Risk-Based, Audit-Ready Training Supports Madrigal’s Commitment to Quality

Madrigal, a mid-size biopharma company, wanted to replace its existing training platform and introduce a more modern and engaging eLearning library. Since implementing Veeva Training in 2023, the company has approached risk management strategically to speed adoption of the Quality Vault and its use of Veeva Training and LearnGxP.

Imagining a different course

Dissatisfied with its legacy learning management system (LMS), Madrigal sought to unify its regulatory-compliance training platform and eLearning library into a single, comprehensive solution. “Our legacy LMS wasn’t scalable or intuitive enough to meet the evolving compliance expectations of a growing biopharmaceutical company,” explains a member of the Madrigal quality assurance team. “We needed a system that could seamlessly integrate SOP-based training with dynamic regulatory content, enabling better traceability and learner engagement within one quality system.”

The quality assurance team wanted to integrate Madrigal’s required process-based SOP document training with supplemental regulatory and compliance training. By adopting a single platform encompassing Veeva QualityDocs, QMS, Training, LearnGxP, and (in the future) Batch Release, it aimed to improve data integrity, enhance collaboration, and reduce the administrative burden.

As the goal was to simplify and improve compliance, having all training records (SOP-driven and regulatory refresher) in one validated LMS makes it easier to produce a complete, audit-ready training transcript. Being able to show training compliance across roles and departments also enhances inspection readiness. Implementing Veeva Training has conferred several benefits:

• Native integration with QualityDocs and QMS: Unlike the previous LMS, which required manual uploads or batch jobs, Veeva Training allows Madrigal to assign training directly from controlled documents with version-aware tracking. This eliminates redundancy and ensures real-time alignment between training and SOP revisions.
• Centralized compliance dashboard: This provides a real-time view of training compliance across departments. Having relied on exports and manual reports with the previous LMS, the team now uses Veeva’s unified dashboard for proactive monitoring and faster internal follow-ups, supporting inspection readiness.
• Automated, version-controlled SOP training: Being able to link SOPs directly to training requirements was a big win for the quality assurance team. When a new revision is released, the system automatically assigns it, tracks completions, and retires the outdated version without manual intervention. This ensures employees are always trained on the most current procedures, improving compliance and reducing the administrative burden.

Bridging the ‘what’ and the ‘why’

As implementation of Veeva Training neared completion, the Madrigal team added the LearnGxP library to rightsize GxP refresher training. While SOPs show the task, LearnGxP content explains the ‘why’, promoting true compliance because learners understand the context.

• Unified GxP and non-GxP training experience: Leveraging the easily configurable functionality of the Veeva Vault Platform, the team has successfully segregated views and permissions for its GxP and non-GxP training, while managing both within the same platform. The user experience has improved and system administration is simpler, all within the correct compliance boundaries.
• Full and engaging content library: Adding the full LearnGxP library to the existing Veeva Training platform allowed Madrigal to assign story-based content to learners, and track completions, within one validated and compliant quality system. Engaging microlearning videos are a step up from traditional compliance eLearning. “Employees asked for more modern, story-driven content. LearnGxP delivered on that need with fresher formats that actually resonate with our teams,” says the quality assurance team member.

From static assignments to risk-based training

Madrigal can now offer a streamlined experience for both learners and those assigning training. Realized benefits include:

• Story and scenario-based training: Each course presents a real-world story or theme (and related scenarios) to engage learners and help them retain key information.
• Seamless audit trail for training lifecycle: Enhanced inspection readiness through a defensible, end-to-end training audit trail within a validated system.
• Simplified assignment of role-based training: Reduces effort of manual assignment, ensuring correct training delivery during reorganizations or expansions.
• Staying the course: Courses are assigned with compliance risks and business objectives in mind, supporting continued expansion of the LearnGxP community.

Compliance as a culture driver

By integrating LearnGxP into the Veeva Training ecosystem, the quality assurance team at Madrigal has shifted the perception of compliance training from a routine task to an opportunity for growth. “Modern, scenario-based content promotes a deeper team understanding where quality and compliance are shared responsibilities, not just checkboxes to complete. It’s helped embed compliance into the team mindset, not just their calendars,” concludes the quality assurance team member.

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