Labeling - Change Requesting a label

This video provides a practical, step-by-step guide on managing a label change request within Veeva Vault, specifically when a competent authority, such as the EPA, requests modifications to an already submitted label. The core purpose is to demonstrate the workflow for documenting, implementing, and resubmitting these changes while maintaining document integrity and an auditable trail within the Veeva system. The presenter walks through the entire process, from marking the original label as "change requested" to preparing the revised label for resubmission, emphasizing Veeva's functionalities for version control, document renditions, and attachment management.

The demonstration begins with an existing label in a "submitted" state, which the EPA has now requested changes for. The initial step involves updating the status of the original label to "change requested" to accurately reflect its current standing. A critical part of the process is creating a draft of the original document, which ensures that the integrity of the previously submitted version is preserved while allowing for edits on a new, versioned copy (e.g., moving from version 1.0 to 1.1). The video then details the editing process, highlighting the importance of using "track changes" to clearly document all modifications made in response to the authority's request.

Further into the guide, the presenter explains how to leverage Veeva's capabilities for document check-in/check-out, which, in a production environment, integrates seamlessly with Microsoft Word for direct editing. A key feature demonstrated is the "word rendition setting," which allows users to generate both "clean" (no markups) and "shaded" (with track changes visible) versions of the label – both essential for regulatory submissions. The video also covers the "direct release" option for the revised label, contrasting it with a more extensive review workflow. Finally, it illustrates how to attach the EPA's original change request PDF directly to the label within Veeva, linking the request to the specific label version for future reference and auditability, before preparing the final, revised label for resubmission.

Key Takeaways:

• Accurate Status Tracking: It is crucial to mark the original label as "change requested" within Veeva once a competent authority has requested modifications, ensuring the system accurately reflects the document's current regulatory status.
• Preserving Document Integrity with Drafts: Always create a new draft of a submitted document (e.g., version 1.1 from 1.0) when changes are required. This preserves the integrity of the previously submitted version while allowing for documented edits on the new draft.
• Leveraging Veeva's Versioning: Veeva automatically manages document versioning (e.g., 1.0 to 1.1), providing a clear audit trail and the ability to revert to previous steady states if needed. This system-level versioning can potentially reduce the reliance on manual date stamping within the document itself.
• Documenting Changes with Track Changes: Utilize the "track changes" feature during the editing process to clearly highlight all modifications made to the label. This is vital for transparency and regulatory compliance, as authorities often require visibility into all changes.
• Seamless Editing in Production: In a full production environment, Veeva integrates directly with Microsoft Word, allowing for in-system editing without the need to download and re-upload documents, streamlining the check-out/check-in process.
• Generating Clean and Shaded Renditions: Veeva's "word rendition setting" is a powerful feature that allows users to generate both "clean" (final) and "shaded" (with track changes) versions of the label. Both renditions are typically required for submission back to regulatory authorities.
• Automating Rendition Uploads: An upcoming enhancement will automatically upload both clean and shaded versions into the rendition section, further simplifying the preparation of submission packages.
• Workflow Flexibility: Veeva offers workflow options such as "direct release" for immediate finalization or a more extensive "editing or review" process, depending on internal company policies and the nature of the changes.
• Attaching External Regulatory Correspondence: It is a best practice to attach the competent authority's change request (e.g., EPA's PDF) directly to the corresponding label version within Veeva. This links the request to the specific document, providing context and an auditable record for future inquiries.
• Clear Naming Conventions for Submissions: When preparing for resubmission, it is recommended to include the regulatory action in the document title (e.g., "r0102 - EPA Change Request") to easily identify and search for specific documents, especially when managing multiple versions.
• Tracking Document States: Veeva clearly indicates the state of a document (e.g., Draft, Steady State, Submitted, Plan), providing a comprehensive overview of its lifecycle and readiness for various actions.
• Regulatory Compliance Focus: The entire workflow demonstrated is designed to ensure that label changes are managed in a compliant manner, providing the necessary documentation and traceability required by regulatory bodies like the EPA.

Tools/Resources Mentioned:

• Veeva Vault: The primary platform used for managing the label change request process.
• Microsoft Word: The document editor used for making changes to the label, with seamless integration in Veeva's production environment.

Key Concepts:

• Change Request: A formal request from a regulatory authority (e.g., EPA) to modify an already submitted document, such as a product label.
• Competent Authority: The regulatory body responsible for overseeing and approving product labels and other submissions (e.g., EPA in the U.S.).
• Labeling: The process and content of product labels, which are subject to strict regulatory guidelines in industries like pharmaceuticals and life sciences.
• Versioning: The system of tracking and managing different iterations of a document, typically denoted by numbers (e.g., 1.0, 1.1, 2.0), ensuring a historical record of all changes.
• Draft State: A document status indicating that it is under active revision and not yet finalized or in a "steady state."
• Steady State: A document status indicating that it is a finalized, approved, and stable version, often representing a submitted or released document.
• Word Rendition Setting: A Veeva feature that allows the generation of different visual representations of a Word document, specifically "clean" (final version without markups) and "shaded" (version with track changes visible).
• Direct Release: A workflow option in Veeva that allows a document to be immediately finalized and released without requiring additional review steps.
• Regulatory Action: The specific type of submission or interaction with a regulatory authority (e.g., initial submission, change request, amendment).

Examples/Case Studies:

• Natalie's Wonder Product: A fictional product used as an example for the label change process, including an alternate brand name "Natalie's Wonder Product 2.0."
• EPA (Environmental Protection Agency): Cited as the "competent authority" requesting changes to the label, illustrating a real-world regulatory body interaction.