Fireside Chat Series: The Relationship Between Content and Technology - Video 1 of 7

This video provides an in-depth exploration of the relationship between content creation and technology solutions (specifically Learning Management Systems, or LMS) within the highly regulated life sciences training sector. Featuring Kent Malmros, Senior Director of Vault Training at Veeva Systems, and Graham O'Keeffe, Founder and CEO of Learnaboutgmp, the discussion centers on whether life sciences companies should source both content and technology from a single vendor or pursue a "best-of-breed" strategy by selecting separate specialist providers for each. The speakers strongly advocate for the latter, arguing that content creation and technology delivery are fundamentally distinct disciplines requiring specialized expertise.

The core thesis presented is that while technology providers like Veeva excel at building robust, compliant software—such as a Part 11 compliant LMS like Vault Training, which integrates with Veeva Docs and ensures efficiency in developing and delivering training—they are not inherently experts in instructional design or regulatory subject matter. Conversely, content providers like Learnaboutgmp focus on deep regulatory subject matter expertise (SMEs), learning strategy, and interactive content development. The speakers emphasize that regulatory training has evolved significantly from the outdated model of annual, room-based refresher training (e.g., GxP annual refreshers) to a demand for continuous, compelling, and regulation-aligned content delivered to the workforce on an ongoing basis.

Graham O'Keeffe details the rigorous process required for effective content creation, which goes far beyond simply converting a PowerPoint deck. His company employs a six-stage process that begins with developing a comprehensive strategy aligned with the customer's specific business needs and processes—not just handing over a generic library of courses. This strategic approach ensures the training aligns with how the business actually functions and addresses specific regulatory requirements and guidelines. The complexity of combining world-class software development (required for the LMS) with world-class regulatory subject matter expertise, learning strategy, and interactive content development (required for the content) highlights why a single vendor often struggles to deliver the "best of the best" in both areas, reinforcing the value of the specialized, dual-vendor approach.

Key Takeaways: • Best-of-Breed Strategy is Preferred: The consensus among the experts is that life sciences companies should adopt a best-of-breed approach, selecting specialized vendors for technology (LMS) and content creation separately, as these are two fundamentally different disciplines. • Technology Focus (LMS): Software providers like Veeva focus on building world-class, compliant platforms (e.g., Veeva Vault Training) that ensure efficiency, effectiveness, and regulatory adherence, including 21 CFR Part 11 compliance, in the delivery and management of training. • Content Focus (e-Learning): Content creation requires specialized competencies, including deep subject matter expertise in regulatory compliance (FDA, EMA guidelines), learning strategy development, and proficiency in interactive content development and instructional design. • Evolution of Training: Regulatory training has moved beyond the traditional, infrequent model (e.g., annual GxP refresher via PowerPoint) to a demand for continuous regulatory information delivery and compelling content that aligns with modern workforce expectations. • Strategic Content Development: Effective content creation is not merely a transactional process; it must begin with a strategic phase. Content vendors should work with customers to develop a strategy that aligns the training courses precisely with the company’s specific business needs and functional processes. • The Conflict of Competencies: It is highly challenging for a single vendor to maintain world-class expertise in both complex software development (required for a compliant LMS) and specialized regulatory content creation, which necessitates distinct teams of developers, SMEs, and learning strategists. • Veeva Integration: Veeva Vault Training is highlighted as a technology solution that integrates with other Veeva products (like Veeva Docs) and is built specifically for the regulatory requirements of the life sciences industry, serving as the compliant delivery mechanism. • Importance of Strategy Alignment: The content creation process must include a rigorous, multi-stage strategy development phase to ensure the training library is tailored to the customer's unique operational environment, rather than relying on a generic, off-the-shelf library.

Tools/Resources Mentioned:

• Veeva Vault Training (LMS)
• Veeva Docs
• 21 CFR Part 11 (Compliance standard)
• GxP (Good Practices regulations)

Key Concepts:

• Best-of-Breed: The strategy of selecting the leading specialist vendor for each component of a solution (e.g., one vendor for the LMS technology and a different vendor for the e-learning content).
• Part 11 Compliance: Refers to 21 CFR Part 11, the FDA regulation governing electronic records and electronic signatures, which is critical for LMS systems used in regulated environments like life sciences.
• Learning Management System (LMS): Software designed to administer, document, track, report, and deliver educational courses or training programs. In life sciences, these must be validated and compliant.
• Regulatory Alignment: The necessity for training content to be continuously updated and aligned with the latest guidelines and regulations issued by bodies like the FDA and EMA.