Planning your ERP journey: How to get there and stay compliant

What do ERP implementations and summer vacation have in common? Planning ahead of time will often save you time and money and help avoid last minute changes.

When you think about going on a journey, do you plan where to go?

If you phrase this in terms of taking a vacation, most people will say “yes, of course we choose a destination.”  

Now you might say, but Lasse what about a backpacking trip or going wherever the wind may take you? To that, I say sure – sometimes that is part of the charm to not have a plan. But there will always be some sort of constraint whether it be time, having cash, where you are allowed to go, etc.

In other words, you must have an outline to ensure your journey ends in the right place. Now that we understand that, I want to ask you about your digital journey. Surely you are on one, but have you planned that to the same extent as your travel? For Life Science companies, planning a digital transformation with a clear end goal is one of the most important aspects when it comes to ensuring future success for your business.

Your business has been storing documents and data for years. First it was likely paper-based and then on-prem. But now, many of us are moving to or are already in the cloud. Despite these changes, some aspects have remained the same:

  • Your IT solution must stay compliant
  • Related SOPs must cover all relevant aspects clearly and precisely
  • The solution must not only work for your data, but must also meet your business's ever-changing demands

But in many other ways, cloud solutions are an entirely different ball game. Unlike your previous on-premise system, with a cloud-based system you cannot be in full control of changes, releases, and functionality. Still, you must remain compliant.

Can we be compliant and not be in full control?

The first question I always get following this realization is: how can we be compliant if we are not in full control of our system? The short answer is yes, of course you can! Because in addition to planning, these new technological changes brought new ways of staying compliant.

Besides having a trusted vendor and partner, it is crucial that you start planning post-go live operational structures from the start of the project – even before implementation planning. This is a major shift in focus when it comes to ERP solutions. For many, implementing an ERP solution will be their largest IT investment. That means big changes and big decisions, so it may seem even logical to do things in order of occurrence (e.g., system selection -> implementation -> operational planning). However, it is just this type of roadmap that has left many Life Science companies having to make major changes to their system or have to rush to fix issues after go-live.

Instead of risking non-compliance, focus on the end target. By taking a look at the big picture, you can get a clearer idea of where you want to be in the end and the decisions that you need to take to get there. That is why at Epista we emphasize how important it is to look at your operational structures from the beginning.

I have worked with ERP solutions and Life Science for many years. And I believe that good results are often achieved not only from good planning and stakeholder involvement, but also with an investment in professional advice from an external partner. This extra investment could be the reason your system succeeds. As mentioned before, it is not that companies do not plan for operations, but rather they plan too late. The right partner knows to plan first and keep this end goal in focus throughout the entire process.

What should be considered first when starting to plan?

First, consider which skills your organization needs, which services are needed to stay compliant, and which kind of governance will support you best in order to meet your operational needs. These areas should be considered as early in the process as possible – that is why we advise our customers get a strong partner in before their project even begins. That way, we can use our experience and dialogue with the customer and implementation partner to make difficult decisions, build the most important services, and set up structures for validation.

In our experience, the most important services for Life Science companies are compliance management, change and release management, and service governance.

Compliance Management

Compliance Management is a collection of procedures and practices that reduces the risk of violating compliant, validations, and regulations. This includes what, where, and how to support IT solutions from the beginning all the way through ongoing operations. This service also handles IQ, OQ, and PQ and ensures that operational processes are supported by your SOPs. Additionally, compliance management makes sure that all relevant service providers are validated and able to deliver under the described terms of governance.

Change and Release Management

The change and release management service keeps track of all changes in your system and correctly handles any impact from GxP critical changes. It ensures that all changes are documented and tested before they are released to the operational environment.

Before each release, there are predefined processes that must be followed. Because cloud solution providers often have a structured way of informing customers about coming changes to the solution, change and release management helps by assessing all future changes and what needs to be done to keep your solution in a validated state.

Service Governance

Service governance creates a single point of contact where all the services required to maintain a modern cloud solution are taken care of. The reporting center is where major future changes will be planned according to your solution’s governance.

Other important services

In addition to the aforementioned three key services, there are others that may be needed to continuously ensure compliance. These include, but are not limited to, incident management, environment management, access management, and problem management. Most companies already have these services in place and mention them in their SOPs. So, they are not greatly affected by a digital transformation, and most can follow ITIL process.

Key Takeaway

By now, it should be clear that in order to get the most out of your IT investment, you need a plan in place. By planning early on, you can take the time to determine your need for structured services and to ensure that the selected services and providers are Life Science-focused. Providers with an industry focus will understand the need for continuously compliant solutions.

We know where we want our journey to end, but to get there, we also need to know where to start. Once we know that, we can concretely and efficiently plan out our investment. And, since we will know how to operate afterwards, leave more time to focus on the implementation and successfully enter a modern cloud-based solutions landscape.

If you need help planning your ERP journey, fill out the contact form below. I'd love to share my experience with you.

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Lasse Bruhn
Senior Vice President

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