End to End Regulatory Information Management Case Study of a Veeva RIM Implementation

This. The discussion covers critical aspects like harmonizing global regulatory processes, managing data migration and integration from legacy systems, ensuring compliance, and navigating large-scale enterprise software adoption within the life sciences industry.

This video explores an end-to-end Veeva Regulatory Information Management (RIM) system implementation for a top 10 pharmaceutical company, transitioning from disparate legacy systems to a globally consistent solution. The speakers discuss the complexities of harmonizing processes and terminology across global teams managing regulatory, CMC, and safety submissions. The case study highlights a multi-year journey involving current state assessment, future state design, detailed requirements gathering, configuration, and phased rollout strategies. A key theme is the collaborative approach between the client, Astrix (the consulting firm), and Veeva, emphasizing strong program management, communication, and meticulous planning for process and data readiness, as well as user adoption in a highly regulated environment.

Key Takeaways:

• Complex Global Harmonization: Large pharmaceutical companies face significant challenges in harmonizing regulatory processes and terminology across global teams due to reliance on disparate legacy tools (spreadsheets, SharePoint, bespoke systems).
• Structured Multi-Workstream Approach: Successful large-scale implementations require a highly structured approach with dedicated workstreams for different functional areas (e.g., CMC, Safety, Regulatory, Authoring, Archive, Labeling), ensuring focused effort and expertise.
• Criticality of Process & Data Readiness: Meticulous assessment of current processes, definition of harmonized future states, alignment on terminology, and comprehensive data mapping, migration, and integration planning are fundamental to a successful RIM system rollout.
• Vendor Collaboration is Key: Direct and continuous collaboration with the software vendor (Veeva) is crucial for understanding system capabilities, best practices, configuration options, and leveraging product roadmaps for future enhancements.
• Comprehensive Change Management & Adoption: Effective user adoption plans, including stakeholder analysis, continuous communication (newsletters, intranet), and tailored training, are essential to manage the learning curve and ensure business continuity during phased rollouts.
• Navigating Implementation Hurdles: Common challenges include managing team member bandwidth, coordinating global time zones, addressing workstream dependencies, and adapting to system changes while maintaining ongoing critical operations and submission deadlines.
• Phased Rollout Strategy: An iterative, phased rollout, starting with core capabilities and gradually expanding scope based on system readiness, legacy constraints, and business continuity, is an effective strategy for managing large-scale enterprise software implementations.