Enterprise Resource Planning (ERP) systems are an integral part of many processes in the Life Science businesses. Yet, even as their importance grows, implementing and maintaining such complex systems still requires in-depth industry and system knowledge. In this article, we discuss four elements required for a successful ERP implementation.
This includes understanding processes, industry accelerators, system validation, and how to maintain the validated state during operations. By ensuring these elements are in place, businesses can set themselves up for success and be prepared for the future.
When it comes to implementing and maintaining an advanced IT system, you must think beyond the "basic" system steps. This is because, when applied correctly, an ERP system should be a part of your everyday processes.
That means that you, your team, your company, AND all other stakeholders (vendors, partners, etc.) must have a clear understanding of your current business processes. For the Life Science industry, it is necessary that you and all your stakeholders not only have deep process understanding of your company, but also of all the complexities of the Life Science industry - e.g., GMP; functional requirements, regulations, etc.
Clear process understanding leads to a successful and holistic ERP system.
By nature, ERP systems are complex. That means that a standard or "out-of-the-box" ERP system should be able to meet a business's bare minimum needs. But in regulated industries like Life Science, businesses often need more to ensure that both their ERP system and their company meets industry requirements - both now and in the future.
That is where industry accelerators come in. Industry accelerators help companies work better, more efficiently, and in compliance. Let's take Cegeka as an example. With the strong base of Dynamics 365, Cegeka's tool adds industry specific expertise, user-friendly functionalities, and the capability to manage necessary industry areas such as electronic signatures, supply chain, production, and more.
With the right industry accelerators, you can build an ERP system that helps you turn industry obstacles into smooth processes and opportunities.
After preparing and optimizing your ERP system and its processes, there is one more step before you can confidently go live. That is that you have to validate your ERP system. A successful ERP system plays a role in company processes from start to finish. In the Life Science industry, any GxP system that is involved with the product must be in compliance with regulatory requirements and industry standards.
To follow these guidelines, Pharma and Life Science companies must validated their ERP systems. Failure to validate your system will result in challenges from regulatory bodies like the EMA and FDA including costly penalties, fines, production delays, and more. By validating your ERP system, you help to ensure that your company avoids these complications. Having a validated ERP system also demonstrates trustworthy and reliable data. And maintaining a continuously validated system will make it easier to ensure that forced updates and changes are supported.
Maintaining the validated state of an ERP system is equally as important as the initial validation. This is because the second a system falls out of validation; it becomes at risk for falling out of compliance and of no longer complying with industry requirements. Strategically ensuring an always compliant and validated ERP system requires 4 elements.
The fourth element is perhaps the most important at this stage in the life of an ERP system. The right partner and/or managed operations team will understand the strict regulations and intricacies of the Life Science industry AND your selected ERP system. They will make sure that business can continue as usual in parallel with continuous forced releases, updates, and regulatory changes.
ERP systems are complicated networks with a lot of working parts. In order to be successful, these systems need to be approached with a holistic view so that each business area's needs are taken into consideration. On top of internal needs, ERP systems in Pharma and Life Science must also meet a whole host of external industry and regulatory requirements.
That being said, if you are implementing an ERP system, it is possible to avoid post-go live headaches caused by an incomplete implementation strategy. Between you, your system vendor, and your implementation partner, there should be deep understanding of the selected system, any add-ons or accelerators, validation requirements, and a set plan once the ERP system is operational. By ensuring this, you are preparing yourself, your company, and your ERP system for continued success through future changes and growth.
Whether you're deciding you need an ERP system, preparing to validate, or even go-live, Epista Life Science has the knowledge and experience to support your Life Science company. Our experts work with every step of the ERP implementation process from selection to maintenance and can fill knowledge gaps as needed. Get in touch to learn more about where Epista fits into your ERP implementation puzzle.
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