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D365, Power Platform & MR

How to leverage Microsoft Power Platform while remaining GxP compliant

- Sam Laermans, Head of Digital Solutions, Life Sciences Advisory & Consulting, & Johannes Riis, Managing Specialist and Architect, NNIT

The wide range of low-code apps on the Microsoft Power Platform has made advanced technology available for practically everyone in life sciences and production. But how do you ensure GxP Compliance on a platform that democratizes development to everyone?

Today, many large life science organizations use the Microsoft Power Platform to build powerful low-code apps, build BI reports, and automate basic tasks. These improved workflows relieve the load on the IT department and create efficiency in an increasingly competitive market. However, without proper data governance and guidelines, the use of the Power Platform can present a challenge when it comes to GxP compliance.

The extensive toolbox available when using the Microsoft Power Platform enables more employees to manage manual processes, data and documents so that they can build dashboards or develop new applications harnessing AI or interfacing with external data sources. This can accelerate the journey toward paperless production, or help you move away from manual tracking to a Batch Release Dashboard that eliminates time-consuming manual work.

- In a sense, the Microsoft Power Platform has given everyone in the workplace a hammer and a box of nails. This makes problem-solving extremely efficient. But many organizations are now realizing that they need a new set of processes to know exactly where, when, and by whom the nails are being hammered, and to make sure GxP compliance is not jeopardized, says Sam Laermans, Head of Digital Solutions, Life Sciences Advisory & Consulting at NNIT. He elaborates:

– Any employee with a Microsoft Office 365 license can, as far the license type allows it, pull information from all over the organization and create customized apps that automate workflows and create immense value. But when no proper data governance is in place to control these apps, there is no way to prove to auditors that you are compliant with GxP regulations like 21 CFR part 11.

- When no proper data governance is in place to control these apps, there is no way to prove to auditors that you are compliant with GxP regulations.

Sam Laermans, Head of Digital Solutions,

Life Sciences Advisory & Consulting, NNIT

Digital systems must be validated

Having a strong governance structure in place to ensure that data and applications are used appropriately and responsibly is an essential prerequisite for accelerating digital transformation. However, the complexity of ensuring proper validation increases as development is democratized.

– A digital system that impacts product quality or safety must be validated to ensure that it does not pose a risk. This requires outstanding validation processes, says Johannes Riis, Managing Specialist and Architect at NNIT.

– You need to set up guardrails that make sure every step of the process is validated, tested, and documented. This can be a daunting task, but with NNIT’s deep life science experiences and in close collaboration with Microsoft we can ensure your digitalized processes remain GxP compliant.

3 tips: Take control of Microsoft Power Platform

1. Face the issue
In an environment of scarce IT resources and high demands for development, the future requires low-code apps. That is why large organizations opt for the Microsoft Power Platform. But many organizations have not yet taken the correct action to ensure GxP validation of the platform. The first step to solving this problem is acknowledging that a higher rate of efficiency requires a fair amount of red tape.

2. Delegate general responsibility
The Microsoft Power Platform is a massive foundation running throughout the organization, with multiple apps, AI and integration capabilities. To control all these capabilities, one function must oversee the horizontal governance of the platform. It is pivotal to find ownership in your organization that is capable to understand what it takes to continuously manage the GxP compliance of the Microsoft Power Platform.

3. Create a governance model
Imagine one of your process engineers finds a process that can be automated with low-code tools. The engineer creates a low-code application for the problem, but how do you manage, test, and continuously validate this application? You guessed it: by putting into place strict rules for how to own, develop, document, label and manage the life cycle of the app. Having robust governance procedures on the Power Platform is the only way to assure auditors that you are GxP compliant.

How can NNIT help?

NNIT helps the life science industry become compliant with regulations while improving efficiency. If you collaborate with NNIT on developing GxP-related processes for the Microsoft Power Platform, your business will have a dedicated team consisting of business or product owners from your business and specialists from NNIT.

– We’re connecting our specialists with your specialists to decide how we can assist you best with your Microsoft Power Platform. Both when it comes to platform adoption and governance models for your low-code apps, says Johannes Riis.

Feel free to contact us for more information on how we can help you define your business needs and ensure GxP compliance on the Microsoft Power Platform.