26
Feb

Free Webinar: Product Serialization and Tracing

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.

Join us for our next webinar in our Mastering Compliance and Innovation Life Sciences Executive Series:

Product Serialization and Tracing
Wednesday March 4, 2015
12:00pm Eastern (9:00am Pacific)

Register now for the Product Serialization and Tracing Webinar

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.

12
Feb

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.

Read more

5
Sep

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.