Extending Quality Processes to Your Global Workforce

This video provides an in-depth exploration of extending quality processes to a global workforce using Veeva Vault QualityDocs. Jeff Shiran, a Sales Engineer for R&D at Veeva, demonstrates how the Vault platform facilitates compliant and collaborative document management within the pharmaceutical and life sciences industries. The presentation highlights the unique advantages of Vault's cloud-based architecture, emphasizing its built-in compliance features and user-friendly design, which are crucial for managing GxP documents and ensuring regulatory adherence across diverse teams and external partners.

The core of the discussion revolves around three main pillars: accessibility, consumer web design, and a multi-tenant cloud solution. Vault's web-browser accessibility allows users to interact with the system from any device, promoting flexible work arrangements. The platform's design draws inspiration from consumer web experiences, making it intuitive to find and manage documents, akin to online shopping platforms. Furthermore, as a multi-tenant cloud solution, Veeva Vault ensures all clients are on the same version, enabling rapid innovation and significantly reducing the validation burden traditionally associated with regulated enterprise software.

A significant portion of the demonstration focuses on secure collaboration with both internal and external stakeholders. Shiran illustrates how Vault can manage granular permissions for different user types, from internal quality directors and associates to external consultants and contract manufacturing organizations (CMOs). The system allows for controlled sharing of documents, ensuring that external parties only access content explicitly permitted, and crucially, all interactions, even with non-Vault users via shared links, are meticulously tracked through a robust audit trail. This capability addresses critical security and compliance concerns, preventing documents from leaving the controlled environment without traceability.

The demo walks through practical scenarios, including creating and authoring GxP documents, managing review and approval workflows, and utilizing dashboards for real-time insights into document status and overdue tasks. Shiran showcases how document properties can automate workflows and how the system auto-generates viewable PDF renditions, eliminating the need for native software. The session concludes by addressing security concerns, emphasizing how Veeva's cloud infrastructure and inherent auditability enhance compliance and reduce the risk of uncontrolled document sharing compared to older, VPN-dependent systems.

Key Takeaways:

• Veeva Vault's Inherent Compliance: The Vault platform is designed from the ground up for life sciences, incorporating features like 21 CFR Part 11 compliant signatures, PDF publishing, and robust audit trails, eliminating the need for retrofitting generic systems.
• Global Accessibility and Device Independence: Users can access Veeva Vault QualityDocs from any device (PC, Mac, mobile) with just an internet connection and a web browser, facilitating collaboration across a geographically dispersed workforce.
• Intuitive User Experience: Leveraging "consumer web design" principles, Vault offers an easy-to-use interface for finding and managing documents, improving user adoption and reducing the learning curve.
• Multi-Tenant Cloud Benefits: Being a multi-tenant cloud solution allows Veeva to rapidly innovate and deploy new features, while also significantly lessening the validation burden for client companies.
• Granular Permission Management: Vault enables precise control over document access and functionality for various user roles, including internal employees (e.g., Director of Quality, Quality Associate) and external partners (e.g., consultants, CMOs).
• Secure External Collaboration: The system facilitates collaboration with third parties by allowing controlled sharing of specific documents, ensuring external users only see what is intended and for a defined period.
• Robust Audit Trail for All Interactions: Every action within Vault, including viewing and downloading documents by external, non-Vault users via shared links, is meticulously recorded in a date and time-stamped audit trail, enhancing traceability and compliance.
• Automated Document Workflows: Document properties (e.g., site, department) can be leveraged to automatically trigger specific review and approval workflows, streamlining quality processes.
• Inline Document Viewing and Rendition Generation: Users can view documents in an inline browser without needing native software (e.g., Microsoft Word), and Vault automatically generates viewable PDF renditions of source documents.
• Flexible Document Creation: Users can create new documents from pre-defined templates or upload existing documents from their local systems, with options to classify content later if initial information is incomplete.
• Actionable Business Intelligence Dashboards: Configurable dashboards provide real-time insights into document status (e.g., by facility) and overdue tasks, allowing for proactive management and global/local oversight.
• Enhanced Security and Auditability: The cloud-based system offers superior security and auditability compared to legacy systems, preventing uncontrolled document sharing (e.g., via thumb drives) and improving overall compliance.
• Improved User Acceptance for Compliance: An easy-to-use system like Vault tends to have higher user acceptance, which in turn leads to better compliance as users are less likely to circumvent the system.

Tools/Resources Mentioned:

• Veeva Vault QualityDocs
• Veeva Vault Platform
• Microsoft Word (for document authoring)
• Google Chrome (web browser used in demo)

Key Concepts:

• GxP (Good Practice): A set of regulations and guidelines for manufacturing, testing, and distributing pharmaceutical products, ensuring quality and safety.
• 21 CFR Part 11: Regulations from the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• Multi-tenant Cloud Solution: A single instance of a software application that serves multiple customers (tenants), where data is segregated but all tenants share the same infrastructure and application version. This enables faster updates and shared security investments.
• Audit Trail: A chronological record of system activities, including who accessed what, when, and what changes were made, essential for regulatory compliance and accountability.
• Viewable Rendition: An automatically generated, non-editable version (typically PDF) of a source document, used for viewing and sharing without altering the original.
• Inline Browser: A feature that allows users to view documents directly within the web application interface without downloading them or opening them in external software.
• Consumer Web Design: Applying principles of user-friendly, intuitive design common in consumer-facing websites to enterprise software to enhance usability and adoption.

Examples/Case Studies:

• User Role Demonstrations: The demo featured four distinct user roles to illustrate permission control:
  • Ken Quality (Director of Quality): A Vault user with high-level access, able to see all documents, create, upload, and manage reports/dashboards.
  • Rich Reviewer (Quality Associate): An internal Vault user with limited access, able to see documents only for his specific site, and perform review/annotation tasks.
  • Bob External (External User/Consultant): An external Vault user with very limited access, only able to see specific assigned documents and perform review/annotation, with no access to reports, dashboards, or creation/upload functions.
  • Jeff CMO (Contract Manufacturing Associate): A non-Vault user who receives a time-limited, trackable link to view a document, with all his interactions (viewed, downloaded) recorded in Vault's audit trail.
• Document Workflow: Illustrated the process of creating an SOP from a template, checking it out for authoring in Microsoft Word, checking it back in, and initiating a review and approval cycle involving different internal and external users.
• Dashboard Reporting: Showcased a "Global Dashboard" for document status across the enterprise, with the ability to filter by specific sites (e.g., Chicago) and identify overdue tasks and the responsible individuals.
• Security Feedback: A client anecdote highlighted how Vault's audit trail and controlled access prevented the common issue of employees putting sensitive documents on thumb drives or emailing them outside the system for home access, thereby enhancing security and compliance.