Making the choice to improve your existing processes and ways of working is no small decision. Business applications like ERP systems can grow to play a role in nearly every part of a company. To prepare for this type of change, you must consider your needs, which system will best meet those needs, how you will implement the selected system, and how you will manage it during operations. At Epista, we call the steps in this process Needs Analysis & System Selection, Project Preparation, System Implementation, and Managed Operations. If you can successfully make it through the whole process to operations, you can be confident that your selected system will not only meet your business needs, but help you succeed beyond them. That is why, even though you may want to jump forward to implementation, it is important to really stop and consider your current organization.
In this stage, everything can seem very overwhelming. You might be asking yourself questions like: What do we want and need? Do we need a partner? Which system is best?
We will eventually answer all these questions, but first, you must understand the cloud environment your new system will be in. Many companies choose to approach this by listing all their needs, looking for something that can, theoretically, fit all areas, and implementing it. Do not do this. Inexperienced cloud vendors often recommend this “single” system approach and end up building custom solutions that are difficult to maintain, validate, and update. Before you know it, you’ll be writing custom workarounds and ending up right back where you started with a complex system that hinders your business.
Epista Expert: “If you only consider your business requirements and needs from your current point of view and experience, it doesn’t matter how great the business application is. You’ll end up in the same place you were in before you started. Challenge yourself.” – Henrik Walther Madsen, Director ERP
Instead, the best thing for Life Science companies is to select a system that not only meets industry standards, but also offers standard building blocks for you to design the best system for you. Why standard? Because it is easier to validate and in the Life Sciences compliance and validation are key. To find this best system for your business, you need a team that:
Now that you know what knowledge you need and how to approach your system, we can move onto considerations for your selection phase.
When it comes to the selection process, remember that you are not only choosing the system. You are also selecting a vendor, IT and validation procedures, and, if you want to do it right, a partner.
Ideally, you bring in a partner with industry knowledge from the start. That is because the right partner has the experience and industry knowledge to help you analyze your needs and pick a system and vendor that best fits your needs and meets industry requirements.
A key priority when choosing a system is to determine if your validation strategy and IT procedures are a good fit with the system. The only way to validate these systems is via the vendor’s validation and IT procedures. So, you will want (and need) to accommodate this in your ways of working. The better the match to your existing processes, the smoother the implementation. And if there are differences, which there will be some, you will be able to plan for them. If you select a system and vendor without taking this step, the mismatches will only lead to surprises and potential challenges down the road.
At this point, you have decided on a partner, system, vendor, and have made all the choices that come along with those decisions. It is at this stage that you will begin validation planning and initiation, defining processes for implementation, and ensuring everyone (IT, QA, and Line of Business) is on the same page. If needed, here you can also bring in external and partner resources, like Epista consultants, to fill the resource and knowledge gaps.
There are a lot of different implementation approaches out there. So many so that it can be difficult to choose the one that works best. But what if we said you don’t have to choose just one? Sometimes a combination can provide the best approach. ERP implementations are large and have a lot of moving parts, so we suggest agile and shift left approaches to make sure all your bases are covered AND you remain compliant.
If you want to get the most out of your system, you will need to adopt its processes for best practice. An agile implementation approach takes into consideration the fact that you will be adopting some of the system’s processes. At the start, you won’t know what you need. An agile approach allows you to learn over the course of the project and make changes based on system requirements and learnings. With so many potential changes, it is okay to not write the entire plan up front and adjust as you go.
That is not to say you shouldn’t plan at all. If you prepared properly, then you have at least a basic project plan in place. The shift left approach works with the agile approach to make changes as the project progresses. With this method, you refer to the project plan, test, and document as soon as a process is working. This allows you to make changes and improvements as you go rather than at the end. Additionally, when you begin the validation phase, you will know that the tests you must perform will pass since you have already tested them. This means saving time and ensuring higher quality.
Epista Expert: “Make sure you start assessing your documentation and testing as early in the project as possible. This way any setbacks or errors can be handled instead of piling up at surprising you at the end.” – Henrik Walther Madsen, Director ERP
Now that we have introduced you to implementation approaches, let us tell you a bit about the operational phase of your ERP system.
If you prepared properly during implementation, then you should be well prepared for operating your system with efficient and compliant procedures. However, this will be a bit more complex than with any previous on-premise system. In the cloud, you are no longer responsible for much of the maintenance, but you are still held accountable – even for actions taken by vendors.
For many companies, this is both a mental challenge and a knowledge challenge. It can be mentally challenging to let go of some tasks that the vendors will now take on. The knowledge challenge comes with designing ideal requirement specifications and procedures to help you work best with the cloud vendors. This is where we recommend bringing in external help to design and produce:
Bringing in external expertise can also help you begin to handle some areas you will want to handle internally but don’t yet have the competences for. Experts like our team at Epista can temporarily handle those and train your team to eventually take over. The most important part of an ERP implementation is ensuring that you set yourself up for success from the start so that you run into less obstacles in the future.
If you take one thing away from this article, it should be that the early stages of your ERP system implementation are key to the success of your system. Without proper planning and preparation, you are certain to run into unnecessary challenges and roadblocks that will only delay the process and add frustration for you and your team. Planning also prepares you for operating in a new environment. Learn more about managing the cloud in the second article in our always compliant series: Using the cloud in a validated environment.
With Epista, you can overcome these challenges by adding expertise in every phase from realizing your needs to selecting your software, partner, and vendor to helping you operate the system. Implementations are challenging, but they can and should lead to efficient, predictable, and compliant systems in the long run. If you’re ready to dive into your next implementation, Epista can help.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.