Veeva Testing Update

This video provides an in-depth overview of a continuous validation platform designed specifically to address the unique testing and compliance challenges posed by Veeva Systems within the highly regulated pharmaceutical industry. The core premise is that the traditional, manual testing strategies are insufficient given Veeva’s schedule of three major software releases per year. These frequent updates and configuration changes inherently risk altering the validated state of critical workflows, specifically impacting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation, thereby exposing businesses to unnecessary regulatory risk.

The solution presented centers on leveraging Artificial Test Intelligence (ATI) and predictive analytics to transform the validation process from a reactive, time-consuming effort into a proactive, continuous function. The platform is explicitly marketed as GxP compliant and 100% validated, positioning it as a necessary tool for environments requiring strict adherence to regulatory standards. By automating the identification of change impact, the system ensures that only the necessary tests are executed, maximizing coverage while minimizing the time spent on validation. This approach is crucial for maintaining the "fit for intended use" status required by regulatory bodies.

A key component of the platform is the provision of a comprehensive, pre-built validation pack containing over 350 self-learning, fully automated tests. This ready-to-use resource is claimed to achieve validation up to 70% faster than traditional methods. Furthermore, the platform automates the generation of Validation Compliance Documents (VCDs) and performs configuration validation with every change, ensuring that the system remains compliant even as configurations evolve. The emphasis is placed on impact-driven risk assessment, which utilizes real-time analysis to conduct a minimum number of tests for maximum coverage, resulting in an average time saving of six weeks per release cycle. Finally, the platform ensures full traceability and audit readiness by integrating seamlessly with test management tools like ALM and Jira, providing detailed standard and custom validation reports with 100% audit visibility.

Key Takeaways: • Necessity of Continuous Validation for Veeva: Due to Veeva Systems' commitment to three major software releases annually, continuous testing is mandatory to prevent configuration changes from disrupting validated IQ, OQ, and PQ workflows, which could lead to non-compliance. • GXP Compliance as a Core Feature: The platform is designed from the ground up to be GxP compliant and fully validated, addressing the strict regulatory requirements of the pharmaceutical and life sciences sectors. • Accelerated Validation Metrics: Utilizing pre-built, self-learning validation packs (350+ tests) allows organizations to achieve validation up to 70% faster than manual or traditional automated methods. • AI-Driven Risk Assessment: The platform employs Artificial Test Intelligence (ATI) and predictive analytics to perform real-time, risk-based impact analysis, identifying exactly which tests are required after an update to ensure maximum coverage with the minimum testing effort. • Significant Time Savings: By focusing testing efforts based on predictive impact analysis, the platform claims to save an average of six weeks of validation time per Veeva release cycle. • Automated Documentation and Traceability: The system automates the generation of Validation Compliance Documents (VCDs) and ensures configuration validation with every change, streamlining the documentation burden associated with regulatory audits. • 100% Data Validation Coverage: The platform is designed to ensure complete data validation coverage with every Veeva update, a critical requirement for maintaining data integrity and regulatory adherence (e.g., 21 CFR Part 11). • Seamless Integration with Test Management: Full integration with Application Lifecycle Management (ALM) tools like Jira allows for automated reporting of results and the generation of 100% audit reports, providing comprehensive visibility into the validation status. • Maintaining the Validated State: The primary goal of continuous validation is to assure that the Veeva system remains "fit for intended use" and compliant with all applicable regulations, despite frequent vendor-driven and internal configuration changes. • Focus on Commercial Operations Stability: By ensuring the stability and compliance of Veeva CRM—a core commercial operations tool—the platform mitigates business risk associated with system downtime or regulatory penalties.

Tools/Resources Mentioned:

• Opkey (The continuous validation platform)
• Veeva Systems (The application being tested)
• ALM (Application Lifecycle Management)
• Jira (Test management and reporting tool)

Key Concepts:

• Continuous Testing/Validation: The practice of testing and validating software frequently throughout the development and release lifecycle, rather than only at the end, which is essential for systems with frequent updates like Veeva.
• GxP Compliance: A general term for Good Practices (Good Manufacturing Practice, Good Clinical Practice, etc.) that ensures products are consistently produced and controlled according to quality standards appropriate to their intended use and as required by regulatory bodies.
• IQ/OQ/PQ (Installation, Operational, Performance Qualification): The three phases of validation required in regulated environments to demonstrate that equipment or systems are installed correctly, operate according to specifications, and perform consistently under actual use conditions.
• VCD (Validation Compliance Document): Documentation generated to prove that a system or configuration change has been validated and meets regulatory compliance standards.
• Artificial Test Intelligence (ATI): The use of AI and machine learning to optimize the testing process, including identifying necessary tests, predicting change impact, and generating test scripts.