Kyle Boelter | On-the-Job Training Effectiveness w/ Vault Training - Register for Summit on Oct. 14

This video serves as a preview for a specialized session focusing on optimizing On-the-Job Training (OJT) effectiveness using the Veeva Vault Training application. Presented at the Veeva R&D and Quality Summit, the demonstration centers on how pharmaceutical and life sciences organizations can leverage this platform to manage, track, and verify the critical skills and qualifications required for personnel working in regulated environments. The core objective is to showcase the application’s ability to move beyond simple course completion tracking to robust, verifiable skill qualification, which is essential for maintaining GxP compliance and operational integrity.

The session highlights specific functionalities within Vault Training designed to streamline the qualification process. A key focus is the ability for both training administrators and managers to meticulously track various forms of personnel readiness, including formal qualification status, professional certifications, and completion of specific skill or task-based assignments. This tracking capability is vital for ensuring that employees are not only trained but are demonstrably competent before engaging in critical, regulated activities. The system facilitates a structured approach to OJT by integrating the verification step directly into the workflow, moving away from manual sign-offs and disparate systems.

Central to the demonstrated value is the role of the evaluator. The Vault Training application provides a mechanism where a designated evaluator—typically a subject matter expert or supervisor—can formally verify the learner's ability in a specific area of the business. This verification step transforms training completion into documented qualification, providing an auditable record that confirms the learner has successfully demonstrated the required skill or task proficiency. By centralizing this process, companies gain immediate visibility into workforce readiness, significantly improving audit preparedness and reducing the risk associated with unqualified personnel performing regulated tasks in R&D, manufacturing, or quality assurance environments. The session ultimately aims to illustrate how integrated digital tools can transform compliance training from a bureaucratic hurdle into a strategic asset for quality management.

Key Takeaways:

• Centralized OJT Management: The Veeva Vault Training application provides a unified platform for managing all aspects of On-the-Job Training (OJT), moving away from decentralized, paper-based, or spreadsheet-driven tracking methods common in regulated industries.
• Qualification vs. Completion: The system emphasizes the distinction between simple training completion (attending a course) and verifiable qualification (demonstrating competence), which is crucial for meeting stringent GxP and regulatory requirements.
• Auditable Skill Verification: A core function is the ability for a designated evaluator to formally verify a learner's ability in a specific skill or task, creating an immutable, auditable record required for regulatory inspections (e.g., FDA 21 CFR Part 11 compliance).
• Tracking Comprehensive Readiness: Managers and administrators gain the capability to track multiple types of readiness metrics simultaneously, including formal qualifications, external certifications, and internal task-based assignments, providing a holistic view of workforce competency.
• Improved Compliance Posture: By digitizing and standardizing the OJT qualification process, organizations can significantly enhance their audit readiness, ensuring that all personnel performing regulated activities have documented proof of current and verified training status.
• Integration Opportunity for AI/Data: The structured data generated by Vault Training (qualification status, evaluator feedback, skill gaps) presents a prime opportunity for integration with Business Intelligence (BI) dashboards and AI solutions, allowing for predictive analysis of training needs and compliance risk.
• Enhanced Operational Efficiency: Automating the tracking and notification processes for re-qualification and certification expiration reduces administrative overhead for training departments and ensures continuous compliance without manual intervention.
• Focus on Task-Based Assignments: The platform supports the management of highly specific, task-based training assignments, allowing organizations to tailor OJT to precise operational roles within manufacturing, laboratory, or clinical settings.
• Strategic Value of Training Data: Data collected on training effectiveness and qualification rates can be used strategically to identify systemic skill gaps across the organization, informing future curriculum development and resource allocation.
• Veeva Ecosystem Leverage: Utilizing Vault Training ensures seamless integration with other Veeva Vault applications (e.g., QualityDocs, QMS), creating a connected digital quality and compliance infrastructure that IntuitionLabs.ai can further optimize with custom software and AI agents.

Tools/Resources Mentioned:

• Veeva Vault Training: The specific application within the Veeva Vault suite designed to manage and track training, qualification, and certification requirements, particularly for R&D and Quality functions.
• Veeva R&D and Quality Summit: The industry event where this session was presented, highlighting the platform's focus on the regulated aspects of the life sciences pipeline.

Key Concepts:

• On-the-Job Training (OJT): Practical training received while performing job duties, often requiring formal verification of competence by a supervisor or expert.
• Qualification: The formal process of verifying and documenting that an individual has the necessary skills, knowledge, and experience to perform a specific regulated task or role, often required under GxP regulations.
• Certification: Formal recognition, often external or internal, that an individual has met predefined standards or passed specific examinations related to a skill or profession.