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Can Microsoft Dynamics 365 FO be used in heavily regulated Life Science?

For Pharma, Biotech, and Medical Device projects: Common challenges that come with implementing D365 - and their solutions

Of course, it can. At Epista, we believe Dynamics 365 FO is well-built for biotech, pharma, and medical device manufacturers.  This article shares our 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 FO 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.  

Communication between relevant stakeholders in a Life Science organization

Here’s an example of one medical device company that never aligned expectations between the Business and the Quality departments. All along, Quality was counting on signatures to be stored in a paper-based system, as their then-current QMS specified. The Business team naturally wanted to update to more modern technology, run all testing in Azure DevOps, and store the evidence from IQ, OQ, and PQ in the document management system, applying an electronic signature. And, the system was implemented in this way. The result? The SOP was totally out of date in relation to the new technology and the company’s QMS did not match the actual implementation. In the end, the electronic signatures were adopted and the QMS was updated. But this misunderstanding caused a level of bad will in the organization and created a major time delay in the project to restructure the testing and documentation process.

If you need assistance in this area, Epista has gained it over many years, through many ERP projects with many companies. We can help you analyze your current business processes and future business strategy. Then, we’ll hold workshops with the diverse stakeholders to design future-proof processes that are as standardized as possible, while also being optimized for your specific needs.

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 FO?” 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 FO ISV Life Science accelerators. The market is growing for Microsoft Dynamics 365 FO 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.  

TIP: At Epista, we have experience with several other well-functioning tools, have shortlisted the best ones, and have also validated the suppliers. Ask us!

  • 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 FO 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.

To illustrate, we’ll use another example, this time from a pharmaceutical company.  

They have a planned freeze period of eight weeks prior to a new release. Even with eight weeks, they often miss the deadline. There are a few root causes for this that lead to these delays:

  • Too many stakeholders, with an unclear RACI (responsibility assignment matrix).  
  • An unbalanced split between automated and manual testing.  
  • The ‘self-cure’ ability of many test tools is overrated.  

In the end, Epista helped the company keep, and even lower, the time-horizon per deployment. The solution was a combination of many changes. We changed their test-tool, enabling the client to automate testing across applications and reduce the number of manual tests needed. Also, we helped them lower the actual number of testcases, while at the same time increasing the process scope. Finally, we helped them find a better way to manage the test phases with improved test management, documentation and deployment procedures.  

Challenge 4: Domain Expertise

You’re expert in your field. We’re experts in ERP systems for Life Science. That fact is, most Life Science professionals are typically only involved in one or two ERP-implementations in their entire career. We work with these projects every day.  

Epista has developed a cost-effective validation approach for Microsoft Dynamics 365 FO for the Life Science industry. Our ‘Compliance as a Service’ gives you the domain expertise you need, efficiently. Many of our validation services are built with templates, so we’re up to speed quickly. We apply a risk-based approach using our deep knowledge of the GxP affected areas of the Microsoft stacks. Our Dynamics 365 FO validation methodology is fully integrated into the implementation approach and follows industry standards such as ISPE’s GAMP guidance. And yes, we can help you use Azure DevOps in a validated environment.  

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. Epista can act as a bridge between you and your system integrator, putting the right people in the right roles to help ensure the success of your project.

Over and above validation services, we are experts in application services, including IT-ERP architecture and how it can be configured to comply with GxP regulations:

  • IT-architecture based on deep industry domain knowledge
  • Configuration support (facilitate, support, ownership)
  • Subject matter expert (SME) to staff your project team, both as leaders and extra resources
  • GxP-Application support on Microsoft D365 and AX2012.
  • Roadmap analysis to determine relevance of new features, including advice on how to implement and benefit from them  
  • Advice on how to implement new technology from a business and compliance point of view.

We enjoy sharing our knowledge and are happy to discuss continuously improving compliance and business in your company. Get in touch if we can advise your Life Science company on how to maximize the value of your Dynamics 365 FO system. Specifically, reach out to Henrik Oxlund at hox@epista.com or complete the contact form below.

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Henrik Oxlund
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