Webinar Preview: Streamline Change Control and Variation Management:

This webinar preview outlines a critical challenge for large biopharma organizations: managing the complex, multi-step process of change control and variation management. These companies often execute tens of thousands of changes annually, many of which carry significant downstream regulatory impact. The core problem addressed is the reliance on manual processes to manage these touchpoints, which leads to fragmented information, massive distribution delays, issues with regulatory compliance, and ultimately, increased operational risk. The solution proposed by Veeva Systems is the unification of discrete business processes by connecting Quality and Regulatory systems through an integrated platform.

The central theme of the presentation, featuring Mike Jovanis (VP of Vault Quality) and Marc Gabriel (Sr. Director of Vault RIM), is demonstrating how a unified Quality and Regulatory solution automates information exchange across business functions. This integration is designed to streamline the evaluation of changes to approved products, ensuring that regulatory impact is assessed efficiently and accurately. By moving away from siloed, manual management, organizations can achieve greater transparency throughout the change lifecycle, which is crucial for effective decision-making and risk mitigation.

The key benefits highlighted revolve around measurable improvements in operational performance and compliance posture. Specifically, attendees are promised insights into how to reduce the cycle time required for changes, significantly increase overall efficiency, and reduce regulatory risk by leveraging better intelligence regarding the regulatory impact of each change. The session includes a demonstration of the integrated change control and variation management functionality within the Veeva Vault platform, illustrating how automation and centralized data management can transform what is traditionally a complex and high-risk process into a streamlined, compliant workflow.

Key Takeaways: • High Volume of Changes: Large biopharma organizations routinely handle tens of thousands of changes yearly, many of which necessitate careful evaluation due to their potential regulatory consequences on approved products. • Inefficiencies of Manual Processes: Managing change control through manual methods results in critical failures, including incomplete information transfer, substantial delays in distribution and implementation, and severe risks to regulatory compliance. • Value of Unification: The primary strategy for improvement is unifying traditionally discreet business processes, specifically connecting Quality Management Systems (QMS) with Regulatory Information Management (RIM) systems. • Automation for Compliance: A unified Quality and Regulatory solution automates the necessary information exchange between these critical business functions, ensuring that regulatory teams are immediately aware of quality changes and vice versa. • Improved Decision Making and Risk Reduction: Streamlining change control processes directly improves the quality of decision-making by providing comprehensive, real-time data, thereby lowering the overall regulatory and operational risks associated with product changes. • Cycle Time Reduction: Implementing an integrated system is shown to reduce the cycle time required to execute and approve changes, leading to faster operational agility and quicker implementation of necessary product updates. • Enhanced Regulatory Intelligence: The integration provides "better intelligence around regulatory impact," allowing organizations to accurately assess and predict the regulatory consequences of a proposed change before implementation, ensuring proactive compliance. • Veeva Vault Integration: The solution leverages specific modules within the Veeva ecosystem, namely Vault Quality and Vault RIM, to provide a seamless, integrated platform for managing the entire change control and variation lifecycle.

Tools/Resources Mentioned:

• Veeva Vault Quality: A component of the Veeva Vault suite designed to manage quality processes, including documentation, training, and change control within a regulated environment.
• Veeva Vault RIM (Regulatory Information Management): A component of the Veeva Vault suite focused on managing regulatory submissions, registrations, and variations globally.
• Integrated Change Control and Variation Management: The specific integrated functionality demonstrated in the webinar, which bridges the gap between Quality and Regulatory functions.

Key Concepts:

• Change Control: A formal, systematic process used to manage all changes made to a system, product, or process within a regulated environment (like biopharma) to ensure that quality and compliance are maintained.
• Variation Management: The process of managing regulatory submissions and updates required when changes (variations) are made to approved medicinal products, ensuring compliance with global health authority requirements (FDA, EMA, etc.).
• Unifying Quality and Regulatory Systems: The strategic integration of QMS and RIM platforms to ensure that changes initiated in the quality domain are automatically assessed for regulatory impact, eliminating manual handoffs and data fragmentation.