Reconciling Regulated and Nonregulated Training

Regulated training is required of most if not all health care organizations. Aligning this training with an organization’s nonregulated training needs can greatly benefit productivity and the bottom line.

Life sciences companies operate under a dual pressure: to be agile, cost-effective and fast moving while also maintaining the highest standards of quality and compliance. In principle, the systems and processes that ensure compliance and confer control can also be those that promote performance by giving people the information they need, when and where they need it. In practice, however, the systems and processes built to ensure compliance and quality have often been more effective at maintaining and demonstrating control than supporting performance. Often, these systems are perceived as cumbersome, particularly by employees whose experience falls outside core compliance functions such as quality assurance and regulatory affairs. This is one reason that, in most life sciences companies, two worlds of information management have been established — the regulated and the nonregulated — with dual processes and systems being developed for common functions like document management and training administration.

On balance, the “two worlds” approach has worked for companies. It has allowed them to deploy the systems and processes needed to maintain compliance and control while shielding nonregulated functions from the perceived burden of such systems. Of course, redundancy is expensive and contributes to business complexity. It also shields systems from some of the selective pressures that ought to drive their evolution. As a consequence, systems in the regulated world are often less user-friendly than they should be, and systems in the nonregulated world often contain information that is out of date or of otherwise questionable value.

Millennium: The Takeda Oncology Co. wanted to see if it could bridge the gap between the regulated and nonregulated worlds, at least with respect to training. It did so by establishing a single, common process for training administration and a single, validated learning management system (LMS) for use by all.

A Starting Point
To develop its employees and ensure that they are qualified for their work, Millennium maintains an extensive training program. It trains on laboratory, clinical and manufacturing best practices as well as on the operation of its overall quality system. It also trains employees on corporate values and policies and on a broad range of topics related to products and internal processes. Its learning and development function offers a catalog of courses focused on employee professional development.

Until 2007, training at Millennium was divided into regulated and nonregulated training — each with its own processes for assigning, delivering and tracking employee training. In the regulated world, a hybrid paper-and-electronic system was used by the quality assurance function to administer compliance-related training. In the nonregulated world, a spreadsheet-based process was used by human resources to administer policy training and professional development. As the company grew, so did the volume of employee training and the challenge of managing training in a compliant and efficient manner. These factors led Millennium to invest in a learning management system.

Millennium set a goal to deliver a single LMS to serve the entire enterprise, both regulated and nonregulated. This required a system that was validated per Title 21 CFR Part 11 of the Code of Federal Regulations, which deals with the Food and Drug Administration guidelines on electronic records and electronic signatures, defining the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. It also required a system that was maintained in a state of control as the authoritative source of its training records, as well as being easy to use and containing a process that shielded employees in nonregulated areas from unnecessary “red tape.”

Millennium sought also to deliver a pragmatic solution and value for the money it was spending, and this meant minimal software customization, sparing the use of outside consultants and no incremental head count to support the system. From the time the project charter was finalized, it set a goal to complete initial implementation of the system within a year.

Start with process, not technology. When planning for the implementation of a new business system, it is tempting to jump right into software selection. This poses particular risks when bridging the regulated-nonregulated divide, however, as stakeholder groups will have very different ideas of what they need from a system. Millennium started by developing a consensus model of how training administration should work, without reference to software features or functions. Millennium then asked which steps in its process needed to be automated and in this way derived system requirements. Requirements definition was followed by a disciplined request for proposal and the vendor selection process. By the time Millennium sat down with vendors, its cross-functional team was in full agreement on what it was looking for in an LMS.

Develop a simple conceptual model and explain it relentlessly. Most companies strive to design processes that are as simple as possible, but complexity happens. How do organizations convey an understanding of such processes to employees without baffling them or, more likely, getting tuned out entirely? There are no easy answers here, but a useful approach is to distill information into a story or make an analogy to something familiar. Millennium used a simple supply-and-demand analogy to explain the key roles and activities in its new learning management process and worked hard to ensure that this analogy was carried through all project communications in a consistent manner. Through sheer repetition — and the natural power of a conceptual model to elicit attention and aid memory — it was able to build a basic understanding of the new process among its employees without inundating them with detail.

Manage the project scope. This is a truism in project management, but in the case of LMS implementation it assumes particular importance. An LMS may integrate with or depend upon a company’s human resources information system (HRIS) system, its controlled-document repository, its competency models or job classifications and its corporate portal — to name just a few. Not all of these will be ideally suited to the LMS, and there can be pressure to expand the scope of the LMS project to improve the fit with these related systems. Again, there are no set answers, but thorough consideration of risks and benefits can lead the team to make the right trade-offs. Millennium decided to integrate its LMS with its HRIS and its document control system because these integrations were relatively straightforward and because they afforded improved control over its training process and records. It decided against modifying its standard operating procedure (SOP) typology to better suit training administration, deciding instead to map the existing typology to a set of database domains within the LMS.

Establish strong project governance. A cross-functional, executive-level steering committee is essential to the success of an enterprise LMS project. A steering committee provides the remit and resources needed to launch the project and the ongoing, vocal support needed to sustain it through completion. Just as importantly, it serves as the forum for deciding a host of questions that the project team itself cannot: Which department will own the LMS? Will administrative responsibility for the system be centralized with the owning department, or will it be distributed among others? How will mandatory training be assigned to employees, and who will have the authority to assign it? Who will be accountable for the provision of training? How will enterprise training performance be measured and reported? An effective project team will frame these issues for the steering committee, define options and make recommendations, but it is the steering committee members themselves who are in the best position to make the right decisions — and to make them stick.

The Result
Millennium today has a single, compliant LMS in use by the entire company. It is the centerpiece of a new enterprise process with defined roles, documented procedures, tracking metrics and governance. The system was delivered in approximately 18 months, within budget and with no incremental head count. Within two months of the system going live, the companywide training completion rate reached 95 percent and it has held there, or above, in each of the succeeding 13 months. Despite the expected learning curve associated with the use of a new system, employee response to the LMS has been positive.

Of course, nothing is perfect. Although Millennium’s LMS is relatively simple for end users, its complexity for system administrators is considerably greater. As a consequence, Millennium’s LMS central team has had to devote more time than anticipated to training and supporting local LMS administrators in the various business areas. Because local administrators may only perform LMS tasks occasionally, their opportunity to truly cement these skills is limited, and Millennium may be faced with a choice of either continuing to provide a high level of support or else consolidating more administrator work within the central team.

Millennium has found that it is possible to bridge the regulated and nonregulated worlds with a single enterprise LMS. The burden on nonregulated employees is manageable, and control of the system is not compromised. Benefits of this approach include simplicity for employees, a single version of the truth regarding training programs and compliance and reduced cost of ownership when compared to dual systems. Millennium’s LMS is one step toward what it hopes will be continuing progress in reconciling its commitment to quality and compliance with a parsimonious approach to systems development and a focus on simplifying work for its employees.