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Overcoming Life Sciences Compliance Challenges – Part 2, What to Look for in a Life Sciences LMS

May 15 2017 | (1) Comment

Life Sciences LMS

Managing compliance training and employee development in a regulated environment is a difficult task. Compliance can be very fragmented. For example, a pharma company may require pharma compliance, safety compliance, and financial compliance, etc. There’s also high costs associated with compliance training, whether it be the cost of the training itself or the cost of pulling people out of their productive job to attend training.

Companies that rely on a cloud-based learning management system (LMS) to help them address compliance are able to develop a much easier and cost effective process. Quite often the LMS becomes the foundation by which companies can launch a “culture of compliance” and strategically implement compliance across the organization.

It’s important to remember that not all LMSs are created equal, especially when it comes to meeting compliance. There are several essential features an LMS should have that supports risk reduction in addition to helping organizations to meet their own quality and performance objectives.

  1. Supports role-based qualification training programs: Life sciences companies must be able to demonstrate that their employees have the knowledge to perform their specific job functions. Qualification is a formal process of assessing and documenting a curriculum of role-based training that assesses employees’ ability to perform their job responsibilities successfully.
  1. Provides an audit trail: 21 CFR Part 11 requires the “use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.” Therefore, a life science LMS needs to track all events and administrative actions performed in the system.
  1. Supports Electronic Signatures: 21 CFR Part 11 requires that all signed electronic records contain the printed name of the signer, date and time the signature was executed, and the meaning associated with the signature, such as approval, responsibility or authorship. These signatures cannot be deleted, copied, transferred to falsify an electronic record.
  1. Real-time Reporting Analytics: Organizations need to keep track of compliance training progress and completion to ensure that staff is completing training in their required timeframe. Additionally, retrieving critical training data quickly and easily is essential during a site audit. The LMS should provide the ability to customize and generate real-time reporting and analytics with speed and ease.

Managing compliance training and employee development in a regulated environment is a difficult task. However, by implementing a cloud-based LMS solution, compliance departments can establish a proactive approach to effectively manage compliance while greatly reducing their company’s risk.

Susan Distasio | eLearning Industry Crusader | ePath Learning, Inc.

Picture of industry crusader Susan DistasioAbout 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.