Re-Imagine your Veeva Validation Strategy with Opkey’s Automated Continuous Validation platform

This video provides an overview of how automated continuous validation platforms can transform the testing and compliance strategy for pharmaceutical companies utilizing Veeva systems. The core message centers on mitigating the regulatory burden and risks associated with Veeva configuration changes and updates by shifting from manual, periodic validation to an automated, continuous process. The speaker emphasizes that the current environment, accelerated by global events, necessitates a fundamental rethinking of traditional testing strategies to ensure ongoing compliance with applicable regulations, a critical requirement for GxP systems like Veeva CRM.

The solution presented focuses on proactively addressing common Veeva testing challenges, particularly the configuration validation burden that often slows down deployment and integration. By leveraging an automated platform, organizations can significantly reduce the time and effort required for validation. A key component of this strategy involves using pre-built validation packs, which allow organizations to achieve up to 70% faster validation cycles. This automation extends to seamlessly managing Process Qualification Status (PQS) and regression test suites, ensuring that every system change is thoroughly tested without extensive manual intervention.

A central technical feature highlighted is the use of smart Business Configuration Document (BCD) adapters, which are instrumental in automating configuration validation. This technology enables 100% data validation coverage with every system update. Furthermore, the platform incorporates real-time, risk-based impact analysis. This capability allows testing teams to identify exactly which parts of the system are affected by a change, enabling them to conduct the minimum necessary number of tests while achieving maximum coverage. This targeted approach is claimed to save an average of six weeks in testing time. Finally, the platform ensures comprehensive visibility through detailed standard and custom validation reports, helping organizations maintain an "always validated state" and strengthen adherence to regulatory demands.

Key Takeaways: • Automated Continuous Validation is Essential for Compliance: The traditional, manual testing strategy is insufficient for maintaining compliance in dynamic environments like Veeva, necessitating a shift to automated continuous validation to proactively address regulatory demands and mitigate operational risks. • Significant Reduction in Validation Burden: Implementing automated configuration validation solutions drastically reduces the manual effort associated with validating Veeva configurations, freeing up specialized resources for more strategic tasks. • Achieve 70% Faster Validation Cycles: By utilizing pre-built validation packs, organizations can accelerate their overall validation process, enabling quicker deployment of new Veeva features and configurations while maintaining regulatory rigor. • Seamless Automation of PQS and Regression Suites: The platform supports the seamless automation of both Process Qualification Status (PQS) and standard regression testing, ensuring that all critical business processes remain functional and compliant after system updates. • 100% Data Validation Coverage: Automated tools ensure complete data validation coverage with every Veeva update, eliminating blind spots and ensuring data integrity, which is crucial for GxP compliance. • Real-Time Risk-Based Impact Analysis: This capability allows testing teams to efficiently determine the scope of testing required following a change, focusing resources only on impacted areas and avoiding unnecessary full-suite testing. • Average Six Weeks Time Savings: The combination of automated testing and risk-based impact analysis ensures that organizations conduct the minimum number of tests for maximum coverage, resulting in substantial time savings, estimated at an average of six weeks per validation cycle. • Smart BCD Adapters Drive Configuration Automation: Specific adapters designed for Business Configuration Documents (BCDs) are key to automating the validation of Veeva configuration settings, ensuring accuracy and consistency across environments. • Maintain an "Always Validated State": The goal of continuous validation is to move beyond periodic validation checkpoints to a state where the system is perpetually compliant and ready for audit, significantly strengthening regulatory posture. • Enhanced Visibility through Reporting: The platform provides 100% visibility into the validation status through detailed standard and custom reports, which are essential for audit trails and demonstrating compliance to regulatory bodies.

Tools/Resources Mentioned:

• Opkey: The automated continuous validation platform.
• Veeva: The enterprise platform (implied Veeva CRM) requiring validation.
• Pre-Built Validation Pack: A resource provided by the platform to accelerate initial validation setup.
• Smart BCD Adapters: Specific tools used for automating the validation of Veeva Business Configuration Documents.

Key Concepts:

• Continuous Validation: A methodology where validation activities are integrated throughout the software development and deployment lifecycle, ensuring that the system remains in a validated state continuously, rather than only after major updates.
• Risk-Based Impact Analysis: A technique used to analyze the potential impact of a system change and determine the minimum set of tests required to confirm system integrity and compliance, maximizing coverage while minimizing testing time.
• PQS (Process Qualification Status): Refers to the qualification and validation of the specific business processes executed within the regulated system, a critical component of GxP compliance.
• Veeva Configuration Validation: The process of ensuring that the specific settings, customizations, and configurations made within the Veeva platform meet regulatory requirements and function as intended.