Transform Change Management with a Modern QMS

This video provides an in-depth exploration of transforming change management within the life sciences industry through the adoption of a modern Quality Management System (QMS). Presented by Veeva Systems, the webinar highlights the critical challenges faced by pharmaceutical and biotech companies, such as the overwhelming volume and complexity of changes, particularly post-marketing approval. Speakers Robert Getna and Timur Sojustak detail how traditional, siloed, and document-centric approaches hinder innovation and efficiency, leading to significant backlogs, unpredictable lead times, and a high risk of non-compliance.

The core of the presentation focuses on Veeva's solution, Vault Quality, which aims to revolutionize change management by fostering cross-functional and global collaboration on a unified, cloud-based platform. This approach emphasizes a fundamental shift from handling documents to managing structured data, and subsequently, leveraging this data for actionable intelligence. The speakers illustrate how an integrated system can provide real-time insights across quality, regulatory, and other critical functions, enabling seamless information exchange and proactive decision-making. The discussion extends to the importance of harmonizing regulatory approaches, citing initiatives like ICH Q12, and the necessity of engaging external partners like Contract Manufacturing Organizations (CMOs) in a more integrated manner.

A significant portion of the webinar is dedicated to a live demonstration of Veeva Vault Quality, showcasing its capabilities for impact and risk assessment. The demo illustrates the use of dynamic, context-aware checklists that guide users through the assessment process, automatically identifying regulatory impacts and linking to related regulatory events within Veeva Vault RIM. This integration allows for automated impact assessments on affected markets and registrations, streamlining a traditionally complex and manual process. The presentation concludes by emphasizing the value of data-driven dashboards for gaining a high-level overview of change control status, identifying risks, and analyzing trends across multiple changes, thereby enhancing overall organizational understanding and control.

Key Takeaways:

• Magnitude of Change Management Challenges: Life science companies face immense pressure with over 200 changes per product annually, potentially leading to 40,000 change requests per year for top pharma companies. Implementation rates are often below 50%, resulting in long lead times and significant backlogs.
• Criticality of Post-Approval Changes: Changes occurring after marketing approval are highly formalized and complex, often taking months or even years to implement. This bottleneck significantly hinders continuous improvement and innovation, as highlighted by nearly 100% of survey participants in 2017 stating their current processes impede progress.
• Limitations of Existing Solutions: Traditional QMS implementations are often point solutions with siloed functions, leading to disconnects between quality and regulatory processes. A significant portion (83%) of companies still rely on hybrid data collection, mixing structured data with unstructured, paper-centric documents, which prevents effective data analysis and real-time insights.
• Three Pillars of Transformation: A modern approach to change management requires three fundamental shifts: moving from siloed, local processes to cross-functional and global collaboration; transitioning from document handling to structured data handling; and leveraging data to generate actionable intelligence.
• Unified Platform for End-to-End Processes: Implementing a unified, cloud-based platform (like Veeva Vault Quality and Vault RIM) is crucial for managing end-to-end change and variation processes. This platform enables real-time insights, seamless information exchange between quality, regulatory, and other stakeholders, and supports external collaboration with CMOs and suppliers.
• Data as the Master Record: The concept of transforming documents into structured data, especially for content like specifications, is vital. This allows for granular assessment and tracking of changes, building intelligence into processes (e.g., dynamic checklists), and ensuring data integrity across the product lifecycle, rather than relying on static document representations.
• Smart and Dynamic Checklists: Electronic checklists can be configured to be dynamic and context-aware, guiding users through impact and risk assessments. These checklists can leverage regulatory guidance, best practices, and historical data to define criticality, identify stakeholders, propose actions, and even trigger subsequent process steps based on responses.
• Integrated Quality System Benefits: A fully integrated quality system connects change management to other quality processes (e.g., deviations, CAPAs) and links changes to their targets (products, organizations, equipment, documents). This connectivity provides comprehensive visibility and the ability to generate protocols and impact assessments on demand.
• Automated Regulatory Impact Assessment: Modern QMS solutions, when integrated with regulatory information management (RIM) systems, can automatically assess the impact of changes on registered products, markets, and submissions. This significantly reduces manual effort and ensures comprehensive regulatory compliance.
• Data-Driven Dashboards for Insights: Aggregating data from various change controls into reports and dashboards provides a high-level overview of current activities, identifies past-due changes, analyzes impacted areas (commercial, manufacturing), and visualizes assessment data (e.g., product impact, quality impact severity).
• External Partner Collaboration: While systems enable deep collaboration with external partners, the level of information disclosure and integration depends on an organization's maturity and specific policies. Proactive sharing of change planning and assigning actions within the system can significantly improve predictability and compliance.
• Inspector Acceptance of Digital Records: Shifting from document-centric to data-centric records requires proving compliance with regulations like 21 CFR Part 11 and EU GMP Annex 11. Education and clear demonstration of controls, audit trails, and electronic signatures are key to gaining acceptance from regulatory inspectors.

Tools/Resources Mentioned:

• Veeva Vault Quality: A modern QMS system designed for the life sciences industry.
• Veeva Vault RIM (Regulatory Information Management): A system for managing end-to-end regulatory processes, including submissions and registrations, integrated with Vault Quality.
• ON24: The webinar platform used for the presentation.

Key Concepts:

• Change Management: The systematic process of managing changes to a product, process, or system within an organization, particularly critical in regulated industries like life sciences.
• QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
• Post-Approval Changes: Modifications made to a drug product, manufacturing process, or quality system after initial marketing approval, which require formal assessment and regulatory notification/approval.
• Regulatory Variations: Changes to a product's marketing authorization that must be submitted to regulatory authorities (e.g., FDA, EMA).
• ICH Q10/Q12: International Council for Harmonisation (ICH) guidelines related to Pharmaceutical Quality System (Q10) and Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (Q12), emphasizing a harmonized approach to change management across the product lifecycle.
• GxP (Good x Practice): A collection of quality guidelines and regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) that ensure products are safe and meet quality standards.
• 21 CFR Part 11: Regulations issued by the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
• EU GMP Annex 11: European Union guidelines on computerized systems used in pharmaceutical manufacturing, ensuring data integrity and system validation.
• Product Lifecycle Management (PLM): The process of managing the entire lifecycle of a product from its conception, through design and manufacture, to service and disposal, including all associated data and information.
• Document-centric vs. Data-centric: A shift from relying primarily on static documents for information storage and process execution to utilizing structured data that can be dynamically analyzed, linked, and leveraged for intelligence.
• Smart Checklists: Dynamic, electronic checklists that adapt based on user input, context, and predefined rules, providing guided assessments and automating subsequent process steps.

Examples/Case Studies:

• New Manufacturer for a Product (Voltovio Salt): The live demonstration used a scenario involving a change control for a new manufacturer of a product called "Voltovio Salt." This example illustrated how to perform an impact and risk assessment, run a guided checklist, and assess regulatory impact across different markets.
• Change of a Limit in Specifications: The speakers discussed how a change in a limit for established acceptance criteria in a product specification is more critical than changing an internal reference. This highlights the need for granular data management and dynamic guidance in impact assessment.
• Impact Assessment on Registered Products: The demo showed how Veeva Vault RIM could automatically generate an impact assessment report, listing all affected markets and approved registrations (e.g., US, Germany, France, Malaysia, Belgium) for a regulatory event linked to a change control.