How do you go from good intentions to a functional, well-established eQMS? What does it take to build a solution that not only complies with regulations, but also works in everyday life?
Choosing a system is just the beginning
There is a strong focus on choosing the right platform, which is of course important. But many projects get stuck right there, in the selection phase, and underestimate the work required to make the system really work in practice. Here it becomes clear that it is not primarily about technology, but about understanding needs, roles, and context.
Mattias Anderson , konsult på Plantvision med lång erfarenhet av datoriserade system inom GxP, har sett det gång på gång:
“It is not uncommon for a system to not quite meet the needs of the business, not because it is bad, but because it was chosen on the wrong grounds or implemented without a holistic perspective.”
In other words, even the best system risks failure if it lacks the right foundation, support, and alignment with reality.
One system – multiple user needs
eQMS projects are often driven by the quality department, but the system should almost always be used by more people. HR, research, production, legal—everyone has their own needs and perspectives. The challenge lies in the fact that these are not always brought into the project in time, which means that in practice, the system becomes an obstacle rather than a support.
Creating something that really works requires a broader understanding of the different ways in which the business operates. It's about more than technical requirements; it's about understanding people's needs and everyday lives.
“It is often QA that orders the system, but they are far from alone in using it. An eQMS affects the entire business, and needs vary.” By including more perspectives early in the process, you can avoid many of the frictions that otherwise arise after launch.
Simplify implementation module by module
Another recurring pitfall is the ambition to implement the entire system in one fell swoop. On paper, this may seem efficient, as everything will be ready at the same time. However, it can be overwhelming for both the project team and the end users. Everything has to be understood, tested, and put into use at the same time. An alternative is to implement module by module. A step-by-step implementation gives the end user a gentler learning curve and better conditions for adaptation, while also taking the pressure off the project by reducing complexity and enabling learning along the way.
“Start with one module, such as document management. Configure, validate, and let users get used to it. Then move on to the next one.” This way, each step gets the attention it deserves and users have time to get to know the system as it grows.
Clarify roles and responsibilities
To achieve success in implementation, the division of responsibilities must also be crystal clear. What does the supplier's commitment entail? What is expected of your own organization? How will validation and change management be handled over time? These questions need to be answered early on, otherwise you risk building uncertainty into the project right from the start.
Particularly in GxP environments, where regulations are extensive and formal requirements are high, clear boundaries are crucial to avoiding delays and quality deficiencies.
“Ultimately, it’s about interaction. The system should support the business, but sometimes a well-functioning system can also help shape effective working methods, especially in organizations where routines are not fully established from the outset,” says Mattias. That’s where the interaction between technology, processes, and people determines the outcome.
Build anchoring, not just function
Ultimately, technology plays a lesser role if it is not accepted by users. What looks good in the requirements specification can quickly become an obstacle in practice if users do not recognize themselves in the new system. Therefore, participation is central, not as a formal requirement, but as a prerequisite for creating real value.
It is often enough to give other parts of the organization the opportunity to understand what is going on and express their needs. This not only builds acceptance but also strengthens the end result.
“When everyone feels heard from the outset, it becomes easier to create a system that is actually used and appreciated.” This groundwork is not extra work. It is an investment in a project that will last.
Conclusion: success lies in the whole
Introducing an eQMS requires more than just choosing the right system, and getting it to work fully requires a holistic approach. A good system is not enough. It requires a clear strategy, the right expertise, realistic implementation, and responsiveness to user needs. If done right, the result is a system that not only meets regulatory requirements but also strengthens the business as a whole.
