bioMérieux, a leading IVD company with over 60 years of expertise across 160+ countries, faced a critical regulatory challenge. With a portfolio of approximately 1,500 IVDs and 1,400 industry devices, their outdated RIM tool and disconnected systems struggled to keep pace with rapid and increasing global changes. bioMérieux turned to Veeva Vault RIM to unify their global regulatory affairs, with a rapid deployment that took just 10 months.
Prior to the implementation, bioMérieux relied on fragmented legacy systems from 2017, leading to what Marie-Pierre Le Montagner, senior director of regulatory affairs for the lifecycle management team, described as “seven years of frustration, seven years of cleansing, seven years of difficulty”.
Manual processes and data inconsistencies delayed their progress, as regulatory stakeholders had to maintain the same information in multiple places across a complex tool architecture.
bioMérieux set out to find a new regulatory solution that would not only solve their existing challenges but also provide a foundation for future growth. To achieve this, they laid out four key objectives:
Guided by Marie-Pierre Le Montagner and regulatory affairs project leader, Florian Mesnil, the bioMérieux team executed an aggressive 10-month implementation timeline that relied on integration by design and a process-first configuration. By placing Veeva RIM at the center of their IT landscape, they ensured that data moved seamlessly between their master data management, ERP, and change management tool. They also mirrored their business processes in the new system, streamlining operations where relevant.
Organizational change management and communication were front and center throughout the project to engage the entire regulatory affairs group in this transformation. Leading up to the launch, a dedicated team delivered monthly presentations and early sandbox demos to familiarize users with the interface and vocabulary. They also tailored 10 different e-learning modules and hosted mandatory classroom training to get everyone on the same page.
Reflecting on the project, Marie-Pierre Le Montagner shared that, “We won back 50% of our time to track information related to change management.” They also gained unprecedented visibility into regulatory activities and reduced lead times with an interface that updates product status in 15 minutes, rather than the previous six-hour timeline.
Within a few months after launch, bioMérieux measured user satisfaction at 4.5 out of 5 and by the six-month mark, they had tracked over 35,000 activities in the new system. The high user satisfaction and adoption rates translated to tangible savings, which converted even the most outspoken project detractors and drew positive feedback from global regulators.
bioMérieux credits its success to a few critical factors:
Lastly, bioMérieux spoke to the strong collaboration with Veeva MedTech, which balanced flexibility with the company’s unique needs. As Florian Mesnil described, “Sometimes we adapted to what Veeva’s team said, sometimes we pushed to do things a little bit differently compared to other companies. But I think in the end, we really have what we wanted.”
To learn more about how bioMérieux transformed their regulatory processes with a unified RIM solution, watch this video.