Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance

This video, presented by Veeva Systems, provides an in-depth exploration of unifying quality manufacturing processes within the life sciences industry. It begins by establishing the current landscape, where increasing regulations, globalization, externalization of operations, growing product complexity (e.g., biologics, combination products), and frequent mergers and acquisitions create significant challenges. These industry shifts, coupled with the prevalence of paper-based or fragmented legacy quality systems, have created a "perfect storm" that necessitates a move towards agile, digital, and unified quality management solutions. The core message emphasizes how a unified cloud solution, specifically Veeva's Vault Quality Suite, can drive speed, collaboration, and GxP compliance by connecting end-to-end quality management.

The speakers, Ashley Wentworth and Glenda Guzman, delve into key opportunities for unification, focusing on two main areas: connecting quality processes within an organization and improving collaboration with third parties. Internally, this involves consolidating multiple disparate applications for document management, Quality Management Systems (QMS), and compliance-related training onto a single platform. The discussion highlights the benefits of unifying QMS processes and data, moving away from fragmented applications to an intelligent, consolidated approach. A significant focus is placed on streamlining complex processes like change control, which traditionally involves numerous siloed systems and manual handoffs. A unified system can seamlessly link quality events, CAPA processes, document updates, automated retraining, and control the release of changes, collapsing cycle times and increasing accuracy.

The presentation further elaborates on the critical need for improving collaboration with third parties, such as suppliers, partners, and customers. It addresses the historical failures of attempting to connect external users to legacy on-premise systems, which were plagued by complex integrations, security issues, and training burdens. Modern unified cloud applications, however, offer a simple and secure way to extend granular access to specific parts of the quality system, enabling real-time collaboration. Glenda's demonstration of the Veeva Vault Quality Suite (comprising Vault QMS, Vault Quality Docs, and Vault Training) visually reinforces these concepts, showcasing a unified user interface where a deviation can trigger a CAPA, lead to direct training assignments, and initiate a change control, with all related activities and documents seamlessly linked. The demo also illustrates dynamic access security for external users, ensuring they only see relevant information, and highlights integrated reporting capabilities across all quality modules. The session concludes with best practices for transitioning to a unified system, emphasizing process harmonization, IT-business alignment, and a long-term strategic vision.

Key Takeaways:

• Industry Drivers for Quality Transformation: The life sciences industry is undergoing significant transformation driven by increasing regulatory complexity, global supply chains, externalization of manufacturing, rising product complexity (e.g., biologics, combination products), and frequent M&A activities, all of which necessitate more agile and unified quality systems.
• Challenges of Fragmented Systems: Many organizations still rely on outdated paper-based processes or multiple disconnected legacy QMS, document management, and training systems, leading to inefficiencies, data silos, inconsistent processes, and difficulties in maintaining compliance and agility.
• Benefits of Unified Cloud Solutions: Adopting a modern, true cloud-based quality system enables connected end-to-end processes, facilitates direct and secure third-party collaboration, and shifts the focus from reactive problem-solving to proactive quality management, ultimately driving speed, efficiency, and compliance.
• Internal Process Consolidation: A key opportunity lies in unifying disparate quality applications (e.g., document management, QMS, training) onto a single platform, allowing for intelligent data management and consolidation of fragmented QMS processes.
• Streamlining Change Control: Change control is a prime example of a complex process that greatly benefits from unification. A single platform can link quality events, CAPA, document updates, automated retraining, and control the release of changes, significantly reducing manual overhead and cycle times.
• Automated Quality Risk Management: Unified QMS enables automated and connected quality risk management, allowing for the logging and management of both proactive risks (from audits) and reactive risks (related to quality events) in a global register, facilitating actionable insights.
• QMS-ERP Integration: Integrating QMS with ERP systems provides a single source of truth for master data and automates critical processes like batch hold and release based on quality events, eliminating error-prone manual data interchange.
• Enhanced Third-Party Collaboration: Cloud technology simplifies secure, real-time collaboration with external stakeholders (suppliers, partners, customers) by extending granular access to specific parts of the quality system, overcoming the limitations and complexities of legacy on-premise integrations.
• Bi-directional Workflows and Audit Efficiency: External parties can participate directly in bi-directional workflows (e.g., reviewing batch documentation, collaborating on quality events) and auditors can be granted controlled, read-only access to specific documents or data, streamlining audit processes, especially for remote audits.
• Veeva Vault Quality Suite: This comprehensive suite unifies quality management through Vault QMS (for structured data, quality events, and workflows), Vault Quality Docs (for GxP document management), and Vault Training (for training matrices, curricula, and assignments), all operating on a single, consistent Vault platform.
• Dynamic Access Security: Granular control over information access for external users is achieved through dynamic access security, where permissions are based on metadata (e.g., product, facility, country) and can be automatically provisioned and deactivated for suppliers.
• Unified Reporting and Dashboards: The platform's robust reporting and dashboard capabilities allow for comprehensive insights by combining data from QMS, documents, and training, enabling users to drill down from high-level overviews to specific records and identify trends.
• Simplified Cloud Validation: For cloud systems like Veeva Vault, the vendor provides IQ/OQ (Installation Qualification/Operational Qualification) documentation, significantly reducing the customer's validation burden to primarily incremental PQ (Performance Qualification) testing or user acceptance testing with each release.
• Strategic Transition Approach: Companies embarking on a transition to a unified system should prioritize simplifying and harmonizing their business processes, foster a close working partnership between IT and business stakeholders, and select a vendor that aligns with their long-term vision for transformative quality management.

