Microsoft Dynamics 365 in the heavily-regulated Pharma & Life Sciences industry: is it possible?

Of course, it can. Epista, our partner in compliancy and validation, believes Dynamics 365 Finance & Operations is well-built for pharma, biotech, and medical device manufacturers.  This article shares their knowledge on common challenges to help you plan for, validate, and get the maximum value out of your future-proofed ERP system. All while living up to the heavily regulated GxP requirements of Life Science.  

Challenge 1: Understand and align stakeholders for harmonized and future-proof processes

From the very beginning, your Dynamics 365 Finance & Operations project will have many diverse stakeholders. These include IT, Quality, and Business, as well as your implementation partner. The different stakeholders naturally focus on their own particular KPIs and goals. It’s important to understand them all from the very beginning of the project – even before starting system implementation. Including their future plans, so you design a system that actually scales with your company. If you achieve this challenging alignment, you’ll end up with harmonized processes and a validated system that supports your business, now and in the future. Not the other way around.  

Challenge 2: Select the tools that make it easier to validate your ERP system  

We’re often asked: “Are there any Life Science specific tools and add-ons for Dynamics 365 Finance & Operations?” The answer is yes, and it’s a jungle out there. Here are a few ways to ease the validation burden of Dynamics 365 FO:

• Microsoft Dynamics 365 Finance & Operations ISV Life Science accelerators. The market is growing for Microsoft Dynamics 365 Finance & Operations add-on products, and they’re being offered by several different vendors. The products tend to have the same basic functionality, with a few differences. These differences span functions like electronic signature solutions, built in LIMS systems, and approval workflows for critical system areas.  

TIP: When evaluating these accelerators, be sure to ask for a roadmap, as well as reference customers to ensure the tools fit into your specific line of business

• Automated Testing Tools. One way to maintain the validated state through frequent patches and upgrades is to automate testing. Microsoft offers the RSAT tool, a part of Azure DevOps. While robust in some areas, RSAT’s well-known limitation is the inability to test across applications and integrations.  
  
  
• Azure Devops add-ons. Azure DevOps is used extensively for Life Science ERP projects, both by partners and within project teams. There are a growing number of add-ons to support efforts to maintain the validated state. However, experience is required to structure DevOps correctly so you can retrieve much of the information needed for the validation report and traceability matrix directly via DevOps. When configured correctly, this is a huge time-saver.  
  
  

TIP: Remember to plan the DevOps structure in advance, so it is in place before the teams begin to provide information. Otherwise, if it’s not correct and needs to change, you’ll waste time cleaning up the data and establishing the correct references between the DevOps artifacts.

Challenge 3: Maintain the validated state through forced updates

Dynamics 365 Finance & Operations allows you to configure areas of the supply chain that will impact GxP requirements. This increases the effort required to maintain the validated state of your ERP system. The more custom configurations you create, the more testing the system will require. So, how can you stay compliant in these ever-shorter and more frequent innovation cycles? Consider alternatives such as paperless validation services that are aligned with the rapid changes in the cloud environment.

Challenge 4: Domain Expertise

You’re expert in your field, and your implementation partner should be an expert in ERP systems for the industry. Choose a partner with the domain expertise you need with deep knowledge of the GxP affected areas of the Microsoft stacks, a proven validation methodology that is fully integrated into the implementation approach and follows industry standards such as ISPE’s GAMP guidance. 

In conclusion: Pay attention to the GxP-related areas of your ERP system

As our discussion illustrates, GxP requirements infiltrate many different areas of an ERP project – manufacturing, distribution, pick and pack, batch releases, etc. There are a lot of different decisions to make so that, in the end, you have a system with well-functioning end-to-end processes.