XEDEV conducts formulation research for the pharmaceutical industry and produces small batches of drugs for clinical trials. The Zele-based company has grown tremendously in a short period of time and found the ideal business solution in the Microsoft Dynamics 365 Business Central ERP system. The expansion with Yaveon 365 for Business Central (formerly Probatch) guarantees that it can meet the high quality and production standards that are so characteristic of the pharmaceutical industry.
Yaveon 365, the solution that Alistar rolled out, meets all of our needs: from financial management to inventory management, and from production planning and logistics to controlling
Lieselotte De Smet, Chief Scientific Officer
XEDEV specializes in the development and small-scale production of solid-dose medications. Lieselotte explains how it works: “We usually start a project with formulation development. Clients come to us with an active molecule—such as acetaminophen—to which we then add excipients in a specific way to ensure that the molecule functions properly in the body. Simply put: we turn the active molecule ‘paracetamol’ into an actual drug—the proverbial ‘Dafalgan.’ In a second phase, we’ll actually start producing the formula so it can be used in clinical trials.”
From R&D to production, including batch inspections
A project always starts with us in the Research & Development department, where we develop the right formula. We handle this creative phase primarily outside the ERP system, but once the formula takes shape and clinical data is needed, the project is set up in Business Central and Yaveon. From that point on, we link all our activities related to that specific project in the ERP system. This way, we have a single source of truth, and all our departments—whether finance, R&D, or production—work together efficiently.
We use the production module, which links all the necessary raw materials and items to the project, and the scheduling tool that takes our production process into account. After that, the rest basically happens automatically. When you enter the final product into Yaveon, it quickly calculates how much and what you need to produce a specific quantity of that product. It also immediately orders everything you need through purchase proposals. This significantly reduces the need for manual tasks and thus saves a considerable amount of time.
The most important aspect of our ERP software's design is its various approval workflows.
Dynamics 365 and Yaveon help us work more efficiently and free up more time for our customers.
For example, we are not allowed to start production until a quality control employee has approved all raw materials. This means, for instance, that purchased raw materials delivered to us are inspected first. If they don’t get the green light, Business Central won’t allow us to start production either. In this way, the system helps us in all sorts of ways.
This applies not only upon receipt and during production, but also afterward. A manufactured drug cannot be shipped until we are certain of its quality. The product is therefore placed in quarantine status. Only after the quality control representative gives the go-ahead is it released and can it be shipped. Although everything must comply with strict procedures, this does not mean that exceptions are impossible. For example, our finished products are inspected by external companies. Samples can therefore be shipped for inspection. We can configure such exceptions in ProBatch, an add-on specifically designed for the process industry.
A robust WMS that takes compliance into account
Strict monitoring and documentation begin with inventory management: “We need to be able to track inventory precisely. We need to know where a product is located, who moved it, why it was moved, and so on. This is also important for our production: when we combine components A and B, a new lot number must be generated.”.
Compliance and approval are also a major hurdle: there isn’t a single step in the process that doesn’t require an approval workflow. We need to be able to restrict access to certain information for certain people. For example, warehouse staff are not allowed to make any changes. They also cannot pick products for production unless they are included in a production order. Numerous aspects really need to be properly restricted, and we need to carefully consider who can and is allowed to do what in the system.
A large portfolio and two very different departments
Because XEDEV works on such a wide variety of projects, they have a vast amount of knowledge. That’s also why clients turn to this East Flemish company. “Last year, we worked on about 106 projects—or 106 active molecules, to be precise. By comparison, large pharmaceutical companies typically have about ten molecules, which they then work on for ten years. To bring all those projects to a successful conclusion, we needed a robust ERP system. We reviewed all our processes, from R&D to production, and—together with the Alistar consultants—translated them into digital workflows and screens. That was a challenging task, but we’re now reaping the benefits more and more as we grow.”
“We’re dealing with highly creative research on one hand, and a fixed, almost rigid, production side on the other, where everything has to follow a set pattern and be perfectly documented. So those two departments have completely different mindsets and ways of working. Those two worlds occasionally collide when you want to standardize and implement ERP software,” Lieselotte says with a wink.
The biggest advantage of Yaveon 365 as an add-on for Business Central is that it is GMP-approved.
“We initially used Microsoft Dynamics 365 Business Central exclusively for invoicing. We then wanted to add batch controls and production to it as well. Our Dynamics partner at the time proposed a custom solution they had developed themselves. When we heard about Alistar and their expertise in the sector, as well as their experience with Yaveon 365, the decision to work with them was a no-brainer. The biggest advantage of this Business Central add-on was that it is GMP-approved, meaning it meets all requirements regarding quality management, traceability, batch management, and compliance with industrial and legal regulations. It also features compliance modules that ensure specific rules are set up. And all of this is combined with an ERP package that is as standard as possible, such as Business Central.”
Lieselotte warns, however: “It was very labor-intensive, and a lot was expected of us. We worked hard and thought carefully about exactly where we wanted to go. I strongly recommend that other companies embarking on a similar process set aside enough time and resources. You really have to take a proactive approach to it.”
So the project did take some effort, but according to Lieselotte, that also has its advantages: ‘We now understand our system very well ourselves. The Alistar consultant has also evolved alongside us, and we’ve grown together with him. It was a two-way process. His role was to challenge us, question us, hold up a mirror to us, and sometimes even temper our enthusiasm. All with the goal of making our business processes future-proof.”
