The Value of an LMS
In the past few years within the industry, there has been a whisper and now, seemingly, a full-throated shout about the LMS being dead. There have been a number of articles as well as conference presentations circulating around industry claiming that the modern day LMS is no longer useful—it’s dead and should be buried. For example, there is a conference presentation at LTEN called “The LMS is Dead” and articles such as “The LMS Market is Quickly Losing Ground”.
But, to poorly paraphrase Mark Twain’s alleged quip, “The reports of the death of the LMS are greatly exaggerated.” While there is certainly a push into different ways of delivering instruction, within the compliance industry, the need and purpose for an LMS has not abated. Additionally with increasing regulatory and consumer demands, it is quite reasonable to assume that the LMS does not need to worry about it’s so call “impending doom.”
Yes, the LMS industry and systems will continue to change and morph over time based on industry demands and technological innovations but the need to track, regulate and verify training content remains a key part of organizations in the pharmaceutical, medical device and environmental health and safety industry.
A LMS is simply a Learning Management System. It is an electronic system designed specifically for distributing learning content and for tracking how that content is consumed. The content can be as simple as a PDF file or as complicated as a full-fledged learning simulation and everything digital in between such as e-Learning courses, video and audio files. In other words, any digitally available content can be housed, distributed and tracked with a modern-day LMS.
But to understand why an LMS is so critical in an FDA regulated industry, let’s look at some key functionality of the modern day LMS and how the LMS contributes to increasing efficiency in meeting FDA requirements.
A key component to consider in the life science industry is the effort surrounding compliance with 21 CFR Part 11. In short, Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. Part 11 also applies to electronic records submitted to the FDA under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act.
This type of tracking for training and documentation can be a time consuming and difficult process if the electronic records are kept in different systems by different departments or kept in a file on a file server by a manager who records information when he or she has time. Yes, this data can be tracked on a spreadsheet at a small scale, but any growth or expansion makes tracking with a spreadsheet a nightmare or tracking of training in different systems a potential auditing red flag.
With a LMS in place, organizations can track who logs in, when they logged in, what version of training they received and how they performed on the overall training and on individual question all with little to no intervention by a manager. Additionally, a system administrator can pull out the information behind the scenes without needed to talk to the manager or track the manager down to get the spreadsheet. The LMS enables a quick and painless process to ensure validation and met requirements for audit trails, record retention, and record copying in the manner described in the guidance from the FDA.
Keep in mind that the LMS provides documented, verified information in one location ensuring document control as well as allowing a proper level of access. The FDA, under Part 11 enforces provisions related to the following controls and requirements:
- limiting system access to authorized individuals
- use of operational system checks
- use of authority checks
- use of device checks
- determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks
- establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures
- appropriate controls over systems documentation
- controls for open systems corresponding to controls for closed systems bulleted above (§ 11.30)
- requirements related to electronic signatures (e.g., §§ 11.50, 11.70, 11.100, 11.200, and 11.300)
The FDA expects compliance with these provisions, and the FDA enforces those requirements. In addition to providing training and helping with validation of training materials, modern-day LMS’s enable companies to manage the distribution of SOPs, corporate policies, forms, surveys and routine communications with documented electronic receipt and tracking to employees, suppliers and contractors. The tools available in an LMS greatly contribute to efficiencies and productivity in the area of compliance.
While compliance is a key functionality and requirement keeping the LMS alive, that’s not the only value of the LMS. A properly implemented and deployed LMS can improve organizational productivity and provide a competitive advantage in many areas—especially in the area of talent development.
Value it an organization is added through the identification, training and retention of talent and this is where a LMS can added a great deal of value. The LMS can give you insights into the skills and competencies of employees, as well as, provide employees with visible pathways to obtaining more skills and promotions. Managers can quickly determine who has the right skills to fill-in for another employee and who needs more training to add more value to the organization.
A modern-day LMS provides features such as side-by-side comparison of talent, succession planning models and individual employee profiles for identifying and tracking high potential workers.
The impact of an LMS on organizational culture, compliance and employee talent identification and retention cannot be overlooked. While it’s popular to bash the LMS, the modern-day version of a LMS provides a tremendous value to an organization and is a cornerstone of organizations that want to both comply with FDA regulations and create a competitive advantage through the development and growth of their employees.
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