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 Sam Laermans, Head of Digital Advisory 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 Sam Laermans.
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.