Veeva Configuration Validation

This video provides an in-depth analysis of the critical challenge of configuration validation and change management within Veeva environments across the pharmaceutical and life sciences industries. The central theme is the difficulty industry experts face in establishing that the intended use of their Veeva instance remains GxP compliant across end-to-end systems following configuration changes or deployments. While Veeva offers foundational validation packages (IQ and OQ) that customers can leverage, a significant gap remains in performing comprehensive, continuous compliance analysis across the entire platform, requiring detailed standard and custom validation reports generated against every requirement document.

The presentation introduces Opkey as an industry-leading automated validation platform specifically designed for Veeva CRM and Veeva Vault. This platform addresses the manual complexity and time sink associated with traditional validation processes by offering pre-built automated validation packs and an impact-driven risk assessment methodology. The core value proposition is shifting the validation strategy from periodic, resource-intensive efforts to a continuous validation model. This automated approach seamlessly extends beyond the initial Installation Qualification (IQ) and Operational Qualification (OQ) stages to include Performance Qualification (PQ), regression testing, and security test validations, ensuring ongoing compliance with every release and configuration update.

A key technical feature highlighted is the platform's ability to integrate with customer-specific Business Configuration Document (BCD) formats, supporting multiple configuration file formats essential for regulatory customers. This capability allows for the generation of custom validation reports, including vital configuration comparison analysis across multiple instances (e.g., development, staging, production). Furthermore, the solution facilitates regulatory review by allowing the export of pre- and post-execution reports and integrates with Application Lifecycle Management (ALM) platforms for efficient test mapping and review processes. By automating these traditionally manual and error-prone steps, the platform promises substantial improvements in business outcomes and regulatory adherence.

The implementation of this automated validation strategy yields significant measurable efficiency gains. The platform claims to provide 70% faster overall validation time, resulting in an average time saving of six weeks per configuration change cycle. Furthermore, it ensures 100% data validation coverage for each configuration cycle and achieves a reduction in the overall regression cycle time by over 50%. These metrics underscore the platform's role in accelerating the deployment of necessary configuration changes while maintaining stringent GxP compliance standards, allowing life sciences companies to remain agile without compromising regulatory integrity.

Key Takeaways:

• GxP Compliance Challenge in Change Management: A major hurdle in the life sciences sector is ensuring continuous GxP compliance across end-to-end systems following any configuration changes or deployments within Veeva CRM or Veeva Vault instances.
• Limitations of Standard Validation: While Veeva provides foundational IQ (Installation Qualification) and OQ (Operational Qualification) packages, these often do not cover the full spectrum of end-to-end compliance analysis required, necessitating extensive custom validation efforts.
• Shift to Continuous Validation: The industry must move beyond traditional, periodic validation processes toward a continuous validation strategy that incorporates PQ (Performance Qualification), comprehensive regression testing, and security validations with every configuration update.
• Impact-Driven Risk Assessment: Automated platforms leverage impact-driven risk assessment to identify and prioritize critical tests that must be executed, streamlining the validation process and focusing resources where regulatory risk is highest.
• Automation for Efficiency: Automated validation platforms, utilizing pre-built validation packs, significantly accelerate the compliance timeline, claiming up to 70% faster validation and an average saving of six weeks per configuration change cycle.
• Comprehensive Data Coverage: Automated solutions ensure 100% data validation coverage for every configuration cycle, drastically reducing the risk of non-compliance stemming from incomplete or missed validation steps.
• Regression Cycle Reduction: Automation is critical for commercial operations, as it can reduce the overall regression cycle time by over 50%, allowing commercial teams to implement necessary system changes faster and maintain operational continuity.
• Support for Regulatory Documentation: The automated solution must be capable of understanding and adapting to customer-specific Business Configuration Document (BCD) formats and generating custom validation reports required for regulatory submissions.
• Configuration Comparison Analysis: A vital feature for maintaining compliance is the ability to perform configuration comparison analysis across multiple Veeva instances (e.g., comparing development to production environments) to ensure consistency and control.
• Integration with ALM Platforms: Seamless integration with Application Lifecycle Management (ALM) platforms is necessary for efficient test mapping, review, and audit trail management, ensuring that validation activities are fully traceable and compliant with 21 CFR Part 11 requirements.

Tools/Resources Mentioned:

• Veeva CRM
• Veeva Vault
• Opkey (Automated Validation Platform)
• ALM Platforms (Application Lifecycle Management)

Key Concepts:

• Configuration Validation: The process of ensuring that changes made to a software system's settings or configuration meet specified requirements and maintain the system's intended use, particularly critical in regulated environments.
• GxP Compliance: A set of quality guidelines and regulations (including Good Clinical Practice, Good Manufacturing Practice, etc.) that ensure products are safe, meet quality standards, and are accurately documented, mandatory for the life sciences industry.
• IQ, OQ, PQ (Installation, Operational, Performance Qualification): The three phases of validation. IQ confirms the system is installed correctly; OQ confirms the system operates according to specifications; PQ confirms the system performs consistently under actual use conditions.
• Continuous Validation: A modern strategy where validation activities are integrated into the development and deployment lifecycle, ensuring that the system remains in a validated state with every change or update, rather than relying on large, infrequent validation projects.
• Business Configuration Document (BCD): A document detailing the specific settings, rules, and configurations applied to an enterprise software instance (like Veeva) to meet the business requirements of the organization.