Fireside Chat Series: Knowing When to License Content Libraries - Video 2 of 7

This fireside chat, featuring Kent Malmros of Veeva Systems and Graham O'Keeffe of Learnaboutgmp, explores the critical strategic decision facing emerging life sciences companies: determining the optimal time to license external GxP-focused e-learning content libraries. The discussion is framed around the relationship between e-learning technology, specifically Veeva Vault Training, and specialized content, emphasizing the need for companies to first establish a robust, compliant technology foundation before attempting to scale their educational offerings through licensed content. The core thesis is that while internal teams must manage the "nitty-gritty" of controlled document training (SOPs), the moment training demands exceed the internal department's capacity or expertise, external content licensing becomes necessary.

The speakers detail the significant operational burden placed on internal training departments in rapidly scaling life sciences companies. Initially, these departments are overwhelmed by day-to-day activities such as managing SOP updates and ensuring compliance with controlled document training, often relying on a 21 CFR Part 11 compliant Quality GxP-oriented Learning Management System (LMS) like Veeva Vault Training. However, when new, broad regulatory topics emerge—such as data integrity awareness—the internal team lacks the specialized skill set to develop compelling, compliant training content. This process requires identifying subject matter experts (SMEs), who are already busy with their primary duties, and then managing a complex project involving instructional designers, voiceover artists, and wireframing specialists, making internal library creation impractical and slow.

A key distinction is drawn between the function of the LMS and the function of the content library. Veeva Vault Training is positioned at the "SOP layer," handling the technical, document-centric training specific to the company’s internal processes. The external content library, conversely, provides the essential "educational layer" above that. Graham O'Keeffe provided a compelling example of a company training new hires on a 36-page CAPA (Corrective and Preventive Action) SOP, only to realize the employees didn't even know what CAPA stood for. The foundational educational content—understanding the basics of CAPA—must precede the technical training on the company’s specific SOP, illustrating where licensed, specialized content becomes indispensable for ensuring true comprehension and compliance.

The strategic advice provided is clear: the right time to license a content library is when the required areas of expertise exceed the internal team's purview. Companies should focus on making their core technology (the LMS) as efficient and compliant as possible for managing controlled documents first. Once that foundation is solid, they should seek an extended ecosystem of partners who can execute the complex content development steps with excellence, rather than sacrificing quality or compliance by choosing a single vendor offering both technology and a broad, potentially non-specific, content library.

Key Takeaways: • Prioritize Technology Compliance First: Emerging life sciences companies must first solidify their ability to deliver qualification sets around controlled documents using a 21 CFR Part 11 compliant, GxP-oriented LMS (like Veeva Vault Training) to ensure audit readiness and regulatory adherence. • The Tipping Point for Licensing: The correct time to license an external content library is when the required areas of expertise for training development exceed the capacity or skill set of the internal training department. • Internal Content Creation is Costly and Slow: Developing comprehensive GxP training internally is highly inefficient, requiring significant project management, instructional design, SME identification, and regulatory alignment, often diverting resources from core operational tasks. • Distinction Between Layers: The LMS handles the "SOP layer" (nitty-gritty, technical, company-specific document training), while licensed content libraries provide the necessary "educational layer" (foundational knowledge, regulatory awareness, and broad concepts like data integrity). • Foundational Knowledge Gap: Training on technical SOPs (e.g., a 36-page CAPA process) is ineffective if employees, especially new hires or those crossing over from other industries, lack the foundational understanding of the underlying concept (e.g., what CAPA is). • The Risk of Sacrificing Quality for Convenience: Organizations often look for a single vendor providing both technology and content for convenience, but this risks sacrificing the quality of both the document-centric training delivery system and the specialized regulatory content. • Focus on Specific Quality Needs: When licensing content, companies must ensure the library specifically meets their quality and regulatory needs, avoiding broad libraries that may not align with strict GxP requirements. • Strategic Partnership Model: Companies should view content providers as strategic partners who can execute the complex steps of content development (SME engagement, instructional design, regulatory alignment) with excellence, complementing the internal technology platform. • GxP and Regulatory Focus: The primary and most critical initial area of training need for emerging life sciences companies is always GxP-related controlled document training, which must be managed through compliant systems.

Tools/Resources Mentioned:

• Veeva Vault Training (LMS/e-learning technology)
• Learnaboutgmp (Premier e-learning content provider in life sciences)

Key Concepts:

• 21 CFR Part 11 Compliance: Regulatory standard for electronic records and electronic signatures, critical for compliant LMS systems in the life sciences.
• GxP (Good Practices): A collection of quality guidelines and regulations ensuring products are consistently produced and controlled according to quality standards (e.g., GMP, GCP).
• Controlled Document Training: Training specifically related to company Standard Operating Procedures (SOPs) and other regulatory documents, typically managed within a validated LMS.
• CAPA (Corrective and Preventive Action): A system for improving organizational processes and preventing recurrence of non-conformances.
• Data Integrity Awareness: Training focused on ensuring the accuracy, completeness, and consistency of data throughout its lifecycle, a critical regulatory requirement.

Examples/Case Studies:

• CAPA Training Failure: A company trained new hires on a 36-page CAPA SOP but failed because the employees lacked the basic background knowledge of what CAPA was, necessitating the use of foundational educational courses before technical SOP training.