Registrations: Creating a "Light" Regulatory Action

This video provides a practical, step-by-step guide on creating a "light" regulatory action within Veeva Vault, specifically tailored for product transfers that do not necessitate extensive supporting documentation. The primary purpose is to streamline the regulatory process for scenarios where the registration manager can trust that minimal additional data or documents are required. The context is set around product transfers, using the example of a transfer from Bayer to Envu, emphasizing the critical data points that still need to be captured, such as the registration certificate, approval date, and any changes to product names, involvements, or registration numbers.

The speaker details the progression of creating such an action, beginning with navigating to the registration section in Veeva Vault, filtering for relevant registrations (e.g., Germany's r421), and conducting an initial audit of existing product data for cleanliness and accuracy. A crucial step involves creating a new regulatory action and specifically selecting "Entity Change Product Transfer," which is vital for linking the action to collaborative platforms like a SharePoint site for bear transfers. The video highlights that for these "light" actions, a dossier or binder structure is often unnecessary, but provisions are made for attaching general documents if needed.

A key aspect of the process involves managing the state of the regulatory action. The speaker demonstrates how the system can be configured to allow direct approval for actions that have already been submitted and approved externally, saving time for registration managers. However, a common pitfall is encountered: the system will prevent moving an action to "submitted" or "approved" without an uploaded registration certificate or confirmation letter. This leads to a detailed explanation of how to add a "received document," including uploading the certificate and populating its metadata (date, country, territory, language, issuing organization, product). Finally, the video covers updating the core registration details, such as product names or registration numbers, and critically, updating the "product involvement" to reflect the company's current role (e.g., registration holder) post-transfer, ensuring all associated contact information is accurate.

Key Takeaways:

• "Light" Regulatory Actions Defined: These are designed for processes like product transfers where the registration manager determines that extensive supporting documents or complex documentation structures (like binders) are not required, streamlining the workflow.
• Essential Data Capture: Even in a "light" process, it is crucial to upload the registration certificate, document the approval date, and meticulously record any changes to product names, product involvements, or registration numbers.
• Opportunity for Data Audit: Product transfer processes, which often involve touching numerous registrations, present an excellent opportunity to audit existing product data in Veeva Vault, ensuring accuracy and completeness.
• Step-by-Step Action Creation: The process begins by navigating to the registration section, filtering for specific registrations, reviewing existing data, and then initiating a new regulatory action.
• Crucial Action Type Selection: When creating the new regulatory action, it is imperative to select "Entity Change Product Transfer." This specific selection is vital for linking the action to external collaborative sites, such as a SharePoint site for transfer data.
• Flexible Document Handling: For "light" actions, a dossier or binder structure is typically not needed. However, if additional documents are required, users can select "General documents without binder" to attach them directly.
• Streamlined Approval Workflow: Veeva Vault can be configured to allow regulatory actions for specific processes to be pushed directly to an "approved" state, bypassing the "submitted" status, which significantly saves time for registration managers when actions have already been approved externally.
• Mandatory Document Upload for Approval: A critical system validation prevents moving a regulatory action to "submitted" or "approved" without first uploading the official registration certificate or confirmation letter as a "received document."
• Detailed Received Document Process: To overcome the approval block, users must navigate to the "received document" section, upload the registration certificate, and accurately fill in its metadata, including date, country, territory, language, issuing organization, product, and ensuring the regulatory action is automatically linked.
• Updating Registration Details: Post-approval, it is essential to return to the main registration section to update any changes to the registration number or product name resulting from the transfer.
• Managing Product Involvement: A new "product involvement" object must be created or updated to reflect the company's current role with the product (e.g., registration holder, distributor). This includes associating the correct company and contact information.
• Contact for Missing Data: If any necessary data points (e.g., company names for product involvement) are missing in the system, users are advised to contact the Veeva team for assistance in adding them.

Tools/Resources Mentioned:

• Veeva Vault: The primary platform for managing registrations and regulatory actions.
• SharePoint: Mentioned as a collaborative site for linking transfer data.

Key Concepts:

• Light Regulatory Action: A simplified regulatory action process in Veeva Vault for transfers or changes with minimal documentation requirements.
• Regulatory Action: A formal process recorded in Veeva Vault to document changes, approvals, or transfers related to product registrations.
• Registration Certificate: The official document confirming product registration and approval, mandatory for moving regulatory actions to an approved state.
• Product Involvement: Defines the company's role or relationship with a specific product (e.g., registration holder, distributor).
• Entity Change Product Transfer: A specific type of regulatory action in Veeva Vault used to document the transfer of product ownership or responsibility between entities.