Veeva Vault RIM Overview : Submission Key Features.

This video provides an in-depth exploration of Veeva Vault RIM (Regulatory Information Management), specifically focusing on its submission key features. The speaker, presenting on "Day 2" of a series following a discussion on the RIM data model, aims to deliver valuable insights to professionals working with Veeva applications. The core objective is to demystify the submission process within Veeva Vault RIM, highlighting how its functionalities streamline regulatory content management from authoring to approval and assembly.

The presentation begins by outlining the fundamental structure of the Veeva Vault RIM application, which is characterized by two primary components: 'Submission' and 'Regulatory Objective.' The speaker clarifies that a regulatory objective represents a goal that must be achieved by submitting content to a health authority, with the submission itself being the mechanism to fulfill this objective. The discussion then transitions into the core features designed for efficient management of regulatory content, including content management, submission templates, a customizable data model, and robust review workflows. A significant portion of the explanation is dedicated to the eCTD (Electronic Common Technical Document) format, which is the standard followed by regulatory bodies like the FDA, detailing its five-module structure and the unique purpose of each module, such as Module 3 for quality documents and Module 5 for clinical study reports.

Further into the video, the speaker elaborates on specific key features that enhance the submission process. These include predefined document types (e.g., clinical, non-clinical, quality, regulatory, pharmacovigilance) that align with submission requirements, and a comprehensive lifecycle and workflow system that guides submissions through various states like "planning," "send for health authority," and "authority received." A notable improvement highlighted is the content planning feature, which allows users to create detailed lists of documents for submission directly within Veeva Vault RIM, replacing traditional spreadsheet-based methods. The video also touches upon the "report level content plan" for publishing content outside of a main submission and the "publishing status indicator," a visual cue (green sign) that confirms a content plan is ready for publication after backend validation. The speaker emphasizes how these integrated features contribute to a seamless and compliant experience for regulatory professionals.

Key Takeaways:

• Veeva Vault RIM Structure: The application is fundamentally built around two interconnected components: 'Submission' and 'Regulatory Objective.' A submission is the means by which a regulatory objective (a goal to be achieved with a health authority) is fulfilled.
• End-to-End Submission Management: Veeva Vault RIM is designed as an end-to-end application for the efficient management of regulatory content, encompassing authoring, review, approval, and assembly of various submission types.
• Core Submission Features: Key functionalities include robust content management with pre-configured document types, submission templates adhering to industry standards, a customizable data model, and tailored review workflows to ensure compliance.
• eCTD Format Adherence: The system supports the eCTD (Electronic Common Technical Document) format, which is a recommended structure for regulatory submissions, particularly for health authorities like the FDA.
• eCTD Module Breakdown: The eCTD structure comprises five distinct modules, each serving a unique purpose; for example, Module 3 is dedicated to quality documents, Module 4 to non-clinical study reports, and Module 5 to clinical study reports.
• Pre-configured Document Types: Veeva Vault RIM offers default document types, subtypes, and classifications (e.g., clinical, non-clinical, quality, regulatory, pharmacovigilance) that are pre-aligned with common regulatory submission requirements, simplifying content organization.
• Lifecycle and Workflow Management: Submissions are guided through defined lifecycle states and workflows (e.g., "planning," "send for health authority," "authority received") to ensure proper progression, tracking, and adherence to regulatory processes.
• Streamlined Content Planning: The platform includes a dedicated content planning feature that allows users to quickly create and manage lists of all documents expected for a submission, effectively replacing manual spreadsheet-based planning and ensuring alignment with eCTD format.
• Report Level Content Plans: Beyond main submissions, Veeva Vault RIM supports "report level content plans," enabling the publishing of specific content or reports independently, catering to diverse regulatory needs.
• Publishing Status Indicator: A crucial feature for publishers is the "publishing status indicator," which provides a clear visual confirmation (e.g., a green sign) that a content plan and its associated documents have successfully completed backend validation and are ready for publication or import.
• Tailored Processes for Compliance: The customizable data model and review workflows allow organizations to tailor processes to their specific needs, ensuring compliance with regulatory standards and internal operational requirements.
• Seamless User Experience: The integrated nature of these features within Veeva Vault RIM aims to provide a seamless experience for regulatory professionals, enhancing efficiency and reducing the complexity of managing submissions.

Tools/Resources Mentioned:

• Veeva Vault RIM
• eCTD (Electronic Common Technical Document) format

Key Concepts:

• Regulatory Information Management (RIM): A system designed to manage all regulatory data, documents, and processes throughout the lifecycle of a product.
• Submission: The package of documents and data sent to a health authority for regulatory approval or other regulatory actions.
• Regulatory Objective: A specific goal or requirement that needs to be achieved through a regulatory submission.
• eCTD (Electronic Common Technical Document): An internationally agreed-upon standard for organizing regulatory submissions electronically, consisting of five modules.
• Content Plan: A structured list of all documents and information required for a regulatory submission, often organized according to the eCTD format.
• Document Type: Predefined categories for documents within Veeva Vault RIM (e.g., clinical, non-clinical, quality) that help in organizing and classifying content for submissions.
• Lifecycle and Workflow: The sequence of states and automated actions that a submission or document progresses through from creation to final approval and archiving, ensuring compliance and process adherence.