Streamlining Business Operations in Animal Health at Veeva R&D and Quality Summit Connect
At the Veeva R&D and Quality Summit Connect, we heard from two leading animal health companies, Elanco and Ecuphar, about RIM implementation planning and best practices. Both organizations view RIM implementation as more than just establishing a system, but rather an opportunity to transform and streamline global business operations.
In an interactive roundtable, Ben Strickland and Lieve Goossens from Elanco joined Luis Saavedra from Ecuphar to discuss how they were looking for an authoritative system for regulatory content, data, activities, and processes to improve data quality, integrity, and overall visibility. By bringing together regulatory submissions, application tracking, registration tracking, and dossier archiving into one platform, they now have a comprehensive view of regulatory approval status for marketed and investigational products alike.
Elanco went live with Vault Registrations, Vault Submissions, and Vault Submissions Archive in the fall of 2020, following a multi-year implementation to centralize and standardize the management of global regulatory information. With a large and diverse portfolio of products, they had various systems in place to manage regulatory content, data, and hand-offs to supply chain, manufacturing, and other critical functions involved in product development.
More recently, Ecuphar, a subsidiary of the international veterinary pharmaceutical and services business Animalcare Group plc, selected Vault Submissions and Vault Registrations to support their regulatory activities. In order to incorporate data from multiple acquisitions, Ecuphar wanted a common system and a standardized, effective way of working. They also needed a solution that would allow them to easily retrieve information and manage it in an efficient and compliant way to meet health authority requirements now and into the future. Ecuphar will start their Vault RIM implementation in the near future.
Lessons Learned and Looking Ahead
Both Elanco and Ecuphar emphasized how important it is to not underestimate the amount of effort that goes into a RIM implementation. Effective change management and continuous training are critical to the transition. In some cases, you may be changing processes that have been around for years, and that kind of evolution does not happen overnight. To get employees on board, it’s helpful to highlight the benefits in moving to a new system including improved data confidence, real-time visibility, and reduced manual effort to understand what products are approved in which markets.
To learn more about how organizations are incorporating change management into their regulatory transformation projects, read this blog post.