argenx is transitioning to a fully commercial company. So, they needed easy access to data, fast internationalization, and operational efficiency.
“I am happy to tell you that this implementation was a success. Great collaboration - we finished this project as one, perfect team.”
argenx creates life-changing immunology solutions. They’re one of Epista’s clients driving innovations that improve health care for society around the world. What started out as a small company focused on discovery and research, has grown exponentially and is on the way to becoming a full end-to-end commercial organization. In the process, argenx needed an integrated IT landscape to handle all their business-critical information. With Epista’s help, argenx began implementing the Veeva Development Cloud – including QualityDocs, Submission, eTMF, and QMS. The first crucial steppingstone being the implementation of Veeva QualityDocs.
Business needs are complex, and so are the technologies that support them. The challenge is that phrasing business requirements and translating them into a configuration that ensures the system supports operation and not vice versa takes time. This is why knowing when to make which decision is critical for success.
Starting with the right project methodology eliminates barriers and ensures no time is wasted. To get to market in the shortest possible time – and be prepared for the future – argenx needed easy access to data, fast internationalization, and operational efficiency.
To achieve this, Epista scoped the project by distributing questionnaires to relevant functional areas within argenx to get details on their use of documents and data. This exercise gave the project team an understanding of what documents existed in the business and who would benefit from using Veeva QualityDocs to manage them. Once the team evaluated those business needs, they met with key stakeholders and business process owners to define the preliminary scope of documents to be included in the initial system setup.
Once the team defined the preliminary scope, they examined details of related business processes. They interviewed process owners to learn about their vision for the future and drilled down into the way these processes were currently set up, which parts worked well, and which parts didn’t. Analyzing this information, Epista combined it with our proven methodologies to develop a roadmap to guide process changes and set implementation priorities. This provided a realistic planning timeline, an overview of how existing processes match the out-of-the-box Veeva configuration, and most importantly, the business needs that must be met after GO LIVE of Veeva QualityDocs. After these steps, the team could now define the best implementation approach and set realistic expectations.
The core of every Veeva implementation is the configuration phase. Here, argenx participated in the standard workshops with Veeva consultants to configure the solution before moving into the validation stage. Epista then took the configuration phase one step further by adding “homework sessions”. By introducing these interactive, guided sessions, Epista helped the subject-matter-experts not only get to know the system, but also to translate their needs into configuration requirements. The information gathered in the Phase 0 interviews helped to guide the discussions and focus on business-critical decisions. In addition, and, maybe most importantly, Epista helped argenx to challenge some of their decisions, to allow for the implementation of a system that supports the “to be” rather than the “as is”.
By generating detailed specifications along the way, these homework workshops allowed Epista to continuously provide feedback to the Veeva team. This helped to ensure that argenx’s new system could be accurately and efficiently configured, thereby quickly reaching the configuration lock and GO LIVE.
All projects have challenges – this one being no exception! There were a few areas to address to make to this implementation project successful.
Just as selecting the right system for your organization can be a difficult decision, getting the implementation approach right is imperative to a successful project. At argenx, the solution to this challenge was to think of the implementation group as one, united team made up of three different partners – argenx, Epista, and Veeva. This created a fully integrated team with no ‘us’ and ‘them’ philosophy.
From the start of the project, it was clear that the Business GO-LIVE timeline lined up with argenx’ first FDA preapproval inspection. This meant that, due to the incoming presence of an inspector, there would be no time for corrections. Every aspect of the implementation had to be ready for inspection right away. This also mean that the migration of all procedural documents and CSV documents was a priority, along with having as many other document types established as possible.
In addition to being inspection ready, it was also imperative that the project ended with strong user acceptance. During its rapid growth, argenx expanded to nearly 500 employees in three countries - all of which needed to use QualityDocs after implementation. This means two things:
Just because argenx implemented one new system, didn’t mean that they were replacing all their existing systems. In this case, argenx planned on keeping its training tool. That meant that everything done in QualityDocs, as well as all SOPs, needed to be integrated with the training tool. Along with their training tool, argenx had already implemented Veeva eTMF and Veeva Submissions, and they plan on implementing more vaults as they continue with their commercial transition. The main challenge is to maintain one single source of truth. To do this, each document had to indicate, very clearly, which vault it originated from and which vaults cross-reference it.
argenx was already live with two Veeva Vaults. So, many platform-based validation activities had already been done. It was important to ensure there was no duplication of effort. The best way to optimize the effort was to centrally set up the validation for general platform functionalities and supplement application-specific validations for eTMF, Submissions, and QualityDocs. This made validation, release management, change management, and post-GO LIVE managed operations easier for everyone involved.
Even by the high standards set for inspection readiness, user acceptance, existing system integration, and LEAN validation, the Veeva QualityDocs implementation at argenx was a success. It went live on the planned date, within budget, and without compromises on the agreed scope.
“In addition to leveraging partnerships, another important value at argenx is to always be open to improvement,” says Sofie Van den Abeele, QA Associate and QMS Lead at argenx. After the QualityDocs implementation project, Sophie reflected on a few lessons learned.
The better prepared you are, the better the project will proceed. That’s why advance planning, over and above general planning, is imperative. Make sure that you create a team with the right composition early on and create realistic timelines with achievable target dates. A good team includes flexible people with a can-do attitude and the right subject matter expertise. And a realistic timeline puts you in the right mindset for completing the project effectively and efficiently.
It is better to communicate short pieces of information frequently over the course of the project than to make one overwhelming communication at the end. By communicating during the implementation, you receive feedback and can make proactive changes rather than act retroactively.
The number one piece of advice here is to not underestimate the test phase. If your user acceptance tests go poorly, it could lead to many unnecessary changes. Make sure that you have a platform for training and support in place during the test phase. In addition, make sure there is enough time for stakeholders to test in the sandbox environment so that, as with your user acceptance tests, you can proactively make changes where needed.
Plan ahead. Ensure the training strategy is clear from the start of the implementation project – rather than being tacked on as an afterthought at the end.
argenx is in the middle of major organizational changes as they transition from research to a full end-to-end commercial company. A huge factor in this transition is the implementation of new procedures, processes, and IT systems that will support their exponential growth and development.
Currently, argenx is in the process of implementing five Veeva Vaults over five quarters. This massive and necessary undertaking for the company is why they chose to work with Epista as their implementation partner. argenx, Epista, and Veeva worked closely together to ensure a smooth and successful QualityDocs implementation. “I am happy to tell you that this implementation was a success. And this was only thanks to the great collaboration between Epista, argenx, and Veeva. We finished this project as one, perfect team,” says Sofie. argenx is now well on their way to becoming a fully commercial operation and Epista will be there for the next Vault implementation, Managed Operations, and more – every step of the way.
*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR.
We are dedicated to continuously improving compliance and business. And by turning compliance obstacles into business opportunities, we believe that we can help your Life Science company achieve its goals - quickly and efficiently.
We enjoy sharing our knowledge. Get in touch to find out how Epista can add value to your Life Science company.