountered as well as the severity of those that do occur.

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Getting Lean with ERP

Organizations of every kind want to get lean. Adding value, eliminating waste, and automating are some current buzzwords. ERP, on the other hand, is sometimes considered a necessary evil or even a creator of waste. But these two disciplines can get along quite nicely as complementary tools in our toolbox.

The best definitions of lean consider it to be an endless cycle. We identify value and define it in terms of value to our customer. We map the value stream; we identify all the activities that create value and place them along the stream of our processes. We create flows where our products and services move easily from one step to the next. We establish pulls; nothing is completed and passed along the stream until the downstream operation is ready to receive. We seek perfection, practicing every step until it is automatic and eliminating any unnecessary steps. Then we do it all over again.

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Job Opening: Microsoft Dynamics AX Financial Consultant

Merit Solutions is looking for an experienced Microsoft Dynamics AX 2012 Financial Consultant to join our growing team!

Working from home and traveling to our customer sites, the Microsoft Dynamics AX Financial Consultant will be part of our projects located on the West Coast, on occasion across the USA and potentially overseas. You will be reporting to Merit Solutions' Consulting Director.

As a consultant, you are tasked with lending your expertise to clients in need of insight. Our clients expect our consultants to view their business problems from a fresh perspective and to then act as the catalyst for change. Our consultants provide the objectivity and influence and excel at problem solving.

Learn more about this job opening: Microsoft Dynamics AX Financial Consultant.

Microsoft Dynamics AX Production Consultant Job Opening

Merit Solutions is currently looking for a Microsoft Dynamics AX Production Consultant to join our growing team!

Working from home and traveling to our customer sites, the Microsoft Dynamics AX Production Consultant will be part of our projects located on the West Coast, on occasion across the USA and potentially overseas. You will be reporting to Merit Solutions' Consulting Director.  

As a consultant, you are tasked with lending your expertise to clients in need of insight. Our clients expect our consultants to view their business problems from a fresh perspective and to then act as the catalyst for change. Our consultants provide the objectivity and influence and excel at problem solving.

Learn more about this job opening: Microsoft Dynamics AX Production Consultant.

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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