RocketWheel - Veeva - "Veeva Vault RIM Suite" - RocketWheel Explainer Videos

This video provides an in-depth exploration of the challenges inherent in managing global regulatory information (RIM) and introduces the Veeva Vault RIM Suite as the solution for pharmaceutical and life sciences organizations. The presentation establishes the context by highlighting how supporting multiple markets makes regulatory information management highly complex. Everyday operational events, such as a manufacturing change or a health authority request, trigger extensive waves of necessary activities, including impact assessment, submission updates, and ensuring regional compliance across all affected territories.

The analysis contrasts the inefficiencies of the "typical process" with the integrated capabilities of the Veeva Vault platform. Historically, regulatory processes are fragmented, relying on a patchwork of disparate systems. A typical workflow involves checking headquarters registration tracking, requesting information from affiliates, aggregating data in a separate project tracker, managing authoring and reviews in one system, publishing in another, dispatching submissions, locally tracking agency responses, and finally storing the massive dossier in a basic file share. This fragmentation results in critical information silos, making compliance extremely challenging and global visibility nearly impossible due to technological limitations.

Veeva Vault RIM is presented as the technological evolution designed to eliminate these systemic issues by uniquely managing both content and data within a single, unified platform. This integration streamlines regulatory processes significantly. For example, a change event is now assessed within a global registration management system that directly links regulatory data to the original source documents. This ensures traceability and accuracy throughout the lifecycle. Furthermore, the system provides real-time tracking of submission documents and regulatory activities across all affected markets, offering one system for one comprehensive view across Regulatory departments globally. The ultimate goal is to enable organizations to move faster, gain critical visibility, and strengthen their overall compliance posture.

Key Takeaways: • Fragmentation is the Primary Barrier: The traditional regulatory process is severely hampered by the use of separate, non-integrated systems for tracking, scheduling, authoring, publishing, and storage, which creates information silos and hinders efficient global operations. • Trigger Events Demand Integrated Workflows: Common operational events, such as manufacturing changes or health authority requests, necessitate complex, multi-regional regulatory workflows that require a unified system to manage the cascade of necessary assessment and submission activities. • Compliance Risk from Poor Visibility: Relying on project trackers and basic file shares makes it nearly impossible to maintain real-time visibility into the status of submissions and regional compliance, significantly increasing the risk of regulatory non-adherence. • Veeva Vault RIM Unifies Content and Data: The core value proposition of the Veeva Vault RIM Suite is its unique ability to manage both regulatory content (documents) and regulatory data (registrations, commitments) within a single platform, effectively eliminating the information silos that plague legacy systems. • Global Registration Management: The suite centralizes the assessment of change events using a global registration management system, which is crucial for ensuring that regulatory data is consistently linked back to the original source documents for auditability and traceability. • Real-Time Tracking is Essential for Proactive Management: The system provides real-time tracking of submission documents and regulatory activities across all affected markets, enabling regulatory teams to proactively manage deadlines and respond quickly to agency requests. • Strengthening Regulatory Compliance: By offering a single source of truth and automating the linkage between regulatory data and content, the solution directly contributes to strengthening compliance with critical regulations (e.g., FDA, EMA, GxP). • Operational Efficiency Gains: Streamlining the end-to-end process—from initial impact assessment and authoring through to publishing, dispatch, and tracking—allows life sciences companies to accelerate regulatory timelines and reduce manual administrative burdens. • Single System for Global View: Veeva Vault RIM establishes a "one system for one view" paradigm, ensuring that all stakeholders, regardless of geographic location, are operating from the same, current regulatory information, which is vital for global commercial success.

Tools/Resources Mentioned:

• Veeva Vault RIM Suite
• Veeva Vault

Key Concepts:

• Regulatory Information Management (RIM): The comprehensive management of all data and documents related to regulatory submissions, product registrations, and compliance activities globally.
• Information Silos: The isolation of data and content within separate, non-communicating systems, which prevents a holistic view of regulatory status and compliance.
• Global Registration Management: The centralized process of tracking, updating, and managing product registrations and regulatory commitments across all international markets.
• Content and Data Integration: The ability of a single platform (Veeva Vault) to manage both the structured data (e.g., registration dates, market status) and the unstructured content (e.g., submission dossiers, source documents) simultaneously.