A Streamlined Method for Managing Employee Training and Regulatory Compliance

Managing a lab is a tough job for a number of reasons, especially for those lab managers who work in regulated industries. In those industries, keeping your team members up to date on the latest safety, environmental, or process information is critical to a company’s success. In fact, the more high-stakes your industry, the more critical this becomes and the more regulations your company must follow.

Add the challenge of disseminating the latest training to a global workforce spread throughout multiple facilities, and keeping your company up to date can seem like an insurmountable task.

Many companies and lab managers are turning to learning management systems (LMSs) and e-learning to centrally manage the process of creating, delivering, and tracking personalized training programs for employees. LMS systems allow for creating, assembling, publishing, delivering, and storing content, as well as sharing learning objectives and managing learner performance data. With an LMS, an employee’s level of compliance can be automatically tracked and reported, and users can be notified by the system to keep everyone on track; users can also be warned when they are close to noncompliance. Organizations can rapidly deploy updates and additions and can immediately access learning compliance data for regulatory and legal purposes.

Key standards for some organizations include Section 508, GMP, ISO 9000, QA, OSHA, QS 9000, and ISO 14000 QS, which are important to government agencies, and in particular the pharmaceutical, biotech, medical, auto, and manufacturing industries. These standards ensure that companies are compliant in areas ranging from meeting the quality standards of customers and stakeholders to meeting environmental standards for protecting employees on the job to maintaining the security of customer information.

For companies specifically regulated by the Food and Drug Administration (FDA), an LMS must be validated for 21 CFR Part 11 Compliance—meaning that it is compliant with the regulation that defines the FDA guidelines on electronic records and electronic signatures in the U.S. Part 11 specifically defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records.

Companies save time and money using an LMS; LMSs also help create a unified employee experience and help maintain a consistent brand image throughout the entire company. Most importantly, organizations benefit from being able to track the entire training process and have immediate access to information to identify which employees have completed their training, when their training was completed, or when their training is due.

LMSs provide training history documentation for each employee and include important information on course titles, descriptions, and dates training(s) was completed. An LMS ensures training consistency throughout a company by ensuring all employees receive the same customized content, delivery, and evaluation within a centralized learning environment. Companies benefit from consistent tracking and reporting that allows administrators to track progress and review employee scores as required. Administrators can also easily analyze data to determine areas where employees are successful or need improvement.

Gen-Probe Incorporated, a global leader in the development, manufacture, and marketing of rapid, accurate, and cost-effective nucleic acid tests—used primarily to diagnose human diseases and screen donated human blood—is a perfect example of a company working within a regulated environment. For years, Gen-Probe managed and tracked employee training manually using a paper-based system. As the company grew, a better solution was needed— one that would allow management to track learning across

multiple facilities and the entire global workforce.

Being in such a high-stakes business, Gen-Probe must ensure that its workers comply with operating practices and safety regulations to ensure the safety of all workers and customers. Many of these practices are necessary procedures implemented by the company, but others are imposed on the company by external regulatory organizations. Audits are conducted by the FDA and other regulatory bodies to ensure that the company continues to follow internal and external regulations. The company is regularly audited for product compliance and safety and for compliance across all of its manufacturing processes, customer interactions, production, and shipping.

Regular audits make tracking imperative

Regular audits assure government agencies that all Gen-Probe employees are up to date on the latest information and training, and confirm for Gen-Probe that all its employees have the latest information pertinent to performing their jobs correctly and safely.

Implementing an LMS provided some huge automation advantages for Gen-Probe, as it allowed the company to deliver training and to more easily track the courses each employee completed. As part of the implementation, Gen-Probe validated the LMS for 21 CFR Part 11 compliance. With the launch of the LMS, the company shortened the time required to compile reports and historical data for external audits.

Gen-Probe wanted e-learning in place for several course areas including business skills, desktop skills, and managerial training. The company also uses the LMS as a system of record for all training (procedural, classroom, conferences, webcasts, etc.) and to track the courses (both classroom and web-based) each employee completes. This allows the company to generate and print full reports on demand showing employee training history, and to sort information by topic, employee, course, type of training, and much more.

Timely generation and ease of producing training records on demand is a big advantage when using an LMS. “When our regulating bodies walk in the door, they will often walk around our facility, select employees and ask to see their training records. With the LMS, we can easily pull those records and have them in the auditors’ hands within 60 seconds. The auditors can then follow up with those employees on the items and procedures in which the reports show those employees are trained,” said Tina Asher, senior manager of organizational development and learning for Gen-Probe.

Company benefits globally from LMS

Before implementing an LMS, Gen-Probe used a mix of e-learning, Access databases, and spreadsheets to handle learning management and report tracking. The paper-based method was time-consuming, inefficient, and lacked the immediate visibility to training compliance the company needed.

“We had an unbelievable number of paper training records,” said Asher. “The LMS has allowed us to move from a paper records system to electronic records and has given us immediate visibility into training that we have never had before. It’s also allowed us to better manage our training from a global perspective since we are all using the same system.”

Prior to adding the LMS to manage the learning process, Gen-Probe had more than 50 employees who devoted a portion of their time to help track and manage the company’s training records. With the launch of the LMS, these people have turned their attention to more critical tasks, and Gen-Probe now has only one LMS administrator.

Since implementing its LMS, Gen-Probe has saved an estimated 2,900 hours that were previously spent administering and tracking training on paper. In addition, the deployment of e-learning courses has saved the company 400 instructor hours and reduced by 80 percent the time spent by managers reviewing and approving training records, all of which translates into real time and money savings for the company.

As an added bonus, the system has also resulted in a reduction in no-shows for classroom training. With its LMS, Gen-Probe can now send email notifications to employees to remind them of courses that need to be completed. Notifications are also sent to alert employees when new e-courses are added to learning plans, and when learning due dates are thirty days away, just five days away, or when the time frame to complete the courses has expired.

“We attribute our decrease in no-shows for classroom training to the fact that employees receive an Outlook meeting invite that puts the learning reminder right on their calendars,” said Asher.

Like Gen-Probe, most organizations must meet some level of regulatory requirements, or need to have regular reviews or recertifications to meet training standards. Using an LMS ensures the timely and consistent delivery of lessons and training and allows administrators/managers to view results in real time. The visibility this brings to organizations allows them to act immediately on issues that could put them at risk of noncompliance.

In industries where lives are at stake, LMSs go a long way to giving companies visibility into the knowledge base of their workforce. LMSs highlight areas where employees need improvement and track which employees are behind on courses. But the most valuable asset is the ability a company gains to immediately share training and compliance records with its governing bodies.

Lyle C. Emmott is the GreenLight product manager at SilkRoad technology and can be reached at Lyle.Emmott@SilkRoad.com. You can also follow Silk- Road on Twitter @SilkRoadTweets.