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The case for a single enterprise-wide learning management system
Pharmaceutical companies are all trying to advance the health
and well-being of people through their products and services in a way that creates profitable and sustained growth for their organization. However, as these organizations grow and work to achieve these goals, they are faced with ever-increasing layers of complexity within their business. This is especially true with the introduction of new products, technologies, facility expansions, emergence into new markets, and the management of mergers and acquisitions.
Added to this complexity is the challenge of investing in enterprise-wide applications that support an expanding manufacturing process and value chain, as well as a myriad of other issues. This progression creates a diverse set of needs for their employees, suppliers, clinicians, third parties and even customers. These needs include compliance, development and performance across the company.
Companies could greatly benefit from the implementation of a single enterprise-wide earning management system. Unfortunately, what happens more often than not is that each department acquires and implements their own learning management system (LMS), due to the nature of their specific needs and challenges. At that point, the objective to minimize complexity and enhance the success of positive change and growth is handicapped due to disparate LMS programs across the organization. Problems arise with the lack of a cohesive solution in place, including the right mix of technology and knowledge to move people and processes from the current state to a high performing future state.
Determining the reason why a multitude of systems end up in an organization can, at a glance, appear simple. The growing and evolving departments have distinct learning and development goals, and finding a single platform that can be customized to meet these diverse goals has been a challenge.
Departmental goals may include:
Given these very diverse yet mission-critical learning and development goals, the result is various departments acquire their own LMS that they may perceive to be helpful in the short term, but actually adds another layer of complexity that will make solving the real challenge all the more difficult. Having numerous, non-integrated, learning and development technologies in-house is actually symptomatic, in that it exposes the lack of a holistic enterprise-wide strategy for learning development.
This strategy will align not only with the overall learning and development goals, but also with the specific environment, people, processes and process-enabling technologies within the organization. Just as critical, the technology must be sufficiently advanced to adapt to the specific needs of each department.
Solving the GxP qualification challenge
A significant challenge with pharmaceutical companies often lies with the strict data integrity requirements of US and EU regulations. Companies are required to ensure that anyone involved in the design and production of the products is qualified for their role. In addition, regulatory agencies globally require that the workforce be educated on GxP concepts, as well as SOPs and work instructions based on their specific role in the organization.
Addressing this need is typically outside of the HR auspices and falls under Quality Assurance. It demands an LMS that supports the following five regulatory requirements around GxP training and qualification:
Balancing training programs companywide
FDA has some clear expectations for training. For instance, they require that each employee receives the appropriate education, training and experience (21 CFR 211.25) in the operations the person performs. In order to ensure this is happening, the company should establish procedures for identifying training needs and assuring all personnel are adequately trained to perform responsibilities. The responsibility is not only on the shoulders of the learners, however. The trainers should be qualified. One of the fundamental elements of a training program is that the training not be a once-and-done event, it should be conducted on a continuing basis to ensure employees remained trained and are up to speed on new or revised regulations and procedures. Furthermore, all of this needs to be documented in an air-tight, audit-proof format. That is where a single-enterprise LMS shows its true value. This way, all departments can use one system, regardless of whether they are required to follow the higher-level regulatory requirements or the company’s own guidelines.
To ensure technology adoption and requirements are properly met, companies should have a strategic road-mapping plan in place, establish a governance system, and have a departmental development goal-setting initiative. These will help ensure technology adoption and requirements are met properly across the board. HR will develop goals to measure performance and provide career advancement opportunities to ensure employee retention and employee engagement. At the same time, their goals will capture the department’s need to provide and measure “technical skills,” and to improve an individual’s competency ratings. Quality Assurance will need to track a role-based qualification matrix, as these records are scrutinized by FDA and other global regulatory bodies during inspections.
The enterprise-wide learning system should provide an adaptive user experience that supports “universal” competency programs and performance management programs that HR can deliver to employees.
Such a solution provides many benefits:
Timely analysis of the curriculum that is customized by department and realigned when necessary will help ensure that proper training is being given to the right people at the right time.
Perhaps the most important benefit from an enterprise-wide learning system and balanced training system is that managers can conveniently share data across the enterprise, especially in areas of career development and compliance status. What this does is provide decisionmakers with better data and greater insights—within a unified and cohesive system environment. With a single solution, leaders can visualize relationships and patterns between operational and business activities in new and extremely valuable ways. Companies will more effectively see connections to problems and solutions as they are unfolding. In highly regulated business environments, finding these correlations, the single appropriate enterprise-wide learning plan and the ideal LMS solution is more important than ever.
ABOUT THE AUTHOR
Isabelle Noblanc is vice president and general manager of UL Compliance to Performance.