Danielle Pund | Increasing Clinical Adoption of Vault QMS - Register for Veeva Summit on October 14

This video provides an overview and invitation to a specialized roundtable session at the upcoming Veeva R&D and Quality Summit, focusing on the strategic expansion of Veeva Vault Quality Management System (QMS) adoption within clinical operations. The speaker, Danielle Pund, Director of Strategy for the Vault Quality Suite at Veeva, highlights the growing industry imperative to maximize QMS investment by successfully integrating clinical stakeholders and processes into the quality platform. The session is specifically designed to address the challenges and opportunities associated with extending the Quality Suite's functionality to cover Good Clinical Practice (GCP) requirements.

The core objective of the roundtable, "Increasing Clinical Adoption of Vault QMS," is to facilitate knowledge sharing among industry leaders regarding the convergence of quality processes and clinical trials. As pharmaceutical and biotech companies increasingly seek unified platforms for GxP compliance, the traditional separation between manufacturing/lab quality and clinical quality events (such as deviations, CAPAs, and audits related to trials) is dissolving. The session aims to discuss practical use cases and established best practices for managing clinical quality events directly within Vault QMS, ensuring end-to-end quality oversight from product development through clinical testing.

The format is intended to be highly interactive, bringing together customers who have already successfully implemented QMS for GCP compliance alongside those who are exploring this expansion. This peer-to-peer engagement is crucial for increasing the comfort level of clinical stakeholders—who may traditionally use separate systems—with adopting a centralized quality platform. By sharing successful methodologies, the session seeks to break down organizational silos between Quality Assurance and Clinical Operations departments, leading to more efficient processes, streamlined audit trails, and enhanced regulatory adherence across the entire product lifecycle.

For specialized consulting firms focused on regulated enterprise software and AI integration, this topic signals a critical area of client need. The push toward unified QMS adoption in clinical settings creates demand for services that can manage complex system integrations (e.g., connecting QMS data with Clinical Trial Management Systems or eTMFs), develop custom workflows, and deploy AI solutions to automate compliance tracking and reporting for clinical quality events. The focus on maximizing investment underscores the need for strategic consulting to ensure technology adoption translates into tangible operational efficiencies and improved regulatory posture under GCP guidelines.

Key Takeaways: • GCP Integration is a Strategic Priority: The industry is actively moving to expand the use of the Vault Quality Suite to cover Good Clinical Practice (GCP), indicating a strategic shift toward unifying quality management across R&D and clinical operations rather than limiting it to manufacturing quality (GMP). • Maximizing QMS ROI Requires Clinical Buy-in: To fully realize the return on investment for Vault QMS, organizations must successfully engage and integrate clinical stakeholders, necessitating tailored use cases and change management strategies specific to clinical trial processes. • Focus on Clinical Quality Events: The primary application of QMS expansion into the clinical domain involves managing quality events such as clinical deviations, CAPAs originating from clinical audits, and ensuring robust documentation compliant with GCP standards. • Knowledge Sharing for Comfort Level: The roundtable format emphasizes peer-to-peer knowledge exchange, which is vital for reducing resistance and increasing the comfort level among clinical staff regarding the adoption of a centralized QMS platform for their specific compliance needs. • Addressing Organizational Silos: Successful clinical adoption of QMS requires breaking down traditional functional silos between Quality Assurance (QA) and Clinical Operations, enabling a more cohesive and compliant approach to quality management across the enterprise. • Demand for Integrated GxP Solutions: The trend highlights the growing demand among life sciences companies for a single, validated system capable of handling multiple GxP requirements (GCP, GMP, GLP), simplifying audit readiness and regulatory reporting. • Consulting Opportunity in Workflow Customization: The need for "best practices" and "use cases" suggests that organizations require specialized consulting to customize Vault QMS workflows and configurations to accurately reflect complex clinical trial protocols and regulatory requirements. • Need for Change Management: Implementing QMS in clinical settings is not just a technology deployment; it requires significant organizational change management and training to ensure clinical teams understand how to use the system effectively for managing their specific quality processes. • Veeva Summit as a Key Intelligence Source: The Veeva R&D and Quality Summit is identified as a critical venue for gathering intelligence on platform roadmaps, industry adoption trends, and regulatory interpretations related to the Veeva Vault ecosystem.

Tools/Resources Mentioned:

• Veeva Vault QMS (Quality Management System)
• Veeva R&D and Quality Summit
• Veeva Vault Quality Suite

Key Concepts:

• Vault QMS: A cloud-based quality management system offered by Veeva Systems, used by life sciences companies to manage quality processes like deviations, CAPAs, change control, and audits.
• GCP (Good Clinical Practice): International ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
• Clinical Adoption: The process of successfully integrating and utilizing a software platform (like Vault QMS) within the Clinical Operations department, ensuring that clinical staff use the system for their daily quality and compliance tasks.