Automating Change Control: Connecting Quality and Regulatory

This video provides an in-depth exploration of automating change control by unifying quality and regulatory processes within a single, connected ecosystem, specifically leveraging Veeva Vault applications. Michael Jovanis, Vice President of Vault Quality at Veeva Systems, details how traditionally disconnected systems and manual communication methods have created inefficiencies and risks in pharmaceutical change management. The core premise is that by integrating Quality Management System (QMS) functionalities with Regulatory Information Management (RIM) and content management, organizations can achieve proactive quality management, streamline operations, and enhance compliance.

Jovanis elaborates on the total chain of events in change management, starting from a quality event, its investigation, root cause analysis, and the assembly of a CAPA (Corrective and Preventive Action) program. These CAPA programs frequently trigger change control, which historically involved numerous disparate systems. He highlights how Veeva Vault's unified environment eliminates these disconnections, allowing for seamless integration. Specifically, during the impact assessment phase of a change control, direct connections can be made with regulatory stakeholders through the Vault Registrations application, enabling automated lookups and reports to determine regulatory impact. This intelligence is then returned to the change control process, informing decision-makers immediately.

Beyond the quality-regulatory connection, the presentation also emphasizes the unification of document change control and training. When QMS and content management reside in the same environment, impacted documents can be identified, grouped, and directly linked to a change, providing transparent status visibility and rationalizing review and approval processes to reduce cycle times. Similarly, the impact on user training, often required due to CAPA programs or new changes, can be seamlessly connected and managed within the unified platform. Jovanis concludes by stressing that while technology provides the necessary connection points and standardized processes, successful implementation requires significant attention to organizational change management and business consulting to break down traditional silos between quality and regulatory departments.

Key Takeaways:

• Unified Change Management Ecosystem: Veeva Vault provides a single, connected platform that integrates QMS, regulatory information management (RIM), content management, and training, eliminating the inefficiencies of previously disconnected applications.
• Streamlined Quality Event to Change Control: The process from a quality event through investigation, root cause analysis, CAPA program, and subsequent change control is unified, ensuring direct triggers and comprehensive management within one system.
• Direct Regulatory Impact Assessment: Change controls with potential regulatory impact can directly message regulatory stakeholders via the Vault Registrations application, facilitating automated lookups and reports to determine the necessary regulatory actions.
• Enhanced Visibility of Regulatory Approvals: Once regulatory activities are complete, the status of country-by-country approvals can be surfaced directly within the quality domain, providing immediate intelligence for product shipment decisions.
• Integrated Document Change Control: By co-locating QMS and content management, impacted documents can be identified, packaged, and linked directly to a change, offering transparent status updates and rationalizing review/approval cycles to reduce overall cycle time.
• Seamless Training Management: The impact of CAPA programs or new changes on user training requirements can be seamlessly linked and managed within the unified system, ensuring that necessary training adjustments are identified and implemented.
• Addressing the Quality-Regulatory Disconnect: The platform directly tackles the "age-old disconnect" between quality and regulatory departments, moving away from manual communication methods like emails and phone calls to a structured, automated business process.
• Technology as an Enabler, Not a Sole Solution: While technology provides the crucial connection points and standardized processes, the success of unifying quality and regulatory processes heavily relies on organizational change management.
• Importance of Business Consulting: Implementing such integrated systems requires a consultative approach to manage the organizational change, tear down departmental barriers, and ensure that teams adapt to new, unified business processes effectively.
• Proactive Quality Management: By connecting these critical functions, organizations can move towards a more proactive quality management approach, making informed decisions with real-time data and intelligence.
• Reduced Duplication and Cycle Times: Unifying processes for document review and approval across quality and content management domains helps eliminate redundant efforts and significantly reduces the overall cycle time for changes.

Tools/Resources Mentioned:

• Veeva Vault QMS
• Veeva Vault Registrations (part of Veeva's RIM suite)

Key Concepts:

• Change Management: The systematic approach to dealing with the transition or transformation of an organization's goals, processes, or technologies. In this context, specifically managing changes to products, processes, or systems in a regulated environment.
• CAPA (Corrective and Preventive Action): A process for investigating and correcting identified nonconformities (corrective action) and preventing their recurrence (preventive action).
• QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• RIM (Regulatory Information Management): Systems and processes used to manage all regulatory information and activities throughout a product's lifecycle, from submission planning to approval and post-market changes.
• Regulatory Impact Assessment: The process of evaluating how a proposed change will affect a product's regulatory status, submissions, or compliance requirements in various markets.
• Business Process Unification: The integration and streamlining of previously separate or disconnected business processes into a single, cohesive workflow.