Broadening Quality Management with Vault QMS at Atrium Innovations

This video details Atrium Innovations' strategic expansion of their quality management system (QMS) using Veeva Vault, moving from static document control to integrated, action-level process management. James Huang, Director of Global Quality Systems, outlines how the company initially leveraged Vault QualityDocs for managing quality documents and GxP records across 14 global sites, establishing a single source of truth and robust authority control. The core value derived from this initial implementation centered on four primary areas: connected collaboration across sites, global transparent information sharing, secure storage and archiving, and immediate availability of documents during audits. This foundation set the stage for a significant milestone: the implementation of Vault QMS to handle event-level actions, change control, and overall workflow management.

The transition to Vault QMS represents a shift from merely managing static information (documents) to actively managing events and actions within the quality lifecycle. This integrated approach allows Atrium to link tasks directly to individuals, track the status of quality events to conclusion, and enforce life cycle rules, thereby creating a more collaborative and unified system globally. A critical application of this expanded QMS is extending quality management beyond Atrium’s "four walls" to include third-party manufacturers and the entire supply chain. By integrating suppliers into the system for qualification, defect tracking, and change control, Atrium aims to improve quality across the entire supply chain, not just internally.

Furthermore, the implementation of Vault QMS is leveraged as a powerful workload management tool, a functionality not originally anticipated but highly valued. By utilizing the system's dashboard capabilities, Atrium gains transparency into process progress, eliminating the ambiguity common with older, folder-based systems where progress claims were difficult to verify. This transparency allows management to track the movement of documents and tasks, ensuring accountability and driving processes forward. Atrium Innovations is also implementing Vault for registration and submission modules alongside QMS, emphasizing the power of a "connected and unified" Veeva ecosystem where the entire product lifecycle—from application submission to documentation—is seamlessly linked.

Key Takeaways: • Transition from Static to Action-Oriented QMS: Companies should evolve their quality systems beyond simple document storage (like QualityDocs) to event-level management (like QMS) to handle change control, CAPAs, and deviations, ensuring tasks are linked to specific individuals and followed through their complete lifecycle. • Supply Chain Quality Integration: Modern QMS implementation must extend beyond internal operations to include third-party manufacturers and suppliers. Integrating suppliers into the system allows for unified qualification processes, defect tracking, and collaborative change control, fostering quality improvement across the entire supply chain. • Four Pillars of Global QMS Value: The primary benefits of a unified global QMS system are: 1) Connected collaboration across all sites; 2) Global, transparent information sharing; 3) Secure, worry-free storage and archiving; and 4) Immediate availability of information for audits and regulatory inquiries. • QMS as a Workload Management Tool: Beyond its core regulatory function, a modern QMS platform can be leveraged for workload management and transparency. Dashboards and status tracking eliminate the "no transparency" issues of legacy systems, allowing managers to monitor task progress and ensure accountability globally. • Harmonization through Technology: Implementing a unified technology platform like Veeva Vault provides a critical opportunity to harmonize disparate business processes across different global sites, ensuring consistency in quality operations and regulatory adherence. • Importance of a Unified Ecosystem: Implementing QMS alongside other modules, such as Registration and Submission, creates a powerful "connected and unified" ecosystem. This integration ensures that quality events and documentation are seamlessly linked to regulatory submissions and product applications, providing end-to-end visibility. • Audit Readiness and Availability: A key value proposition of cloud-based, controlled document management systems is the immediate availability of required information during audits, significantly streamlining the compliance verification process. • Change Control Integration: The ability to link change control processes directly to specific tasks and individuals within the QMS is crucial for maintaining compliance and ensuring that changes are thoroughly reviewed, approved, and implemented across all involved parties (internal and external).

Tools/Resources Mentioned:

• Veeva Vault QualityDocs
• Veeva Vault QMS (Quality Management System)
• Veeva Vault Registration and Submission modules

Key Concepts:

• Global QMS Implementation: The process of deploying a single, standardized Quality Management System across multiple international sites to ensure process harmonization and compliance consistency.
• Connected and Unified System: The concept of integrating various functional modules (e.g., Quality, Regulatory, Submissions) within a single platform (Veeva Vault) to ensure seamless data flow and end-to-end process visibility.
• Event-Level Management: Moving beyond static document control to actively manage quality events (e.g., deviations, CAPAs, change controls) through defined workflows, task assignments, and lifecycle tracking.