Tools/Resources Mentioned:

• Veeva Vault Quality Suite
• Veeva Vault QMS
• Veeva Vault Quality Docs
• Veeva Vault Training
• ERPs (Enterprise Resource Planning systems)
• ContractPharma.com (webcast archive)

Key Concepts:

• Unified Quality Management: The integration of all quality-related processes, data, and applications onto a single, cohesive platform to enhance efficiency, visibility, and regulatory compliance across an organization and its external partners.
• GxP Compliance: A set of "good practice" regulations (e.g., Good Manufacturing Practice, Good Clinical Practice) that ensure products are consistently produced and controlled according to quality standards appropriate for their intended use and as required by regulatory authorities.
• Change Control: A formal, documented process used to manage and track all proposed changes to validated systems, processes, or documents within a regulated environment to ensure product quality and patient safety are maintained.
• CAPA (Corrective and Preventive Actions): A system for identifying, investigating, and eliminating the causes of nonconformities or other undesirable situations, including both actions to correct existing problems and actions to prevent their recurrence.
• Dynamic Access Security: A security model that provides granular control over user access to data and documents by evaluating user attributes and data metadata in real-time, ensuring that individuals (especially external collaborators) only see information relevant and permissible to their role.
• Transversal Navigation: The ability within a unified system to seamlessly navigate and link between related records or applications, such as moving directly from a CAPA record to an associated change control, or from a change control to its impacted documents.

Examples/Case Studies:

• Change Control Process Unification: The video detailed how a quality event could trigger a CAPA, which in turn initiates a change control. This change control then seamlessly links to document updates (in Quality Docs) and automated retraining assignments (in Vault Training), with the release of updated documents and training completion coordinated by the change control process.
• QMS-ERP Integration for Batch Management: An example was provided where a quality event (e.g., deviation) in QMS could automatically pull impacted batch information from an ERP system, place those batches on hold in the ERP, and subsequently update their disposition based on the QMS workflow.
• External Collaboration for Batch Record Review: A scenario demonstrated how an external "sponsor" (customer) could be granted secure, granular access to a batch record in Vault Quality Docs to review and add annotations, with notifications sent to internal users.
• External Collaboration for Audit Finding Response: The demonstration illustrated how an external "supplier" could receive a task to respond to an audit finding directly within Vault QMS. The system automatically provisioned and subsequently deactivated their access, ensuring they only interacted with the specific finding assigned to them.