Unifying Quality Processes in a Single System to Improve User Experience

This video provides an in-depth case study on how the pharmaceutical company UCB successfully implemented Veeva Vault QualityDocs to consolidate disparate quality management systems, significantly improving user experience and operational efficiency. The primary motivation for UCB was the difficulty in keeping critical processes up-to-date across multiple platforms. Recognizing that their challenges spanned not only quality documentation but also regulatory submissions and Electronic Trial Master File (eTMF) management, UCB sought a single vendor capable of connecting all three domains, ultimately leading them to choose Veeva Systems.

The transition represented a significant shift for UCB, moving from traditional on-premise solutions to a cloud-based environment. The core benefit derived from this migration was the unification of systems; UCB successfully reduced four separate quality documentation systems down to a single instance of Veeva QualityDocs. This consolidation allowed the organization to pivot its focus entirely. Instead of dedicating resources to continuous bug fixing and maintenance of legacy systems, teams could now concentrate on strategic improvements, enhancements, and optimizing the overall user experience within the new platform.

A critical enhancement highlighted by the speaker is the platform’s ability to facilitate seamless collaboration with external partners and vendors. Utilizing the cloud solution, UCB was able to grant specific access to external entities for two key tasks: securely sharing documents and allowing them to review and approve documents directly within the system. This integration drastically streamlined the document lifecycle, replacing the cumbersome, months-long process of sending documents via email for sign-off with an instant, efficient, and auditable digital workflow. The speaker strongly advocates for the cloud-based approach, emphasizing that the ease of system validation and the quick learning curve for end-users contribute directly to tangible efficiencies and faster job completion.

Key Takeaways:

• System Consolidation as a Strategic Priority: UCB's initial challenge was managing outdated processes across multiple systems (four separate quality documentation platforms), leading to inefficiencies. The strategic decision to unify these into a single system (Veeva QualityDocs) was crucial for operational improvement.
• Shifting Focus from Maintenance to Enhancement: By adopting a modern cloud solution, UCB was able to redirect internal resources away from reactive "bug fixing" of legacy systems toward proactive efforts focused on improving user experience, enhancing workflows, and tackling complex networking topics.
• Integrated Platform Value Proposition: The decision to choose Veeva was driven by its ability to connect critical regulated functions—Quality, Submissions, and eTMF—within a unified ecosystem, demonstrating the value of integrated enterprise solutions in life sciences.
• Streamlining External Partner Collaboration: Veeva QualityDocs enabled UCB to securely integrate external vendors and partners into their quality processes. This included allowing external parties to share, review, and approve documents directly in the cloud environment.
• Accelerated Compliance Workflows: The implementation drastically reduced the time required for document review and approval cycles. The transition from lengthy, four-month email-based sign-off processes to instant, digital approvals represents a major gain in efficiency and compliance speed.
• Benefits of Cloud Adoption in Regulated Environments: The speaker specifically recommends cloud-based solutions, citing two major advantages: the simplified validation process inherent to modern cloud platforms and the inherent ease of use, which accelerates user adoption and overall efficiency.
• Focus on User Experience (UX): The project’s success was measured not just by consolidation but by the ability to "improve and enhance the user experience," suggesting that modern regulated software must prioritize intuitive design to maximize adoption and compliance adherence.
• Leveraging Networking Capabilities: UCB utilized the new system to improve internal and external networking, allowing them to develop new functionalities and easily integrate partners and vendors into controlled document workflows.

Tools/Resources Mentioned:

• Veeva Systems: The primary vendor and platform provider.
• Veeva Vault QualityDocs: The specific product implemented for unifying quality documentation processes.
• Veeva Vault eTMF (Electronic Trial Master File): Mentioned as one of the three critical areas (alongside Quality and Submissions) that UCB sought to unify under the Veeva platform.

Key Concepts:

• System Unification: The strategic process of consolidating multiple, disparate software systems (in this case, four quality systems) into a single, integrated platform to reduce complexity, improve data integrity, and lower maintenance costs.
• Cloud Solution Validation: Refers to the process of ensuring that a cloud-based software system meets regulatory requirements (like GxP and 21 CFR Part 11). The speaker notes that cloud solutions offer advantages in simplifying this often complex and resource-intensive process compared to on-premise systems.
• External Partner Collaboration: The ability to securely and compliantly extend document control and approval workflows to third-party vendors, CROs, or contract manufacturers, eliminating manual, non-compliant communication methods like email.

Examples/Case Studies:

• UCB Implementation: A case study detailing how the pharmaceutical company UCB moved from four separate quality systems to a single instance of Veeva QualityDocs to address issues with process currency and system maintenance.
• Document Approval Efficiency: A concrete example of efficiency gain where document sign-offs, which previously took up to four months via email, became instant and automated within the new cloud platform.