Quality and Manufacturing Highlights: 2019 Veeva R&D Summit

This video provides an in-depth exploration of quality and manufacturing highlights from the 2019 Veeva R&D Summit, focusing on the transformative projects undertaken by pharmaceutical and life sciences companies. Mike Jovanis, VP of Vault Quality at Veeva, and Kent Malmros, Senior Director of Vault Training, share key reflections on modernizing and unifying quality management systems and integrating training into this unified approach. The discussion highlights a historical context where early electronic quality projects, driven by the emergence of 21 CFR Part 11 in the late 1990s, led to a fragmented landscape of homegrown applications and manual processes, creating a strong impetus for comprehensive transformation.

The presentation delves into several real-world case studies illustrating these transformative initiatives. Samsung Biologics, a contract manufacturing organization, was featured as a keynote speaker, showcasing their successful implementation of Veeva's suite of quality products to modernize their manufacturing environment. Similarly, BMS and Roche presented on their respective Quality Management System (QMS) transformation projects, both aiming to consolidate multiple legacy QMS applications into a single Veeva Vault QMS. BMS specifically focused on collapsing and harmonizing R&D quality with manufacturing quality, while Roche pursued harmonization and consolidation across various previously separate lines of business within their diagnostics sector. PRA Health Sciences, a Contract Research Organization (CRO), also shared their experience with a unification and harmonization project, integrating both Vault QualityDocs and Vault QMS through a multi-phase initiative to bring disparate solution spaces into a single Vault platform.

Kent Malmros then transitions to the critical role of training within this unified quality framework, emphasizing the goal of avoiding the fragmentation issues that plagued document and quality management systems. The discussion centered on improving GxP and quality training effectiveness through unified training management. Foamix shared their journey, demonstrating how their maturation from using QualityDocs to a unified training system was a natural progression, enabling them to eliminate redundant training applications and integrations. Dicerna further elaborated on achieving efficiency and effectiveness across the end-to-end lifecycle of document creation and subsequent training program development within the same application, seamlessly managing curriculum review, approval, assignment delivery, and progress tracking. Finally, Xeris and Xencor, in a panel discussion, echoed these sentiments, highlighting the strategic advantage of a unified training approach to analyze training effectiveness by combining training outcome data with other quality event data.

Key Takeaways:

• Addressing Fragmented Quality Landscapes: The pharmaceutical industry has historically suffered from an "aging fragmented solution landscape" in quality management, stemming from early electronic implementations driven by 21 CFR Part 11, which necessitates transformative projects to unify and modernize systems.
• Strategic QMS Transformation: Companies like BMS and Roche are undertaking significant QMS transformation initiatives to consolidate multiple legacy applications into a single, unified platform (Veeva Vault QMS), leading to improved efficiency and compliance.
• Harmonization Across Business Functions: Beyond consolidation, harmonization of quality processes across different business units, such as R&D quality with manufacturing quality (BMS) or across various lines of business (Roche), is crucial for operational consistency and regulatory adherence.
• Unified Training Management for GxP: Effective GxP and quality training is a cornerstone of regulatory compliance. Implementing a unified training management system, such as Veeva Vault Training, helps avoid the integration complexities and inefficiencies of disparate training applications.
• End-to-End Training Lifecycle Management: Modern unified training systems enable seamless management of the entire training lifecycle, from document creation and curriculum development to assignment delivery, progress tracking, and review/approval, all within a single application.
• Measuring Training Effectiveness: A key advancement is the ability to combine training outcome data with other quality event data to robustly demonstrate the effectiveness of training programs, moving beyond simple completion tracking to actual impact assessment.
• Benefits for Contract Research Organizations (CROs): CROs like PRA Health Sciences benefit significantly from unifying quality documentation (Vault QualityDocs) and QMS (Vault QMS) into a single platform, streamlining operations and ensuring consistent quality across research phases.
• The Transformative Nature of Modern Quality Projects: Current quality projects are not merely about replacing old systems but about fundamentally transforming how quality is managed, leading to more integrated, efficient, and compliant operations.
• Leveraging Integrated Suites: Adopting a comprehensive suite of quality products, such as those offered by Veeva Vault, allows companies to mature their quality processes naturally, moving from document management to integrated training and QMS, thereby eliminating redundant applications and integrations.
• Proactive Compliance: The shift towards unified systems allows companies to proactively manage compliance challenges rather than reactively remediating them, as was often the case with older, fragmented systems.

Tools/Resources Mentioned:

• Veeva Vault Quality
• Veeva Vault QMS
• Veeva Vault QualityDocs
• Veeva Vault Training

Key Concepts:

• 21 CFR Part 11: Regulations concerning electronic records and electronic signatures for the pharmaceutical industry, which historically drove the initial adoption of electronic quality systems.
• GxP (Good Practices): A collection of quality guidelines and regulations ensuring that products are safe and meet their intended use, encompassing areas like Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP).
• QMS (Quality Management System): A formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives, crucial for regulatory compliance in life sciences.
• Unified Training Management: An integrated approach to managing all aspects of employee training, particularly GxP and quality-related training, within a single system to ensure consistency, efficiency, and compliance.
• Quality Event Data: Data related to quality incidents, deviations, CAPAs (Corrective and Preventive Actions), and other quality-related occurrences, which can be analyzed to identify trends and improve processes.
• Harmonization: The process of making different systems, processes, or standards consistent and compatible across various departments, sites, or lines of business within an organization.

Examples/Case Studies:

• Samsung Biologics (Contract Manufacturing): Implemented Veeva quality products to modernize their manufacturing environment.
• BMS (Biopharmaceutical): Consolidated multiple legacy QMS apps into a single Vault QMS and harmonized R&D quality with manufacturing quality.
• Roche (Pharmaceutical/Diagnostics): Harmonized and consolidated QMS across various different lines of business that were previously separate systems.
• PRA Health Sciences (Contract Research Organization - CRO): Implemented Vault QualityDocs and Vault QMS in a three-phase initiative to unify and modernize their quality solution spaces.
• Foamix (Pharmaceutical): Shared their story of maturing from QualityDocs to a unified training system, eliminating training applications and integrations.
• Dicerna (Biopharmaceutical): Discussed efficiency and effectiveness in managing the end-to-end lifecycle of creating documents and developing training programs within the same application.
• Xeris (Pharmaceutical) & Xencor (Biopharmaceutical): Shared insights on leveraging a unified training approach to combine training outcome data with other quality event data to demonstrate training effectiveness.