Merit Solutions will be presenting two sessions at AXUG Summit next month related to Microsoft Dynamics AX for Life Sciences companies. If you are attending AXUG Summit – be sure to register for these two sessions.
Project Management should be a key component of any ERP system implementation or upgrade. However, in highly regulated industries like Life Sciences, it is a critical must-have. During this session we will examine the value of using project management methodologies and tools when implementing a computerized system validation project with Microsoft Dynamics AX. This session will compare multiple Implementation Methodologies (including Sure Step), and discuss the use of SharePoint Project Sites and Microsofts LCS platform as tools for Microsoft Dynamics AX implementations.
Join us for this AXUG Life Sciences Session as we describe the importance of Document Management in highly regulated environments and requirements that should be considered within your controlled business processes, such as GxP, Computerized Systems, Standard Operating Procedures, and more. We will examine Document Management workflow processes that may require 21 CFR Part 11 compliance, as well as consider Document Management integration points with Microsoft Dynamics AX.
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.
Merit Solutions was happy to host the first webinar for AXUG’s Life Sciences Special Interest Group.
In many Life Sciences organizations, functions are spread across multiple business systems. For example, sales teams work in Salesforce.com, logistics works in Microsoft Dynamics AX, and quality tracks their documents in an external Quality Management or Document system.
Join us to learn about the pitfalls of this approach, and what the ideal integration strategies are for handling data that has multiple touch points, such as:
If you are in the Life Sciences industry and you missed this meeting, you missed a great session! No worries though because we recorded it for you so that you are able to view and not miss out on the great knowledge that was shared!
Download the on-demand webinar: Integrating Microsoft Dynamics AX into a "Hybrid" QMS Environment.
A very common audit observation is not following procedures. 23% of quality related warning letters issued by the FDA in 2013 were for document controls. The lions share of these issues involved the use of documents that do not follow the process. An auditor may notice a gap while reviewing document controls, reviewing executed records, during direct observation of your process or through questioning of operators. They may also probe multiple operators to establish consistency.
Some managers may have a false sense of confidence in thinking that Were O.K. We have a procedure for that. Yes you can certainly be cited for having no procedure at all. But you have to look at the adequacy of the procedures to the purpose and scope. The CFR requirements are specific. Documents should be clear and easy to follow. Changes have to be documented, reviewed and approved. Communication of a change and evidence of training must be documented.