Using the cloud in a validated environment: Controlling external governance

By now, you have most likely heard about the cloud, and you probably use it, too.

Do you access documents through Microsoft teams? Does your company use OneDrive? Do you wear a fitness tracker? All of these examples utilize the cloud and cloud storage to make data more secure and accessible. Still, there are plenty of places that have yet to make the change – especially in Pharma and Life Science, but why?

Because change is difficult to predict

Sometimes, you cannot plan for change. Maybe your IT system can no longer support the capacity of data or employees that your business requires or perhaps the system can no longer be kept in compliance. But what if everything is working “just fine”?

That’s the challenge. It is working just fine – for now. Before we know it, our on-prem systems will be out of date and there will be no new ones to buy. This means you will have to change your ways of working and because you know this now, you can plan for change – even though it is hard.

What changes can you expect from cloud-based systems?

Aside from the literal physical difference, the most immediate difference you will notice is that cloud operations will execute some tasks. Still, you are accountable. So, to put in controls for this, you will need to evaluate changes from two angles: compliance and IT.


In Life Science, we are used to ensuring compliance and validation internally. Especially now that some compliance activities are forcibly outsourced, we need to shift to a risk-based approach. By understanding any potential risks that may result from external activities, you can add appropriate controls like release cycles and roles and responsibilities to your procedures to make sure that you as the company can confidently maintain accountability.

When it comes to compliance, we understand that giving up control can be scary because we fear losing the thing that makes us comfortable: predictability. But remember who you are giving the control up to. These vendors know their systems better than anyone and some of them have been trusted IT solution providers for years. Why should that change now just because technology is evolving?


As clichéd as it is, Rome was not built in a day nor was it built by one man. Just like Rome, ERP systems encompass many different groups of people with different needs and all these stakeholders have various priorities and requirements, adding to the complexity of the system. This includes IT operations. They must also play a role in defining solid and efficient procedures that account for both internal and outsourced respomsibilites. Your IT operations will play a daily role in maintaining compliance. So, it is important that they understand the procedures that now include external participants.

To help ensure all required stakeholders are involved and that they understand each other consider bringing in a partner like Epista to help establish common understanding and insights so that everyone’s needs are being met and everyone succeeds.

The cloud is important for your future success

Even though many businesses still use on-premises systems, they are often not up to date and therefore will not allow your business to move forward. “According to IBM, on-premises infrastructure updates are often one of the first things toget pushed based on budget needs, project priority or unexpected disruptive events.”  

The cloud is here to stay. It not only helps eliminates the risk associated with delayed updates, but business functions like the cloud and want to implement it. So, you need to plan for it accordingly because in the near future – or sooner – the cloud will be the best choice for your success. 

There is no rule that says you must have your IT systems in the cloud. But if we know the Life Science industry (and we like to think we do!), then we know that your company likely wants to be at the forefront of the latest developments. Why not apply that to your technology as well?

Although forced updates and changes can be scary, you must remember that these changes are being installed so that your system can continue to run smoothly and efficiently, thereby ensuring that your business is doing the same. If you stay with an on-prem system or one with service that has run out, you risk losing data, not being in compliance, or worse case, having a system break down that can no longer be fixed. In summary, moving to the cloud is the best way to ensure that you are always compliant – now and in the future.

Have we convinced you about the cloud? Yes? Then your next step is implementation. The 3rd article in our always compliant series will dive into the phases of implementing a cloud-based ERP system.

Want more information about moving your business application to the cloud? We can help you ensure compliance and confidently adopt the latest technology. Get in touch with one of our experts at the contact link below.

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Lasse Bruhn
Senior Vice President

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