Veeva Quality Improvement Assessment

Optimizing Bilthoven Biologicals' document management system


With their new Veeva Quality Suite, BBio initially implemented legacy procedures. While this worked for the time being, it proved inefficient.


Epista delivered an improvement project roadmap detailing improvement scope and priorities for an improved Veeva setup.


As a biopharma focused on vaccines, Bilthoven Biologicals (BBio) works every day on ensuring they deliver their promise of making vaccines for a better world. When it comes to producing medication, regulations require the maintenance of very high standards. For BBio, that meant finding a partner to help them meet some of these requirements. With Epista, BBio created both a more seamless end-user adoption and a more efficient QMS.

About Bilthoven Biologicals

Bilthoven Biologicals is a Netherlands-based biopharmaceutical company producing important vaccines for the treatment of illnesses like Tetanus, Polio, and more. As a part of the world's largest vaccine producer, Cyrus Poonawalla, Bilthoven Biologicals works hard every day to increase the positive impact of Life Science on society. Their hard work and dedication to the industry shows consistently, and even more recently with BBio's recent selection for a pandemic preparedness contract by the European Commission.

An Opportunity for Improvement

To continue to produce vaccines at the highest quality, BBio made the decision to upgrade their document management system to Veeva QualityDocs - a Life Science-focused system that helps to reduce compliance risk and improve quality processes. After the initial implementation, BBio experienced friction between their established ways of working and Veeva System’s document structure. That meant that they had to make some compromises with their Veeva system. However, for Veeva to work best, you should ideally follow Veeva’s recommendations. So, even though the implementation in and of itself proved successful, business processes seemed to not have improved as hoped because BBio adopted much of their proven legacy structure into Veeva.

In this case, the team felt that there was still more potential in their new Veeva product. So, after self-maintaining QualityDocs for about a year, Bilthoven Biologicals approached Epista to discuss how Epista could help them both improve existing structures and better manage Veeva Vault in the long run.

System Challenges & Room for Potential

Taking a step back, implementing Veeva QualityDocs was already a great first step in improving the quality of how BBio managed documentation. However, adopting a new system will always come with growing pains. In this case, BBio experienced these growing pains in the form of document structuring, user adoption, and the ability to locate documentation.

Initially, this may come across as a negative – think, "Oh no, we have to fix our QMS". But BBio was positive. Instead of seeing this as an error, they saw it as an opportunity to make their good system even better. This is where they decided to involve Epista. In fact, it was the collaboration between the BBio and Epista that shifted the attitude and opened up the floor for stepping back, questioning existing practices, and truly looking at how they could optimize their ways of working.

Enhancing Veeva QualityDocs

Bilthoven Biologicals invited 3 Epista consultants, Tzong-Yuan Lin, Anne Bielefeldt, and Rune Meijer, to come in and take a look at their current QualityDocs setup. After a first look, the Epista team came to BBio with the following conclusions and suggestions:

• The current setup was not bad, but better decisions could have been made during implementation

• BBio had a new system, but by adopting legacy structuring, previous ways of working remained intact

• They should consider taking a second look at document structure

• By adapting the latest standard workflows for their documentation, many of the existing roles and responsibilities – as well as training – were now being addressed

• By executing on their backlog, BBio was now able to resolve many minor issues in shorter periods of time

Mindset for Change: The critical success factor

Change is hard. Without the willingness for and the drive to change, it can become impossible to complete a project like this one at BBio - especially since they had experienced big change recently with the QualityDocs implementation. But this was not a problem at here.

Their team already had the right mindset. Martijn Huijbreghs, Business Intelligence Specialist at Bilthoven Biologicals, and Natasja Dros, Application Manager, jumped into this project with a solution-oriented and “ready-for-change" outlook. If it were not for this desire for improvement, the project would have needed a much stronger push from those in charge.

Solution: Restructuring, Guidance, and System Management

After determining where BBio could make improvements, Epista helped them get started on the changes. To ensure this project would give BBio the best document structure for their QMS, the Epista team ran a one-and-a-half-day workshop. In this workshop, we

• Included all relevant stakeholders

• Looked at and challenged current and future requirements

• Determined how these requirements could fit into the best structure for Veeva QualityDocs

• Focused on creating measurable results

• Reviewed and applied industry and system best practices

• Provided options and suggestions for moving forward with system improvement

After a productive and insightful on-site workshop, Epista delivered an improvement project roadmap for BBio. This roadmap detailed improvement scope and priorities, so that BBio could gather a better understanding of just what needed to be done and when.

What now?

After the Veeva Quality Suite assessment, Epista and Bilthoven Biologicals continue to work together. Both groups know all too well that improvement is an ongoing process. And after a strong collaboration, we decided to maintain our collaboration through a Managed Operations agreement.

As for Bilthoven Biological's QMS, Epista listened to end users and provided BBio implemented a variety of user-suggested improvements such as updating the application of scope on existing documents, updating meta fields, finetuning automated jobs, and more. In addition, the workshops and advisory provided BBio with suggestions for industry best practices to help them realize further potential of their new IT system.

“The collaboration with Epista can be described as very pleasant, constructive and productive. Their experience and knowledge forces us to challenge our requirements which results in realistic solutions that add real value to the business.” – Martin Huijbreghs, Business Intelligence Specialist

At Epista, we strive for continuous improvement - for ourselves and for our clients. Our consultants have experience with a variety of ECM and ERP systems and are constantly challenging common ways of working to see how the Life Science industry and be even more innovative, efficient, and compliant. Are you realizing the full potential of your IT system? If you think there is room for improvement, get in touch. We would love to see how we can work together.

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*Footnote: After May 26, 2024, medical devices registered under MDD will have to re-register under MDR. 

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Rune Meijer
Principal Consultant

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