Beyond Digital: Taking a Data-Centric Approach to Validation Management

Validation management is a critical component of a company’s quality assurance framework, ensuring compliance by verifying that processes, systems, and equipment consistently meet regulatory and operational standards. But, the overreliance on manual processes can slow down projects and increase costs. In recent years, many companies have embraced digital transformation in validation management, adopting first-generation digital solutions to mitigate these challenges. While these traditional digital validation solutions digitized paper forms, their paper-on-glass approach replicates the data shortcomings of paper. They completely miss the goldmine of validation data that unlocks insights, automated in-application compliance controls, efficiency, and reporting.

Upgrades are often a heavy lift for first-generation digital validation solutions, limiting scalability options. For example, organizations often continue to operate with site-specific validation systems and processes. These variations are a burden to maintain, especially as validation teams face increasing workloads without corresponding headcount growth. They also pose a major compliance risk and make standardization across sites impossible.

Taking on higher project volumes while enhancing compliance

While first-generation digital validation solutions can help companies with audit readiness and collaboration, they do not provide the functionality to help execute and optimize the entire validation lifecycle. When every validation activity is captured as data, it unlocks capabilities and efficiencies that are not available in traditional digital validation approaches. A data foundation allows validation teams to maintain a system inventory, create and manage requirements at an object level, execute directly within the application, and automate the trackability matrix.

Some companies use their document management system to maintain validation processes and procedures. While this approach can support audit readiness and collaboration, configuration cannot compensate for missing capabilities. This creates limitations that prevent validation teams from taking on more projects at greater speeds.

Beyond simply digitizing documents, a data-centric approach also enables teams to work with requirements and test scripts on a granular level to save time and improve compliance. For example, when managing discrepancies, validation teams can begin versioning individual requirements and tracking where each has been tested across systems while gaining visibility into discrepancies logged against them.

With structured and accessible data in one central location, validation teams can easily generate insights and reports. For example, users can track progress and identify trends across the organization—like trending on types of testing discrepancies to improve the validation program. This real-time data allows companies to report on validation trends, track KPIs, and benchmark performance to ultimately improve efficiency and long-term compliance.

Faster validation at a lower cost

A data-centric approach helps quality leaders manage increasing workloads for equipment and software validation without additional headcount by:

• Increasing efficiency: Automating repetitive tasks improves collaboration while real-time data readiness accelerates timelines and frees up capacity.
• Strengthening compliance: Clear audit trails, reduced errors, and auto-generated documentation with relevant data and outcomes to ensure regulatory readiness with minimal manual effort.
• Optimizing planning: Real-time insights and time management enable better resource allocation, proactive scheduling, and reduce redundancy.

In particular, test authors and executors at manufacturing sites can benefit from data-centric validation. They can leverage existing data to decide what tests to perform, easily find and reuse tests, and automate workflows to ensure consistency. With real-time data entry, test authors and executors are no longer responsible for transcribing results to summary reports.

Real-time data and insights

With traditional digital validation approaches, validation managers cannot monitor and improve the end-to-end validation process. Data-centric validation unlocks powerful reporting capabilities to support continuous improvement. With real-time insights, quality teams have up-to-date visibility into validation activities to help them monitor progress and address issues promptly. This also helps enhance decision-making, allowing teams to identify trends, compare performance, and highlight areas for improvement.

When an inspector asks for validation documentation, a data-centric solution provides them quick access to relevant documentation and allows them to drill into the data. This ensures compliance with industry standards through automated, consistent reporting processes.

By investing in data-centricity, organizations can optimize their resources and lay a strong foundation for future innovation like automation, computer software assurance (risk-based validation), and AI. For example, validation teams can auto-generate document deliverables, status tracking, and traceability matrixes. Or, they can use risk-based practices to assess and categorize system functionalities based on their impact on patient safety and product quality. A data-centric digital validation solution also accelerates review by exception by automating data handling and focusing attention on anomalies.

The future of unified, data-centric validation

The industry is at an inflection point where more companies are removing legacy siloes to gain a global view of quality operations with increased efficiency and control across disciplines. As companies shift from legacy digital systems to modern platforms that unify quality processes, validation management is an area of great opportunity for modernization. Modern validation management is unified with quality processes and document management, accelerating project cycles by 50-70% to optimize validation beyond traditional digital approaches.

Learn how Vault Validation Management’s data-centric approach can streamline your validation processes, reduce cycle times, and ensure compliance.