Life science companies operate in high consequence industries with regulatory bodies like the U.S. Food and Drug Administration (FDA) mandating stringent employee training and compliance requirements. Therefore, it’s of the utmost importance that life science companies choose a learning management system technology solution that not only meets stringent regulatory requirements but that also supports a culture of compliance for their organizations. Learning management systems offer an abundance of features and functionality, but there are several key features that life science companies require to deliver an effective compliance training solution.
- Electronic Signature
A life science LMS must support electronic signatures. The FDA requires that life science companies execute and document employee training. These requirements ensure that employees understand how to perform their duties within their company and industry guidelines. When employee training is provided online, an electronic signature is required as documented proof that the training has taken place. 21 CFR Part 11 is the part of the Code of Federal Regulations that establishes the FDA’s regulations on electronic records and electronic signatures. It essentially defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
- Versioning Support
Life science companies operate in an ever-changing environment that requires constant updates to policies, standard operating procedures and work instructions. Training needs to be assigned to the most current version of these materials. A life science LMS should support version control of training materials and ease of updating training curriculum or learning paths for newly versioned training assignments. Additionally, all historical versions of training materials must be stored and easily retrievable.
- Role-based Training Assignments
Training requirements and certifications vary according to an employee’s role within the organization; therefore, it’s essential that the life science LMS easily assign job-specific training programs based on a user’s role, job title, group, or similar delineation.
- Automated Reminder Notifications
It’s challenging staying abreast of employee training enrollments and completions. An LMS that delivers automated email notification reminders can alert employees of their training status to help ensure successful training completions.
- Audit Trails
An audit trail is used to keep track of administrative actions performed in the learning management system. Audit trails must be readily available upon request and provide a comprehensive record of transactions in the LMS that includes the date, time, and user information for the employee that modified the record. Furthermore, audit trails need to be automatically generated when records are changed while remaining secure and un-editable.
In order to maintain compliance, life science companies must ensure that their employees have the education, training, and experience, to perform their assigned duties, and they must be able to provide evidence of it. The right LMS helps alleviate the administrative burdens associated with delivering a robust compliance training program and helps to minimize your company’s risk of noncompliance. If you’d like to learn more about how ePath Learning supports companies in the life science industry, contact us today.
Susan Distasio | eLearning Industry Crusader | ePath Learning, Inc.
About the Author: Susan Distasio is an eLearning Industry Crusader focused on advocating for advancement and change in the eLearning and professional development industry. An avid seeker of knowledge and continuous improvement, Susan is happy to share her research, observations, and thoughts regarding “all things related to learning and development.” When she’s not out on the learning crusade, Susan can be found with the wind in her hair riding her Harley or simply enjoying life with her husband, Steve, and her Siamese cat, Elvis, and with family and friends.