A Path Towards Improved Training Outcomes and Better GxP Compliance

Ask a learning and development (L&D) leader for their ideal platform for employee education, and the response will likely be a learning system that delivers a seamless experience, improves training outcomes and reduces administrative overhead. These are all essential, but to define a clear learning management strategy and implement the right technology, perhaps start by thinking a little smaller.

When a L&D leader is in the process of developing a new individual training course, several questions typically arise:

• What is the problem we’re trying to solve?
• What do we want to happen as a result of this training?
• What does success look like?

The answers to these questions result in a long list of desired outcomes, and the challenge is prioritizing. Someone must ask, “What is the main thing we need to achieve to ensure focus on a primary objective?” This is familiar ground for anyone developing, delivering and evaluating training content. Still, it is not always the approach taken to create an overall learning management strategy, with the most important challenges and opportunities seen as just individual items in a long list of requirements.

So, what is the main thing a life sciences learning management system (LMS) needs to achieve? Surely, it is important to maintain good practice (GxP) compliance and ensure that anyone performing a regulated activity is qualified to perform that task. Yet, the needs of life sciences human resources (HR) L&D often precede those of GxP. HR is the primary or sole decision-maker for LMS in many of the largest biopharmaceutical companies, frequently leading to adopting an industry-agnostic LMS that cannot meet GxP training compliance standards.

This approach increases risk and complexity, and the numbers reinforce this since over 80% of training at life sciences companies is GxP-related and subject to regulatory oversight. Forward-looking companies should focus on GxP-training programs and technology to drive more efficient, compliant employee training.

Why an Industry-Agnostic LMS is Not Viable for Life Sciences

Using an industry-agnostic LMS to develop and manage training at a biopharmaceutical company will present several shortcomings, including significant third-party dependencies when trying to ensure GxP compliance, increased reliance on manual processes and hidden costs that impact the bottom line. These challenges are not always considered when an HR L&D individual decides, which LMS to bring on board. Biopharmaceutical companies should prioritize three areas during the evaluation processes: validation, integration and customization.

Validation and compliance with Title 21 Code of Regulations Part 11

The core focus of employee education is managing delivery, execution, tracking and reporting within a GxP system. For the system to be GxP ready, it must be validated to ensure that systems generate the outcomes and data as intended. Most industry-agnostic LMS applications do not follow a software development lifecycle with built-in validation concepts. This means that biopharmaceutical companies will need to rely on third parties to produce documentation and manage validation processes, causing delays and increasing the total cost of ownership.

Audit trails are also not traditionally part of industry-agnostic LMS. These are often built afterward, relying on third-party integration for eSignatures to achieve compliance.

Integration

A significant part of learning management is delivering the right content to the right learners at the right time. Content, specifically regarding standard operating procedures (SOPs), policies, digital work instructions and other materials, is managed in a regulated document management system (DMS), and organizations frequently integrate DMS and LMS systems to push new documents for educational programs and trigger reassignments. The process requires significant middleware and validation support, increasing reliance on offline and paper processes to achieve business objectives.

Customization

Many industry-agnostic LMS products rely heavily on customization to achieve business requirements. When those customizations diverge from the standard, shared version of a product, costs can accumulate rapidly. For example, organizations using an industry-agnostic LMS often lack compliance-appropriate training status reports. The data exists within the system to generate training status reports but requires additional manipulation. Integrating with a business intelligence tool could provide the necessary insights but involves customization and extra costs.

Rethinking Content Governance for a More Holistic Approach

A critical yet often overlooked component of learning management is content governance. Learners must be confident that their content is accurate and consistent. This includes ascertaining SOPs, work instructions, eLearning modules and instructor-led training are all aligned and updated when a change occurs.

Many organizations have mastered SOP governance by defining clear owners, controlling versions and performing periodic reviews. However, when learning content is managed in a separate system, ensuring the accuracy of training content and tracking cannot be done with the same robustness and consistency. Taking a unified approach to procedural documents and training is critical to ensuring quality is managed holistically rather than in separate silos within the organization.

Defining a Training Strategy to Meet Requirements

Regulatory compliance education for employees is the foundation for any life sciences enterprise training strategy. An organization could consider the following three fundamental approaches to ensure training aligns with business objectives and regulatory requirements:

• Two-LMS landscape: Adopting a two-system strategy is strongly recommended for large biopharmaceutical companies with a legacy industry-agnostic LMS. HR and quality teams can each build separate governance models that ensure compliance for GxP training and audit readiness while maintaining the desired flexibility for non-GxP training programs. This approach requires multiple integration points, which is true in a single non-GXP LMS scenario and may increase overall costs to ensure GxP compliance.
• GxP-first LMS: Adopting a single GxP LMS could provide a strong employee education foundation for biotech companies looking to drive compliance while retaining speed. It is incumbent to prioritize the critical nature of maintaining regulatory compliance as a fast-growing company. Consider an LMS that delivers baseline Part 11 compliance, seamless audit trails, real-time correct content availability and a mature core LMS functionality feature set. A bonus is that biotech companies can save additional time and costs if the system is pre-validated.
• GxP-first LMS, plus a learning experience platform (LXP): Adopting a GxP-first LMS, companies can use it as the single assignment engine for the entire organization. Adding an LXP that provides social and gamification features in a less rigid environment can help meet the needs of HR L&D while maintaining compliance. With this approach, companies can deliver a unified learner experience and maintain a master record for assignments.

Conclusion: Prioritizing GxP Training for Audit Readiness

Most life sciences companies develop an education strategy focused on the needs of HR L&D, and the implications are weighing heavily on the industry. With higher costs, fragile integrations, more manual work and significant risks, leading biopharmaceutical companies are rethinking this approach to transform employee education.

Adopting a training strategy that aligns life sciences and business requirements, like a two-LMS landscape approach for large biopharmaceutical companies, can provide a competitive advantage by significantly simplifying the technology landscape while driving employee qualifications and compliance. This frees up time and resources for focusing on high-value activities that can improve efficiency and effectiveness.

With nearly 80% of training requirements supporting GxP compliance, a GxP-first approach focused on quality could significantly improve operations, simplify training and build a quality culture. Balancing HR and GxP requirements and homing in on business priorities can help define the best approach to drive compliance while remaining nimble. First and foremost, companies need employees to be properly trained to execute processes to develop, manufacture and distribute the medicines that patients need.