CHAMP and Veeva - Working Together!

This video provides an in-depth exploration of the integrated workflow between CHAMP (a system for managing regulatory impact reports, likely residing within D365) and Veeva, specifically focusing on streamlining regulatory submissions and approvals. The presenter demonstrates a practical, step-by-step process for pharmaceutical and life sciences professionals, highlighting how these two critical enterprise systems work in concert to eliminate duplicative work and enhance efficiency. The core message revolves around the automated data synchronization and workflow management that occurs when managing regulatory actions, from initial impact assessment to final approval.

The demonstration begins by illustrating how users can initiate a regulatory impact report within CHAMP, either via an email hyperlink or by navigating through the D365 common module. Key initial data points, such as estimated submission and approval dates, country matrix details (internal preparation and authority review times), and required documents, are entered into CHAMP. A pivotal aspect of this integration is the automatic creation of a corresponding regulatory action within Veeva once the initial data is saved in CHAMP, establishing a seamless link between the two platforms. This automation ensures that all subsequent regulatory work is centralized in Veeva, leveraging its robust capabilities for content and process management.

The video then transitions to detailing the work performed within Veeva. It shows how the automatically generated regulatory action in Veeva contains ported data from CHAMP, including reference numbers, comments, and requested documents. The presenter guides viewers through updating specific fields within Veeva, such as the regulatory action type (e.g., "Amendment for production site change"), managing requested documents by linking them to relevant production sites, and attaching necessary submission forms. Furthermore, the process of updating product specifications and production site information within Veeva is covered, emphasizing that this data will also synchronize back to D365. The workflow concludes with advancing the regulatory action through its lifecycle, from "Pending" to "Submitted" and finally to "Approved," demonstrating how approval documents are added and how the final approval dates and production site changes in Veeva automatically update the corresponding records in D365, completing the end-to-end automated process.

Key Takeaways:

• Seamless System Integration: The video demonstrates a powerful integration between CHAMP (within D365) and Veeva, designed to eliminate manual data entry and reduce errors in regulatory processes. This integration is crucial for maintaining data consistency across platforms.
• Streamlined Regulatory Workflow Initiation: Users can easily access assigned CHAMP regulatory impact reports either through direct email hyperlinks or by navigating within D365's 'Common' module, providing flexible access points to initiate regulatory work.
• Automated Regulatory Action Creation in Veeva: Initial data entry in CHAMP, including estimated submission and approval dates, automatically triggers the creation of a corresponding regulatory action in Veeva, ensuring that the regulatory process is immediately captured in the primary compliance system.
• Centralized Regulatory Management in Veeva: Once the initial regulatory impact report is completed in CHAMP, all subsequent detailed work, such as editing action details, managing requested documents, attaching submission forms, and progressing the workflow, is conducted directly within Veeva.
• Comprehensive Data Porting: Critical information like CHAMP reference numbers, action comments, requested documents (e.g., Certificate of Analysis, Declaration of Origin), and expected submission/approval dates are automatically ported from D365 to Veeva, minimizing manual transcription.
• Dynamic Document Management: The system supports attaching submission documents via drag-and-drop functionality and managing requested documents by linking them to specific production sites and adding remarks for the documentation team, enhancing clarity and organization.
• Production Site Management and Synchronization: Users can update and manage production site information within Veeva, which is critical for regulatory submissions. Importantly, any changes to production sites made in Veeva are automatically synchronized back to D365.
• Workflow Progression and Status Updates: The video illustrates how to move regulatory actions through different workflow states (e.g., Pending, Submitted, Approved) by entering specific dates, providing clear tracking of the submission lifecycle.
• Automated Post-Approval Updates: Upon approval of a regulatory action in Veeva, the system automatically updates D365 with the approval date, registration status, and any final production site changes, ensuring that both systems reflect the most current regulatory status without manual intervention.
• Efficiency Gains and Reduced Duplication: The primary benefit highlighted is the elimination of duplicative work, allowing regulatory professionals to focus on content and strategy rather than manual data transfer between systems.
• Future Enhancements: The presenter notes upcoming improvements, such as immediate (rather than overnight) porting of requested documents and the introduction of specific actions for regulatory managers to streamline state changes, indicating continuous system evolution.

Tools/Resources Mentioned:

• CHAMP: A system or module used for managing regulatory impact reports, likely integrated with D365.
• Veeva: Specifically, Veeva Vault, a platform for content and data management in life sciences, used here for regulatory actions and submissions.
• D365: Microsoft Dynamics 365, serving as the platform where CHAMP resides and from which data is initially managed and then synchronized with Veeva.

Key Concepts:

• Regulatory Impact Report: A formal document or process used to assess the potential regulatory implications of a proposed change or new product, typically initiating a series of regulatory actions.
• Regulatory Action: A specific task or set of tasks undertaken to fulfill regulatory requirements, such as preparing a submission, responding to agency queries, or managing post-market changes.
• Data Porting/Synchronization: The automated process of transferring data between two or more distinct software systems, ensuring consistency and reducing manual data entry.
• Workflow Management: The systematic organization and execution of a series of tasks or steps required to complete a process, often involving predefined states and transitions.
• Production Site Management: The process of tracking, updating, and ensuring compliance for manufacturing and packaging sites associated with pharmaceutical products, critical for regulatory submissions and approvals.