Generation Veeva | Meet Dianne: At Home with Veeva

This video provides a practical, day-in-the-life perspective of an Associate Consultant at Veeva, offering significant insight into the operational realities of implementing regulated enterprise software within the life sciences industry. The narrative focuses heavily on the specific projects, validation activities, and compliance requirements that dominate the daily workload of a consultant specializing in the Veeva Vault ecosystem. The routine emphasizes the structured, focused nature of consulting work, balancing individual deep work on compliance documentation with collaborative team meetings and high-stakes client presentations.

The core activities showcased revolve around critical GxP-related projects, demonstrating the consultant’s role in ensuring quality and regulatory readiness. The consultant details spending time on intensive process exercises for a Vault Quality Management System (QMS) project, explicitly stating the work is geared toward preparing the client for external audits. This task underscores the necessity of meticulous process mapping and documentation required to achieve and maintain regulatory compliance, a constant and complex challenge for pharmaceutical and biotech companies. The consultant also highlights the importance of internal alignment, noting regular meetings with the internal "quality team" to ensure project standards are consistently met.

A major focus of the day is dedicated to system validation and client training. The consultant assumes the role of a validation lead for concurrent projects involving Vault QualiDocs and Vault Training. This leadership role culminates in preparing and delivering a detailed presentation via Zoom on User Acceptance Testing (UAT). The presentation covers the practical execution of validation scripts, methods for troubleshooting "snags" encountered during testing, and the formal, compliant procedure for logging deviations. This emphasis on UAT and deviation management is crucial, as these steps are mandatory for ensuring that regulated software systems adhere to predefined specifications and comply with standards such as 21 CFR Part 11. The consultant’s function is thus not merely technical implementation but guiding the client through the rigorous, auditable compliance lifecycle.

Key Takeaways:

• Regulatory Focus in Consulting: Veeva consulting roles are intrinsically tied to GxP and regulatory compliance, with a primary focus on implementing and validating Quality Management Systems (QMS) and related documentation platforms.
• Audit Readiness as a Driver: A core objective of QMS implementation projects is achieving readiness for rigorous external audits, necessitating extensive work on process exercises and documentation mapping to ensure compliance integrity.
• Validation Leadership is Critical: Consultants often serve as validation leads, responsible for directing clients through the complex validation lifecycle, including the critical User Acceptance Testing (UAT) phase.
• UAT Protocol Training: Training clients on UAT execution is a key deliverable, requiring structured demonstrations on how to walk through validation scripts and what steps to take when expected results are not achieved.
• Formal Deviation Management: A crucial element of regulated software validation is the formal process for logging deviations. Consultants must train clients on how to accurately document and log any snags or unexpected results encountered during UAT to maintain a compliant audit trail.
• Veeva Vault Module Integration: The consultant was simultaneously leading validation efforts across multiple integrated Veeva modules (QualiDocs and Training), highlighting the need for expertise in system integration within the Vault platform.
• Internal Quality Alignment: Regular, mandatory meetings with the internal "quality team" are essential for ensuring that project methodologies and deliverables meet the high quality and compliance standards required for life sciences clients.
• Balancing Deep Work and Client Interaction: The consultant's day is characterized by alternating between intensive, focused individual work (e.g., completing eight pages of process exercises) and high-stakes client-facing activities (e.g., leading validation presentations).
• Remote Presentation Best Practices: Utilizing tools like a propped-up iPad for notes and reference during Zoom presentations is a practical strategy for remote consultants leading complex technical and regulatory discussions.
• Value of Peer Support: The Consultant Development Program (CDP) fosters a network of peers who share similar career goals and interests, providing a vital support structure for navigating the challenges of complex, regulated consulting work.

Tools/Resources Mentioned:

• Veeva Vault QMS: The Quality Management System module used for managing quality processes, deviations, CAPA, and audit preparation.
• Veeva Vault QualiDocs: The module used for managing regulated documentation and quality content.
• Veeva Vault Training: The module used for managing compliance training and ensuring personnel are qualified for regulated tasks.
• Zoom: The primary platform used for conducting client meetings and delivering presentations remotely.

Key Concepts:

• Vault QMS Project: A consulting engagement focused on implementing, configuring, and validating Veeva’s Quality Management System to centralize and automate quality processes in a compliant manner.
• Validation Lead: The project role responsible for overseeing the entire validation process, ensuring the system meets regulatory requirements (e.g., GxP, 21 CFR Part 11) and user specifications.
• User Acceptance Testing (UAT): The formal stage of validation where end-users test the system against predefined scripts to confirm it functions correctly and meets their business needs before final release.
• Deviation Logging: The mandatory formal procedure for documenting any unexpected results, errors, or failures encountered during regulated activities like UAT, ensuring a traceable and auditable record of system performance issues.

Examples/Case Studies:

• Audit Preparation Exercise: The consultant dedicated time to completing approximately eight pages of detailed process exercises specifically designed to solidify the QMS implementation and prepare the client for potential external regulatory audits.
• UAT Protocol Demonstration: The consultant led a detailed demonstration for clients on the practical steps required to execute a UAT script, including real-world advice on identifying and managing "snags" and the formal procedure for logging deviations within the system.