Veeva Vault RIM

This video provides an in-depth exploration of the challenges inherent in traditional Regulatory Information Management (RIM) within the life sciences industry and introduces the Veeva Vault RIM suite as a unified solution to these complexities. The presentation begins by establishing that managing regulatory information is incredibly difficult, particularly when supporting multiple global markets. It highlights how routine events, such as a manufacturing change or a health authority request, trigger extensive, necessary activities—including impact assessments, submission updates, and ensuring regional compliance—all of which are complicated by fragmented, disjointed regulatory systems.

The video details the typical, inefficient process for managing a product-related change. This process necessitates conducting regulatory impact assessments by checking headquarters' registration tracking systems, requesting information from global affiliates via calls or emails, and then aggregating this data into a separate project tracker. Subsequent steps involve managing submission authoring and reviews in one system, exporting content to another system for publishing, dispatching the submission, updating multiple trackers with health authority responses, and finally storing the completed dossier in a separate repository or file share. The core problem identified is that with planning, execution, and tracking residing in separate, non-integrated systems, compliance becomes challenging and achieving end-to-end visibility is nearly impossible.

Veeva Vault RIM is presented as the transformative solution that unifies regulatory documents and data onto a single, cloud-based platform. This consolidation is designed to eliminate information silos and streamline regulatory processes globally. By moving to this unified system, regulatory teams gain access to real-time tracking for all submission documents and regulatory activities across every affected market, ensuring consistency and accelerating workflows.

The Vault RIM suite is composed of several integrated applications, each addressing a critical component of the regulatory lifecycle. Vault Registrations manages global product registration data; Vault Submissions streamlines the entire process from planning to collaborative authoring and final approval; Vault Submissions Publishing automatically validates and publishes dossiers for distribution to health authorities; and Vault Submissions Archive securely stores and provides viewing access to the complete history of submissions in the cloud. This integrated approach ensures that organizations have one system providing comprehensive insight into global regulatory information and activities, enabling them to move faster, improve visibility, and strengthen overall compliance.

Key Takeaways: • Fragmentation Drives Compliance Risk: The traditional regulatory process is characterized by the use of multiple, separate systems for tracking, authoring, publishing, and archiving. This disjointed nature makes maintaining compliance difficult and prevents end-to-end visibility into global regulatory status. • Complexity of Routine Events: Even common occurrences like a manufacturing change or a health authority request trigger complex, multi-step regulatory workflows that require coordination across headquarters and affiliates, often relying on manual follow-up via calls and emails. • Unification as a Core Value Proposition: Veeva Vault RIM’s primary benefit is eliminating information silos by unifying all regulatory documents and data onto a single, cloud-based platform, thereby simplifying complex global processes. • Real-Time Global Activity Tracking: The platform provides regulatory teams with the ability to track submission documents and regulatory activities in real-time across all affected global markets, which is crucial for managing international compliance obligations. • Dedicated Registration Management: Vault Registrations serves as the centralized system for managing all global product registration data, ensuring a single source of truth regarding product status and regulatory requirements worldwide. • Streamlining Submission Workflows: Vault Submissions integrates planning, collaborative authoring, and approval processes, replacing the need for separate project trackers and review systems and accelerating the time required to prepare regulatory filings. • Automated Publishing and Validation: Vault Submissions Publishing automates the technical aspects of dossier preparation, including validation, ensuring that submissions are compliant with health authority specifications prior to distribution. • Secure, Integrated Archiving: Vault Submissions Archive provides secure, cloud-based storage for the complete submission history (the final dossier), ensuring long-term accessibility and adherence to regulatory requirements for records management. • Integrated IDMP Readiness: The Veeva Vault RIM suite is noted to include fully integrated capabilities for IDMP (Identification of Medicinal Products), positioning companies to meet this evolving global regulatory standard. • Improved Business Outcomes: The shift to a unified system provides organizations with the necessary insight to improve visibility, accelerate regulatory timelines, and strengthen their overall compliance posture.

Tools/Resources Mentioned:

• Veeva Vault RIM Suite
• Vault Registrations
• Vault Submissions
• Vault Submissions Publishing
• Vault Submissions Archive

Key Concepts:

• Regulatory Information Management (RIM): The systematic management of all regulatory data, documents, and processes required to bring and keep pharmaceutical products on the market globally.
• IDMP (Identification of Medicinal Products): A set of five ISO standards defining the internationally agreed-upon data elements and structures for the unique identification of medicinal products.
• Submission Archiving: The secure, compliant storage and management of completed regulatory dossiers and submission histories, often required for audit trails and long-term regulatory reference.