CHAMP/Veeva Integration - Phase II

This video provides an in-depth exploration of the Phase II enhancements to the CHAMP and Veeva integration, focusing on streamlining regulatory submission and approval processes within the pharmaceutical and life sciences sectors. The presentation guides users through a series of updates designed to improve efficiency, data accuracy, and user experience across multiple systems, including CHAMP, Microsoft Dynamics 365 (D365), and Veeva. The core objective of these enhancements is to create a more seamless workflow for managing regulatory activities, from initial task assignment and data input to tracking delays and final approval, ensuring that information is consistently updated and accessible across relevant platforms.

The integration introduces several key features that automate calculations, reduce manual data entry, and enhance communication. Users are shown how to navigate assigned CHAMP tasks, which are now more easily accessible via standardized email notifications with direct hyperlinks. The process begins in D365, where users complete initial regulatory details such as estimated submission and approval dates, triggering the automatic creation of corresponding regulatory actions in Veeva. The system also automatically calculates authority timelines and total duration based on the entered information, simplifying the regulatory planning process.

A significant focus of Phase II is the improved data synchronization and workflow management between D365 and Veeva. Once initial tasks are completed in D365, users are automatically provided with a link to the regulatory action in Veeva, facilitating a smooth transition between systems. In Veeva, new features like the "Responsible Person" field enhance project management capabilities by tracking ownership of registrations and enabling better notification and workflow initiation. Crucially, the introduction of a "CHAMP Delay Tab" allows users to proactively record and communicate delays in submissions or approvals, with this information automatically porting back to D365 to keep all stakeholders, particularly the "mock team," informed and their systems up to date. The video concludes by demonstrating the full lifecycle, from submission to final approval, highlighting how all critical information, including production sites and decision numbers, is seamlessly transferred between Veeva and D365, eliminating duplicative efforts.

Key Takeaways:

• Enhanced Email Notifications and Direct Access: Users now receive standardized email notifications for assigned CHAMP tasks, featuring direct hyperlinks that take them straight to the relevant task in the system, significantly improving accessibility and reducing navigation time.
• Seamless System Integration: The integration establishes a direct connection and seamless workflow between CHAMP (a regulatory change management system), D365 (Microsoft Dynamics 365), and Veeva, allowing for efficient hand-offs and data flow between these critical platforms.
• Automated Regulatory Timeline Calculations: The system automatically calculates the authority timeline and total duration for regulatory actions based on initial submission and approval dates entered in D365, streamlining planning and reducing manual calculation errors.
• Streamlined Data Entry in D365: Unnecessary tabs and fields have been removed from D365, providing users with a more direct and focused interface for completing essential regulatory information, thereby improving efficiency.
• Automatic Regulatory Action Creation in Veeva: Upon completing initial regulatory details in D365, a corresponding regulatory action is automatically created in Veeva, ensuring consistency and initiating the next phase of the workflow without manual intervention.
• Improved Project Management in Veeva: A new "Responsible Person" field in Veeva helps track ownership of each registration, facilitating better notification management, workflow initiation, and overall project oversight for regulatory actions.
• Proactive Delay Tracking with "CHAMP Delay Tab": The introduction of a dedicated "CHAMP Delay Tab" in Veeva allows users to record and manage delays in regulatory submissions or approvals, providing reasons and new expected dates, which are then automatically communicated back to D365.
• Real-time Data Synchronization: Critical information, including submission and approval dates, production sites, and delay reasons, is automatically ported between Veeva and D365/CHAMP, ensuring all systems are up-to-date with the latest regulatory status.
• Consolidated Workflow for Regulatory Lifecycle: The integration supports the entire regulatory lifecycle, from initial task assignment and data input in D365 to submission tracking, delay management, and final approval in Veeva, eliminating the need to revisit D365 for a specific CHAMP once the Veeva action is initiated.
• Focus on Regulatory Impact Reporting: The system generates a regulatory impact report for each country and product, aiding in compliance and strategic decision-making by providing a clear overview of regulatory requirements.
• Option for Document Porting: Users retain the ability to add requested documents to a list in D365, which can then be ported over to Veeva, maintaining a comprehensive record of supporting documentation.
• Enhanced User Experience: The overall integration aims to improve user experience through direct links, reduced duplicative efforts, automated processes, and a clearer, more intuitive workflow for managing complex regulatory tasks.

Tools/Resources Mentioned:

• Veeva (specifically for managing regulatory actions and as a project management tool)
• CHAMP (a system for managing regulatory changes and tasks)
• D365 (Microsoft Dynamics 365, used for initial data entry and broader enterprise operations)

Key Concepts:

• CHAMP/Veeva Integration: The process of linking a regulatory change management system (CHAMP) with Veeva to create a unified and streamlined workflow for regulatory affairs.
• Regulatory Action: A specific event or task within the regulatory process, such as a submission to a health authority or the receipt of an approval.
• Regulatory Impact Report: A document or system output that details the regulatory implications of a specific change or product, often country-specific.
• CHAMP Delay Tab: A new feature within Veeva designed to track and communicate any delays in regulatory submissions or approvals, including reasons and revised timelines.
• Responsible Person: A designated individual assigned ownership of a regulatory registration or action within Veeva, facilitating accountability and workflow management.