This year we hosted more than 1,600 attendees at the Veeva R&D and Quality Summit Connect for a day of innovation, collaboration, and new product announcements.
In the regulatory track, more than a dozen Vault RIM customers shared their experiences and best practices for transforming regulatory operations. One of the highlights was a panel discussion with Recordati, GE Healthcare, and Mundipharma on how to get maximum benefit from a RIM solution. The panelists talked about harmonizing and streamlining regulatory processes; measuring and improving performance with KPIs; and the critical role of change management and data governance in realizing business value.
Faster Time-to-Market with Unified Processes
Emma Forrest, head of global R&D operations at Recordati, described their transition from siloed operations and outsourced services to a centralized, operationally efficient hub that manages submissions and other regulatory activities. By unifying regulatory processes, Recordati has accelerated the delivery of acquired products to market and saved more than a million dollars annually. Forrest stressed the role that KPIs have played in promoting the adoption and success of their Vault RIM implementation. 'It's critical to demonstrate that the system is making a difference to management, business heads, and operational teams,' she stated. 'They all benefit from seeing overall progress.'
New Metrics Enable Ongoing Efficiency Gains
James Hendry, head of global regulatory operations at GE Healthcare, shared his team's success driving business process improvements with monthly reporting on eight standard KPIs. For example, the organization is now 90% compliant with a 10-day target for communicating regulatory approvals, up from 40% when tracking started. GE Healthcare also prioritized data governance to increase the value derived from their RIM implementation. 'It's been put into everybody's top-level goals in the QRA organization to improve the quality of data in the Veeva system,' Hendry said. 'This system is the source of truth, so the data needs to be up-to-date and correct.'
Laying the Groundwork to Optimize RIM Performance
Mundipharma is at the beginning of a journey to harmonize and streamline regulatory processes across RX, CX, and local product portfolios. Helen Donnelly, head of RA systems and analytics, detailed the steps the company is taking to increase RIM value realization in the run-up to launch. These efforts include defining as-is and to-be processes, configuring the system to report and maximize efficiencies, and addressing 'the human element' of change management. 'We're driving that process and data ownership now, so by the time we go live with Veeva some of those behaviors are already embedded in the team,' Donnelly said.
Many thanks to our panelists for sharing their insights and experiences. To view this and other sessions from the Summit's regulatory track, please visit the Veeva R&D and Quality Summit Connect hub. If you'd like to learn more about how Veeva can help you get the most out of your RIM system, contact firstname.lastname@example.org.
Veeva Systems Inc. published this content on 16 June 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 June 2021 07:57:05 UTC.