Veeva Vault RIM Submission Archiving Overview : How Vault Submission Archive Works

This video provides an in-depth exploration of Veeva Vault RIM's Submission Archiving features, detailing how regulatory professionals can effectively manage and access published regulatory submissions. The speaker, an expert in Veeva systems, outlines the core functionalities of the Submission Archive, emphasizing its role as a global repository for documents submitted to health authorities worldwide. The presentation begins by establishing the context of submission archiving within the broader Veeva RIM suite, building upon previous discussions of submission publishing and regulatory registrations.

The core of the discussion revolves around the capabilities of Veeva Vault RIM Submission Archive, which is designed to import, archive, and facilitate the viewing of published submissions in a structured manner. This includes support for both eCTD (electronic Common Technical Document) and non-eCTD formats, ensuring comprehensive coverage for various regulatory requirements. The speaker highlights how the system provides a secure and globally accessible platform for regulatory users to review published outputs that were sent to health authorities, complete with dynamic access controls to ensure data security and compliance. An integrated eCTD viewer is presented as a key feature, allowing for quick review of content across applications and submissions, and providing contextual information on how content was reused across different regulatory filings.

Further detailing the system's utility, the video delves into specific features such as purpose-built import and export functionalities, the integrated eCTD submission viewer, and PDF link navigation. The import function allows for the ingestion of dossier data in both eCTD and non-eCTD formats, while the export feature enables users to extract dossier data with the same structured folder hierarchy, facilitating reuse for other regions or purposes. The integrated viewer provides a structured display of published documents, often converted to PDF, with navigable links for seamless review of content, metadata, and historical changes. Additionally, the video introduces the built-in dashboard and reporting capabilities, specifically mentioning the "Application Chronology" report, which offers a consolidated view of submissions, regulatory objectives, commitments, and correspondence documents, enhancing oversight and strategic planning for regulatory teams. The session concludes by briefly touching upon the concept of "archive correspondence," which includes critical communication documents like approval letters and meeting minutes exchanged with health authorities.

Key Takeaways:

• Centralized Regulatory Submission Repository: Veeva Vault RIM Submission Archive serves as a global, secure hub for importing, archiving, and viewing all published regulatory submissions sent to health authorities, supporting both eCTD and non-eCTD formats.
• Structured Access to Published Outputs: The system ensures that published outputs are viewable in a proper, structured way, allowing regulatory users to easily access and review documents that have already been submitted.
• Dynamic Access Control and Security: Robust security features, including dynamic access control, are integrated to ensure that only authorized users can view specific published documents, maintaining data integrity and regulatory compliance.
• Integrated eCTD Viewer for Comprehensive Review: An integrated eCTD viewer allows for quick and efficient review of content across various applications and submissions, providing insights into content reuse and submission context.
• Purpose-Built Import and Export Functionality: The system offers dedicated features for importing dossier data (eCTD and non-eCTD) and exporting it while maintaining the original folder structure, which is crucial for leveraging submissions across different regions.
• PDF Link Navigation for Enhanced Usability: Published documents are often converted to PDF format with generated links, enabling users to easily navigate between related documents, review metadata, and track content history.
• Built-in Reporting and Dashboards: Veeva Vault RIM includes powerful reporting capabilities, such as the "Application Chronology" report, which provides a consolidated view of submissions, regulatory objectives, commitments, and correspondence for better oversight.
• Management of Archive Correspondence: The system archives critical communication documents, referred to as "archive correspondence," which includes approval letters, meeting minutes, telephone contacts, and email acknowledgements from health authority interactions.
• Facilitates Global Accessibility: Submissions and their published outputs are accessible by authorized users anywhere across the globe, streamlining international regulatory operations and collaboration.
• Supports Regulatory Compliance: By providing a structured, secure, and auditable archive of regulatory submissions and communications, the system significantly aids in maintaining regulatory compliance with bodies like the FDA and EMA.

Tools/Resources Mentioned:

• Veeva Vault RIM (Regulatory Information Management)
• Veeva Vault Submission Archive
• eCTD Viewer

Key Concepts:

• Submission Archiving: The process of securely storing and managing published regulatory submissions and their associated documents after they have been sent to health authorities.
• eCTD (electronic Common Technical Document): A standard format for electronically submitting applications, amendments, supplements, and reports to regulatory authorities, particularly in the pharmaceutical industry.
• Archive Correspondence: Communication documents exchanged with health authorities during the submission process, such as approval letters, meeting minutes, telephone contacts, and acknowledgement emails, which are stored for historical record and compliance.
• Application Chronology Report: A built-in report within Veeva Vault RIM that provides a chronological overview of an application's regulatory activities, including submissions, regulatory objectives, commitments, and correspondence.