Life science firms rely on cloud-based learning management systems to address compliance
Managing training and regulatory compliance in the life sciences field is extraordinarily complex. Among other things, it requires creating educational material covering hundreds of standard operating procedures (SOPs) both in manufacturing and sales and marketing, validating that the training has been attended and creating an audit trail that regulators such as the U.S. Food and Drug Administration can follow. Larger companies have the additional complexity of operating in a multinational environment.
Dan Morris, a former manager of learning development at Johnson & Johnson and now a training consultant, remembers a time before there were sophisticated commercial learning management systems to manage all that. “Twenty years ago most of the learning management was done on spreadsheets or in DOS-based databases. We were very limited in terms of what we could do other than run reports on who has been trained on what,” he says.
But today pharmaceutical companies can turn to an array of cloud-based learning management systems that ensure government compliance for electronic signatures and record-keeping, including compliance with a regulation called Title 21 CFR Part 11, which specifies how validation is handled to make sure inputs are not manipulated and audit trails are available.
Morris says that as companies evaluate those systems, Title 21 CFR Part 11 compliance is a must. The LMS also must connect to data in other systems the company uses. All aspects of life sciences are really driven by policies and procedures, Morris explains. Typically companies have high-level corporate policies, directives and standard operating procedures. They are all retained in electronic document management systems. “So it is really important for an LMS to be able to communicate with that,” he says.
For example, a manufacturing site working on a pharmaceutical product may have up to 1,000 procedures. “So you take 500 people times 1,000 procedures—that is a lot of transactions,” Morris continues. “If tracked manually that would be unwieldy. Whatever LMS you have, it must be capable of interfacing with content management systems and human resource systems.”
Karen Bigelow-Varney, a training executive with a global contract research and manufacturing organization with approximately 1,000 employees, says her company has been using a cloud-based LMS from a company called Noverant for about 10 years. The LMS handles both in-person and online training for grants that come from the National Institutes of Health (NIH), Sarbanes-Oxley regulations and standard operating procedures.
The system automates the assignment of training based on job role, product or country. It offers weekly reports to administrators and heuristics to improve measurement. Following training, Bigelow-Varney sends out assessments. “If I see that for two particular questions, 90 percent are getting it wrong, I know it is one of two things: the instruction didn’t cover the information adequately or the question is poorly worded,” she explains. Then Bigelow-Varney has the data to work with the compliance team to address those issues.
Bigelow-Varney notes that the LMS makes the audit process much easier. “Before the company used the LMS, they used to have to go through personal portfolios for each employee by hand and that was nightmarish,” she says. Once you put it in the LMS, you can call something up in a few seconds. “I can search for one training session an employee had on a specific date. Rather than hunting through 149 pages of a transcript, I can pinpoint it,” she explains.
Analytics features can help firms better understand the impact of training and the costs. Noverant CEO Frank Gozzo says, “We can help them decide when to offer in-class training, webinars and online asynchronous training. We are agnostic about it, but which is the most effective? And it is not the same answer in every company.”
He adds that the need for an LMS becomes apparent as a life science company grows from a startup to a more mature company. “Small and medium-sized companies tend to get in trouble when they don’t standardize their programs,” he says. You show up for the first day of work and Betty at the front desk knows that you are going to be in this line of work, so you have to have this type of training and she hands you something that tells you to take this class and this online test, he says. “But what if Betty is out sick that day? Nobody knows what to do with the next hire. It is not automated. The LMS automates the entire onboarding process and maintenance.”