2020 Veeva Quality Management Trends for Biopharma

This video provides an in-depth analysis of the quality management trends driving significant technological and operational transformation within the biopharmaceutical industry, particularly focusing on the shift away from legacy systems toward modern cloud solutions. Mike Jovanis, VP of Vault Quality at Veeva Systems, frames the historical context by noting that system adoption over the last two decades followed a "sine curve" pattern: periods of incremental investment followed by complacency, leading to a patchwork of aging technology across most organizations. This reactive, fragmented approach has resulted in over-engineered processes, corresponding manual workarounds, and a critical need for large-scale modernization.

The acceleration toward re-platforming and adopting multi-tenant, industry cloud software is driven by three primary factors. The first is the necessity for significant business process engineering and modernization. Many existing systems and processes were implemented reactively, creating inefficient, complex workflows that require expensive overhauls. The investment required for this process overhaul often justifies the simultaneous implementation of modern, unified technology platforms. The second critical driver is the reality of globalization and outsourcing. Modern organizations rely heavily on global suppliers, contract manufacturers, and various contract service providers. Legacy applications are fundamentally incapable of facilitating the necessary interactions and control required to maintain a unified quality picture across these third parties, forcing organizations to append additional manual processes around the system perimeter.

The third factor compelling transformation is simple technological obsolescence and the compelling benefits of unifying multiple disparate solutions onto a single platform. These combined pressures are leading to an acceleration of large-scale, transformative projects—a marked difference from the incremental investments of the past. These new initiatives require organizations to clearly understand and articulate the business value of the transformation, as they represent a major strategic shift rather than a simple system upgrade.

Looking ahead, the industry is predicted to look significantly different within the next few years. The speaker forecasts a widespread proliferation of cloud technology, the establishment of modern, standardized best practices across the sector, and the universal engagement of third-party partners and service providers directly within the core quality processes. This digital transformation aims to eliminate risk-adverse manual hand-offs, improve compliance, and ensure better communication and control across the entire global quality ecosystem.

Key Takeaways: • The End of Incremental Investment: The historical pattern of reactive, incremental investment in quality systems has created a landscape of legacy, patchwork technology that is no longer sustainable for modern global operations. • Justifying Transformative Projects: Organizations must shift from justifying small, incremental upgrades to demonstrating the clear business value of large-scale, transformative projects, which require significant process overhaul alongside technology adoption. • Three Drivers for Re-Platforming: The move to modern cloud solutions is primarily fueled by: 1) the need for business process engineering to eliminate over-engineered, manual workflows; 2) the requirement to digitally engage global suppliers and contract partners in quality processes; and 3) the obsolescence of aging technology. • Globalization Demands Digital Inclusion: Legacy quality applications fail to adequately facilitate interactions with global suppliers and contract manufacturers, necessitating the adoption of platforms capable of directly engaging these third parties to maintain regulatory control and visibility. • Cloud as the Unifying Solution: Multi-tenant, industry cloud software is emerging as the preferred solution for unifying multiple disparate quality systems onto a single platform, offering standardization and modernization benefits that legacy systems cannot match. • Process Modernization is Key: Technology implementation should be viewed as an opportunity to conduct significant business process engineering, moving away from reactive, over-engineered processes that often rely on manual workarounds. • Future State: Standardization and Control: The biopharma industry is moving toward a future defined by the proliferation of cloud technology, standardized best practices for quality management, and the universal, digital engagement of all external service providers within the quality ecosystem. • Eliminating Manual Hand-offs: Digitalization and automation are essential trends aimed at eliminating risk-adverse manual hand-offs and inefficient forms of information sharing, which currently cause delays and communication gaps between partners. • Focus on Quality, Compliance, and Operations: The ultimate goal of these transformative projects is to achieve simultaneous improvements in quality control, regulatory compliance adherence, and overall business operational efficiency.

Tools/Resources Mentioned:

• Veeva Vault Quality
• Multi-tenant and Industry Cloud Software

Key Concepts:

• Sine Curve of Incremental Investment: The historical pattern of technology adoption in quality management, characterized by periods of small investments followed by complacency, resulting in fragmented, outdated systems.
• Multi-tenant Cloud Software: Modern software architecture where a single instance of the software serves multiple customers, enabling rapid updates, standardized best practices, and easier integration across the industry.
• Business Process Engineering (BPE): The fundamental rethinking and redesign of business processes to achieve dramatic improvements in critical measures of performance, often necessitated by the inefficiencies created by reactively implemented legacy systems.