Never file folders again!
How a validatable LMS significantly saves on time and paper
An interview with a representative from the medical technology industry
There will always be challenges to face when converting or introducing a Learning Management System (LMS). However, it becomes even more difficult if the learning platform also needs to map validatable processes. This is a particularly important issue in the medical, pharmaceutical and medical technology industries, as work processes and training courses must be fully documented. We spoke with a representative from the medical devices industry who recently made this type of changeover.
Hans-Heiko Müller, Team Manager for Organisational Learning at pfm medical ag
Hans-Heiko Müller works for pfm medical ag, an internationally operating medium-sized family business from Germany that offers special solutions in the healthcare sector. As Team Manager for Organisational Learning, he is responsible for the documentation of internal training and professional development.
He had already been working with imc's LMS and the imc Learning Suite since 2014 and initiated and oversaw the company's conversion to a validatable system. In this interview, he tells us how the conversion went, what challenges he and his team faced, and how many metres of DIN-A4 folders he now saves.
INFO
The term validation or validation obligation means that detailed evidence that a technical process has complied with requirements must be documented. Simply stated, the aim is to assure the quality of a product in order to prevent serious errors. This is extremely important for eliminating the endangerment of patients in high-risk industries such as the pharmaceutical industry and the manufacture of medical devices.
Hello Mr Müller, please tell us: What do validation processes and learning management systems have to do with each other?
The European Medical Device Regulation MDR and the U.S. Food and Drug Administration FDA impose very strict requirements for this. These requirements state that, if a computer-aided system is integrated into a quality-relevant manufacturing process, documented evidence of this must be provided.
This evidence must show that the system meets the requirements and will perform exactly as specified, both now and in the future. In other words, the system, or in our case the LMS, must be verifiable at all times, and every process must be clearly traceable. This applies, for example, to any changes made to training materials.
At pfm medical, you decided to take the step towards a validatable LMS in mid-2020; how did this come about?
There were several reasons. For one thing, we have to meet the legal requirements, and the European Medical Device Regulation, which was enacted in 2017 and is mandatory as of May 2021, included some innovations that had to be implemented.
Another consideration was the fact that, generally speaking, documentation prior to validation was very time-consuming. We had to carry out a great many procedures manually.
How can I picture this manual documentation?
Basically, all employees must complete certain training courses, for example professional development courses on the individual products. Depending on the type of training, it may need to be repeated or renewed on a regular basis.
Before the conversion, the documentation worked like this: We manually enrolled an employee in the course, and they were able to complete it either online in the LMS or in person. Afterwards, they had to print out a certificate showing that they had taken the test, acknowledge this with their signature and either submit the slip in person or send it by post.
After receiving the letter, we had to check whether the employee was really enrolled on this course and confirm their participation manually in the system. Because we are required to keep these records by law, and in some cases for decades, we manually filed the supporting documents in paper folders.
This added up to about ten running metres of DIN A4 folders within two years. My colleague and I spent several hours each week comparing and categorising. This standard procedure, which is the order of the day in many companies in the medical technology sector, ties up a lot of resources.
That sounds very cumbersome indeed. What does this process look like now with a validatable LMS?
All employees are assigned to different groups, and I can book these groups in specific training courses and onto specific learning paths. The additional professional development courses that are relevant for validation are also found there.
Let's take the example of medical device consultants who have to instruct doctors on our products. If I specify that the group with all consultants must attend a training course on the latest products every year, the system automatically books the entire group into the appropriate training courses. I can also set automated reminders (called escalation management) in the system. This will send a reminder to those who have not completed the training course by a certain time.
Once the employees have completed the course, they can log it directly into the system. To do this, they have to be logged in with their user name and password and also confirm their participation with their electronic signature (e-signature). That's it. We can then see when the employee has completed the training course, and the certificate is stored in the system. We don't have to print anything out or file anything extra.
Can you give us some insights into what was important to you when selecting a vendor?
We not only wanted support with the conversion of the system, but also help with the documentation going forward, because with every update, with every small change I make in the LMS, the potential impact of the change has to be documented. This is extremely time-consuming, and each update quickly adds up to 100 pages.
Theoretically, we could also do this work ourselves, in other words, run through all the scenarios completely and document them. However, I would need to hire at least one full-time employee to do this. We wanted a "comprehensive, worry-free package" that would not only cover the issue of security, but also make our work considerably easier.
What was the actual conversion process like?
First, we worked with imc to create a requirements analysis of the company's learning processes. This involves such aspects as the organisational structure and the structure of the learning content or learning processes. This was followed by the reconciliation of validation documents and the provision of user requirements and functional requirements including risk analysis.
Then, in the planning phase, we were provided with a development system (DEV system) for initial workshops. In the workshops, for example, the administrators were trained, and we set the system up and used it on a test basis together. In the third phase, a test system, or STAGE system, was put into production, and this in turn was tested. This was followed by the deployment of the productive system.
The process took just under four months altogether. If we had done it completely on our own, it would have taken us an estimated 18 to 24 months.
Did you have any fears or anxieties about the conversion beforehand? How did you deal with them?
Of course, we had respect for a project of this magnitude. But we saw the conversion as an opportunity to bring the old world into the digital age. For example, we took another look at all the processes and checked to see where they could be streamlined.
As a result, we now have training processes that are uniform for all employees, including those of our subsidiaries. There was a real change in culture which was also initiated by the fact that we worked with so many different departments.
At the same time, this presented a certain challenge, in that we first had to find out which "language" everyone spoke. Terms such as system or DEV system can be interpreted differently by each department. For example, since we worked with HR as well as IT, it was immensely important to make sure that everyone knew what was meant by which term. Clear agreements and a regular exchange are essential for this.
Were there any other challenges?
Personally, I didn't find it easy to relinquish some of the responsibility and rely on an outside vendor, because as I mentioned, I had already been working with the LMS since 2014, knew how it worked, and could make changes myself.
During the conversion, however, it was the provider, and not I who worked on the system. In a way, that was a leap of faith, because I didn't know exactly what was going on in the background. It made me a little nervous at first. However, we agreed on short sprints, in other words, weekly coordination meetings with the possibility of readjustments, so that I was reassured and could follow where we were in the process at any time.
However, you should be aware that you lose some flexibility with this sort of system. Changes that I could previously make myself with a check mark are now locked and have to go through a change process which has to be applied for, checked within the context of a four-eyes-principle and documented before it can be implemented. This strict process ensures the prescribed safety, but the price is less flexibility. Still, the advantages clearly outweigh the disadvantages for pfm medical.
What would you recommend to companies facing the decision to have their system changed?
My advice: You have to take a careful look at the processes in advance and then have the courage to adapt them to the technology. Not the other way around. This way you can be sure that there will be no problems during audits.
Thank you so much for all your insights!
Further information
Curious to find out more about pfm medical's validatable LMS? Then check our reference page.
Or download the whitepaper about how to master validation with an LMS.
Not enough? Then watch the webinar recording with Hans-Heiko Müller related to the topic validation in a LMS (German only).
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If you would like to learn more about imc's Learning Management System, check here for more information.
