Case Study

Advalight Optimizes Quality Management with Laser Precision

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Challenge icon


  • Highly regulated industry
  • Heavy manual work processes
  • Lack of overview
  • Lack of transparency
Solution icon


  • Quick and easy registration
  • Automated workflows
  • Auto-generated statistics
Value icon


  • Documentation quality
  • Quick go-live within budget
  • Overview and transparency
  • Automatic reporting
  • Rich expansion possibilities

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Jakob Normann
[email protected]

Advalight was established almost 15 years ago as an innovation project based on the ideas of two prominent researchers within pioneering laser technology. Since then, the project has developed into a company that develops and produces high-quality medical laser devices. The technology is marketed globally under the name AdvaTx® – and is used to treat skin diseases and skin problems. This places high demands on quality management.

When you, like Advalight, produce medical equipment, there are a large number of legal requirements that must be complied with. It is an EU legal requirement that we live up to the standard ISO 13485, while the Food and Drug Administration (FDA) in the USA requires the implementation of ongoing controls, audits and system validation, etc., explains Head of Quality, Anni Degn. Added to this is our own level of ambition to be a technology leader within multi-wavelength lasers for medical use.

When Anni Degn joined Advalight, an older standard system was used for quality management. The system could not deliver the real-time overview that is needed in a modern, highly regulated production company. You couldn't extract data in an efficient way and you couldn't extract statistics from the system, explains Anni Degn. The work with quality control was therefore cumbersome and manual. All registrations were done on paper with the risks that manual workflows entail.

"Basically, a manufacturing company can make money in two ways. Either you have to be able to push much more over the ramp or you have to invest in quality and clean up the factory floor”. At Advalight, we produce quality, says Anni Degn with a firm smile and continues...

It was time to upgrade the core of the quality system – registrations!

"We therefore began to scan the market for a registration system that could meet all of our requirements and at the same time be easy to use. We looked at many systems, but found that the standard systems were too difficult to deal with. It was the classic challenge," says Anni Degn. "It would require serious refactoring, to adapt the systems to our needs, and in addition, we would end up paying for functionality that we have no use for at all - in our case up to 70%".

A solution out of the blue

Through my network, I contacted Thomas Riisager from Dcide, whom I know from other projects. 
Thomas Riisager has a lot of experience with process optimization and several of the ISO standards. He suggested building a custom application on TS No-code Platform . As a result of the no-code development speed and the platform's elasticity, it quickly became clear that the project could be realized on time and within budget. Even for a small business like ours. Anni Degn assembled her team and a quality management workshop was arranged, where all stakeholders had the opportunity to provide input for use-cases and data model respectively.

A solution quickly emerged

During the design process, we followed TS’ "Praximity" model, which is based on agile thinking, where the involvement of specialists brings the development very close to the business. After the first workshop, the basic sketch was in place and after just a few more workshops, the first version of the application was ready for elaborate testing. "The development of our very own quality management system has also had the secondary effect that the application is firmly rooted among the users. We have established a common internal terminology and we have gained better insight across the departments".

The current core functionality includes: CAPA, Nonconformity, Service and ECR. All registrations are made easily in the application, the workflows are digitized based on our established procedures and automated as far as possible. "Thus, we have a full overview of all cases, their current status and which actions are required, if any," explains Anni Degn.

The application provides all the transparency and statistics we need, and of course data can be exported to Excel if need be. Using role-based access rights, we control exactly who has access to what in the application. This also means that customers and partners can create service/support cases directly in the system.

Minimal resource consumption

I knew from Thomas that the development speed was high, says Anni Degn, but we have taken off much faster than I had ever dared to hope for, and our internal resource consumption has been absolutely minimal.

Naturally, we expect to expand the system over time, but with TS No-code Platform we see no limitations, only possibilities. We know that all of our requirements can be met, and if we are subject to changes in external legal requirements, it is a simple matter to adapt the application. Even while the application is live. In the time I have worked with quality management, I have never experienced a digitalisation project being incorporated and put into operation so quickly.

A good business case

It is a little early to assess the full value of the business case, since we have not been in operation that long, but we can already see that we are saving a lot of time on registration approx. 5 – 7 minutes per case. And automated notifications to those responsible in the event of errors, deviations or changes, this alone, ensures a high degree of efficiency.

There is no need to hand over cases, since everyone has access to the same data in one central place, and our weekly change meetings, that used to take an hour can now be done in half the time or less.

"In addition, we will be taking advantage of the statistical functions of the application as the database increases, and this is yet another benefit of having all the information ready at hand", emphasizes Anni Degn.

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