Anastasia Wengrowski | Improving External Collaboration w/ Vault QMS - Register for Summit on Oct 14

This video announces an upcoming session at the Veeva R&D and Quality Summit, focusing on optimizing quality management processes through enhanced external collaboration using Veeva Vault QMS. The presentation, led by Anastasia Wengrowski, is designed as an interactive demo session centered on a specific, high-value feature: the "audit finding external response collaboration feature." The core purpose of the session is to demonstrate how organizations within the life sciences sector can leverage this functionality to achieve seamless cooperation between internal quality teams and external stakeholders when addressing critical audit findings.

The central theme addresses a significant challenge in regulated industries: the need to securely and compliantly manage responses to regulatory or internal audit observations that require input from third parties, such as contract manufacturing organizations (CMOs), contract research organizations (CROs), or key suppliers. By focusing on the Vault QMS collaboration feature, the session implies a shift away from traditional, often fragmented methods (like email chains and uncontrolled document sharing) toward a standardized, auditable, and centralized system. This is crucial for maintaining GxP compliance, as every step in the corrective and preventive action (CAPA) process, including external input, must be fully documented and traceable.

The session promises to show attendees how Vault QMS drives efficiency by integrating these external parties directly into the workflow for responding to audit findings. This direct integration ensures that external responses are captured within the validated system, accelerating the turnaround time for remediation and final submission to regulatory bodies. The emphasis on "seamless collaboration" suggests that the demo will highlight how the platform manages user permissions, document version control, and automated audit trails, ensuring data integrity and regulatory adherence while simplifying the complex process of cross-organizational quality resolution. For pharmaceutical and biotech companies, mastering this collaboration is essential for minimizing compliance risk and ensuring continuous operational readiness.

Key Takeaways: • Streamlining Audit Response Workflows: The primary focus is on utilizing Vault QMS to standardize and accelerate the process of gathering, reviewing, and approving responses to audit findings, particularly when those responses require input from external partners or vendors. • Centralized Compliance Management: Vault QMS serves as the single source of truth for all quality documents and processes, ensuring that external contributions to audit remediation are captured within a 21 CFR Part 11 compliant environment, critical for maintaining regulatory integrity. • Addressing External Stakeholder Pain Points: The "audit finding external response collaboration feature" directly solves the common industry challenge of securely sharing sensitive quality data and receiving documented feedback from non-internal users without compromising data security or auditability. • Accelerated CAPA Implementation: By facilitating faster and more organized external input, the feature helps organizations expedite the initiation and closure of Corrective and Preventive Actions (CAPAs), thereby reducing the overall timeline for quality issue resolution and minimizing regulatory exposure. • Interactive Demonstration Focus: The session format suggests a practical, hands-on approach, likely detailing the specific user interface and workflow steps required for internal quality managers to initiate collaboration requests and for external parties to submit their responses within the Vault environment. • Importance for GxP Environments: Effective use of this collaboration tool is vital for organizations operating under GxP regulations, as it ensures that all external activities impacting product quality or clinical data integrity are properly controlled, documented, and traceable. • Reducing Reliance on Uncontrolled Communication: The system aims to eliminate the risks associated with using non-validated communication methods (like email or generic file-sharing services) for critical quality documentation, enhancing control over document versioning and approval processes. • Strategic Value for Quality Operations: Implementing robust external collaboration features within a QMS is a strategic move that improves the efficiency of commercial operations and clinical trials by ensuring that quality bottlenecks caused by partner communication delays are proactively managed.

Tools/Resources Mentioned:

• Veeva Vault QMS (Quality Management System)
• Veeva R&D and Quality Summit (Event Context)

Key Concepts:

• Vault QMS: A cloud-based quality management application designed specifically for the life sciences industry, managing processes like deviations, CAPAs, change control, and audits in a compliant manner.
• Audit Finding External Response Collaboration Feature: A specific functionality within Vault QMS that enables secure, controlled interaction and documentation exchange with third-party stakeholders regarding the remediation and response to quality audit observations.
• External Collaboration: The process of efficiently and compliantly working with partners outside the immediate organization (e.g., suppliers, CROs, CDMOs) to resolve quality issues, ensuring all actions are documented according to regulatory standards (e.g., GxP).