Role-Based Training: Compliance & Qualification

By January 31, 2019October 12th, 2021LTEN Focus On Training


Role-Based Training: Compliance & Qualification

Feature Story – By Kent Malmros

Corporate training professionals have been implementing role-based training concepts for decades, yet they continue to struggle with assigning the right amount of training content without incurring compliance risk. Modernized role-based training ensures the right content, reaches the right people, at the right time.

Learner roles do not always equate to a single job title, and should be based on a combination of job responsibility, function or other attributes such as job code or ID. However, delivery approaches using legacy learning technologies typically require learner roles to be the same as the job title. When 500 employees are defined by 500 unique learner roles, it is impossible to build a scalable training program that always delivers appropriate, contextual content. Trainers are forced to place individual learners into one or more groups – aligned within departments, business units or functions. With this model it’s easy to over-train employees and partners while ensuring there are no compliance gaps. With modernized role-based training, learning objectives and corresponding training materials are aligned to the specific needs of an employee, partner or contractor.

For life sciences companies, role-based delivery is essential for efficient and effective training programs. It is important in commercial or leadership development training and mission critical for noncommercial areas such as quality, compliance, GxP and manufacturing.  Limitations of legacy learning technologies prevent precise delivery of well-engineered content to specific learner roles, contributing to the following training-related challenges:

  • Limited Visibility into Overdue or Incomplete Assignments: When learners don’t complete their training, they may not be qualified to do their jobs or capable of completing critical functions that is compliant with agency guidelines or regulations. Tracking and providing transparency on overdue or incomplete training allows all levels of the organization to gain visibility and mitigate risks.
  • Lack of Content Mastery: Even with the perfect curriculum design – targeted to the right learner population, appropriately delivered and tracked – companies need to demonstrate content mastery. Adding assessments or observations around critical procedures can substantiate comprehensive
    knowledge and training.
  • Training Gaps: There are several reasons that content-based gaps can occur – ranging from budget constraints to minimally qualified subject matter experts. Some training gaps have a compliance impact, others have functional repercussions. Easily identifying the right content to train the right roles eliminates compliance-related knowledge gaps.
  • Over-Training: To avoid learning gaps, many organizations over-train their employees. With the limitations of many learning delivery platforms, it’s often easier to deliver more content to learners than manually configure focused curricula. Leveraging a training matrix that aligns learning objectives to roles, organizations can ensure learners consume, master and retain the right amount of information.

With a modern training solution, organizations can ensure the right content, reaches the right people, to do the right job, at the right time – even in a highly matrixed organization. To deliver maximum role-based compliance, consider the following capabilities in modern training solutions:

  • Learner Role Visibility: It is essential that users are part of the right groups – learner roles and getting the right assignments. With visibility into learners and the groups users belong to, organizations can see that key operating procedures, policies and work instructions are reaching the right audiences. This ensures compliance in day-to-day job functions.
  • Role-Based Automation: Automating assignments based on qualifications and job readiness helps learners stay up-to-date on training – even as they change roles responsibilities or location For example if manufacturing plant employees change roles and need to operate a different piece of equipment, or a training administrator adds a new learner role to an employee, new training tasks should automatically be assigned. Technologies that leverage a role-based approach to training configuration can automate assignments based on change in attributes. Ensuring learners read critical operating procedures and there is traceability of job qualification status reduces compliance risk and improves quality outcomes.
  • Unification: Allowing business critical applications to automatically trigger training tasks can accelerate quality processes and improve training outcomes. For example, corrective and preventive actions (CAPAs) frequently have a training impact. Identifying who should be trained is a manual process.  Training materials that are organized by learner roles should be discoverable, flaggable, and associated with quality events or other business critical processes.

People are coping with information overload, and overtraining makes it difficult to focus only on content that will meet learning objectives. With appropriate role-based training, companies can automatically identify and deliver training based on a combination of attributes such as manufacturing site, department, and function.

Highly targeted training enables the right amount of information delivered to the right person, at the right time, to complete their job compliantly. As companies transition to modern learning frameworks, such as micro-learning, it is critical to find learning technology that is flexible and support role-based training.

Kent Malmros is senior director, Vault Training, for Veeva Systems. Email Kent at


About LTEN

The Life Sciences Trainers & Educators Network ( is the only global 501(c)(3) nonprofit organization specializing in meeting the needs of life sciences learning professionals. LTEN shares the knowledge of industry leaders, provides insight into new technologies, offers innovative solutions and communities of practice that grow careers and organizational capabilities. Founded in 1971, LTEN has grown to more than 3,200 individual members who work in pharmaceutical, biotech, medical device and diagnostic companies, and industry partners who support the life sciences training departments.

Leave a Reply