Of course, it can. At Epista, we believe Dynamics 365 FO is well-built for pharma, biotech, 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 for pharmaceutical, biotech, and medical device companies. All while living up to the heavily regulated GxP requirements of Life Science.
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.
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 The SOP was totally out of date in relation to the new technology and the company’s QMS did not match the actual implementation.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.
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:
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
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!
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.
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:
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.
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.
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:
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.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.
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