The key to good end-user training for eQuality Management Systems

by Alicia Whitney |
Oct 13, 2021 |
We all know that training plays an important part in the Quality area. It is the responsibility of the Quality department to ensure that employees are properly trained to ensure all regulatory compliance. When you implement an electronic Quality Management System (eQMS), training is even more essential because effective training will guarantee that people are able to follow the processes to support the defined quality rules, which will assure product quality.

At the end of a QMS implementation project

The only important question is how well the users accept and use the system. You may have done the project perfectly: staying on-time, in-budget, with high quality; but in the end, none of these matter if the users are not using the system.

Who hasn’t experienced this scenario? A challenging and time-consuming project is finally finished! The new application has been implemented to support the team’s daily work and improve efficiency. Maybe new processes were designed that are changing the way things are done. For sure the team needs to learn to work with the new tool.

“New” means something unknown.

“New” does not mean better.

For the new application a small group of people have been involved in the requirements gathering and testing. They have done their best to properly represent their colleagues or functions. They have tried to think of all the scenarios that need to be covered by the new application. They are very proud of all the effort they have put into this. But in the end, the new application will be used by a much wider group of people who might not be as enthusiastic about it but will have to use it nonetheless.

So how can you get these people on board? The first step, as in many other cases, is good change management and communication throughout the project. The project team should maintain an open-door approach, continuously sending out brief, yet informative communications about the progress of the project. The goal here is to get everyone interested from the beginning and maintain their interest by keeping them up-to-date.

Don’t make the new software a surprise

An important decision in the implementation project is the training approach and creation of the training material:
• How should the material be structured?
• What is the best way to conduct the training?
• Would it make sense to follow a train-the-trainer approach?
• Will everyone be trained together, or does it make more sense to split them into groups?

We all know we have special challenges during these times, and it might not be possible to get everyone in one training room (which is usually the preferable approach). So, what are the options? Are there best practices for organizing these trainings?

I’m happy to share some insights and experiences that we have collected over the last few years with different customers.

In many cases, the time and effort required for creating good training material is underestimated. Projects are under time constraints, sometimes delayed – and then you are supposed to think about the correct training approach and spend days or weeks to develop high-quality, effective training material?

The answer is yes – you should think of the right approach and yes – you should definitely invest enough time for the creation of the training material. It is worth it! All the time and money you are spending for the project will be wasted if the application is not adopted and properly used by the business users.

The first impression counts

You only have one chance to win over the business users and get them to use the system, so make the first impression count. The training should be a mix of an overall system overview plus special topics based on daily activities of the users. In many cases, it makes sense to split up the training by roles. It is always a good approach to provide an overall overview first and then focus on the role-specific details.

Typically, you will have different types of personalities to accommodate, but you know your team members inside out. Identify the reluctant candidates early on and make a concerted effort to get them excited about and invested in the new system. Some of the potential detractors can be turned around to become promoters of the new system. It is normal for people to be reluctant to change; that’s part of human nature as change can be a difficult process to handle. Always keep this in mind.

Take all concerns seriously and implement a change management process

Include someone from management or the project sponsor at the beginning of the training. This person should explain the motivation behind the project, discuss the importance, and identify the improvements that will be realized once the application is implemented. All attendees will be part of something important. The worst scenario that could happen is where the users refuse to use the system. It must be a priority to prevent this from happening. But what can you do?

Involve these people. Make them feel important. Even if not needed, create a title for them such as “Local Business Advisor for….”, “Super …. User” or “Local Admin”. Don’t focus on the people who are already convinced, instead choose the people who are not. You might think is this crazy! Why should I do this? Because this is the key to success! If you can get the reluctant users to support and promote the new application, you are well-positioned for a successful start and it is likely that the positive spirit will continue after go-live.

Make sure you explain not only the technical functions of the system but also why it needs to be used in the defined way. There were reasons why it was designed like this; make these reasons transparent. Ask for any questions or concerns and offer a way to collect feedback. Everyone has a responsibility to help improve the system, so give everyone the opportunity to share their thoughts. Make sure to emphasize that feedback is very welcome and important. No system is 100% perfect. Implement a change management process to make sure you not only collect but also review and evaluate the feedback. Keep the requestors in the loop about what is happening with their requests.

Even if you provide excellent training, the users will not be able to remember everything that was covered during the training session. To support the users after the training session, be sure to provide high-quality training materials. These materials should be easy to understand and simple to follow. When creating the training materials, consider any obstacles users may face and include guidance to ensure these obstacles are easily overcome by the user. Good training material should be a mix of step-by-step instructions on how to use the system and explanations to help the user select the correct values or enter the correct type of data.

Training, tools, and tenacity

In the end, the regular use of the system will automatically improve the competence and confidence of the users. But in the beginning, providing users with training, tools, and tenacity will promote long-term data quality. We hope the insights and ideas provided can help you generate and conduct successful training for your users.

Please reach out to us to discuss your specific challenges. Our team of consultants will be happy to connect with you in a free assessment call to learn about your individual situation and to lay out for you how fme can support you on your path to a successful and effective training execution.

About the author

Alicia Whitney has been working with compliant, validated computer systems since 2010 when she started her career at a small pharmaceutical company in Pennsylvania, USA. Collaboratively implementing and validating document management, quality management, and inventory management systems, she has gained knowledge and experience in many areas of the pharmaceutical industry. Since joining fme Life Sciences in 2018, Ms. Whitney has continued to provide an experienced perspective when gathering requirements and guiding assessments for client implementations. Ms. Whitney continues to build on her experience, now holding certifications on TrackWise Digital QMS and VeevaVault Platform.

fme Life Sciences is a leading provider of business and technology services supporting the deployment of Content Services and ECM solutions to its clients in the Life Sciences Industry. We act as a trusted advisor and systems integration specialist across the Clinical, Regulatory and Quality and Manufacturing domains in Europe and North America. We do not exclusively recommend or promote any platform or vendor, but rather we focus on providing our clients with an independent perspective of the solutions available in the market.