Vault Submissions Publishing eLearning Demo

This video provides an in-depth demonstration of Veeva's "Vault Submissions Publishing e-learning" offering, a specialized training program designed to facilitate the transition of regulatory operations teams from legacy publishing systems to the integrated workflow of Veeva Vault Submissions Publishing. The core message is that Vault fundamentally changes the regulatory submission process by moving traditional publishing tasks earlier in the submission life cycle and eliminating others, thereby requiring a dedicated, structured training approach to onboard and educate users effectively. The training is self-paced, online, and continuously maintained by Veeva publishing experts to ensure alignment with the latest features and industry best practices.

The e-learning curriculum is strategically divided into three key components. First, the Initial Onboarding provides foundational training covering the essential steps required to manage a regulatory application from its initiation through the final submission of published content directly to the health authority. Second, Differences Training is release-based, offering deep dives into new features and updates rolled out with each Veeva release, ensuring users stay current. Third, the Advanced Topics Library serves as a repository of micro-learnings focused on specific, complex use cases or regional regulatory considerations, such as non-USB submissions, which are slated for future development. The content delivery is flexible, accessible either via a dedicated Veeva-hosted training environment called "e-learning direct" or directly integrated into a client's existing Veeva Quality Vault.

The course structure is designed to first bridge the knowledge gap for experienced publishers. It begins with a comprehensive Vault RIM overview section, which explicitly maps traditional publishing steps to the new Vault submissions publishing process, highlighting how key processes are changing. This foundational understanding is followed by detailed, smaller lessons focusing on specific process steps. The curriculum progresses logically, starting with the creation of applications—emphasizing how the initial details entered impact the entire downstream submission—and moving through submissions, content plan creation, and critical publishing activities such as validation, hyperlinking, finalizing content, and submitting to the health authority.

To maximize user engagement and practical skill development, the training utilizes a variety of interactive modalities. These include text-based training supported by visual aids and screenshots, interactive graphics that require users to click and engage to reveal detailed information, and brief demos. Most critically, the program incorporates software simulations, which are hands-on exercises requiring users to complete the actual steps needed within a simulated Vault RIM environment. This simulation feature allows users to gain practical, muscle-memory experience. Learning is reinforced through knowledge checks, including quizzes at the end of each major process section and a final comprehensive knowledge check summarizing the key lessons presented throughout the entire course.

Key Takeaways:

• Process Transformation Focus: Veeva Vault Submissions Publishing fundamentally alters the regulatory submission workflow by shifting publishing tasks earlier in the lifecycle and eliminating traditional steps, necessitating specialized training for existing regulatory operations teams.
• Structured Training Components: The e-learning program is segmented into Initial Onboarding (basics from application initiation to submission), Differences Training (release-based updates), and an Advanced Topics Library (micro-learnings for specific use cases and regional considerations).
• Bridging Legacy Knowledge: The course begins with a crucial Vault RIM overview designed to map traditional publishing steps to the new Vault process, helping experienced publishers understand the specific operational differences they will encounter.
• Importance of Application Details: The training emphasizes the critical nature of the initial application creation process, detailing how the information entered at this stage directly impacts the overall downstream submission activities and requirements.
• Hands-On Simulation: A key feature is the inclusion of software simulations, which are interactive demos requiring users to perform the actual steps needed to complete processes within a simulated Vault RIM environment, providing essential hands-on experience.
• Continuous Content Maintenance: The training content is actively maintained and regularly updated by Veeva publishing experts, ensuring that users are always trained on the latest features, regulatory best practices, and system changes.
• Modular Learning Design: Lessons are broken down into smaller, manageable modules covering specific process steps (e.g., submissions, content plan, validation, hyperlinking, finalizing content), allowing users to track progress easily and focus on specific areas.
• Reinforcement through Knowledge Checks: Learning retention is enforced through quizzes at the end of each major process section and a final comprehensive knowledge check at the conclusion of the course.
• Flexible Access Models: Companies can access the training content either through the Veeva-hosted "e-learning direct" platform or by having the content delivered to their existing Veeva Quality Vault, offering deployment flexibility.
• Regulatory Scope: The current course primarily focuses on the key processes of a USB (United States) submission, with plans to expand the advanced topics library to include other critical regional regulatory considerations in the future.

Tools/Resources Mentioned:

• Veeva Vault Submissions Publishing
• Veeva Vault RIM (Regulatory Information Management)
• Veeva Quality Vault
• e-learning direct (Veeva-hosted training Vault)

Key Concepts:

• Vault Submissions Publishing: A modern system for managing the creation, validation, and submission of regulatory documents to health authorities, characterized by integrating publishing tasks earlier in the submission lifecycle.
• Differences Training: Release-based training modules focused on educating users about new features and changes introduced in specific software updates, crucial for maintaining proficiency in evolving regulated software environments.
• Software Simulation: An interactive training method that replicates the actual software environment, requiring the user to execute the necessary steps to complete a task, thereby providing practical, risk-free experience.
• Hyperlinking and Validation: Core publishing activities covered in the training, ensuring that submission documents meet technical standards and link requirements before final submission to the health authority.
• Vault RIM Overview: A foundational section of the training designed to provide context on where publishing sits within the broader Regulatory Information Management platform and how traditional workflows map to the new system.