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.