D4InfoNet

SUCCES STORIES

Heka Dental A/S

“ We ended up choosing D4InfoNet because it is a simple and user-friendly system that can validate our software as a whole. We received a good offer for a standard solution that just suited us, and D4 has implemented the system and completed the validation quickly and without problems. ”, Says quality manager Claus van der Goot.

A system that handles both
document management and validation

When Heka Dental A/S needed to invest in a digital platform, the choice fell on D4InfoNet because it is a simple and user-friendly system that can also validate the company’s software. “We were given a good offer on a standard solution that was most suitable for us,” says quality manager, Claus van der Goot.

Why are you validated?

It is a requirement from the authorities that we comply with EN/ISO 13485, which is a standard for the production of medical equipment and there is a requirement that we test, validate and verify everything we do – including our software.

Validation provides us with certainty that the software does what we want it to do. We do not have defective items and the documentation is always correct. However, we don’t only consider certification and validation as a question of complying with the authorities’ requirements. We also consider it as an opportunity to strengthen our processes and we use it actively as a reason to improve and develop our company.

How have you found the validation process to be?

Previously, all our documentation was Word documents that had to be signed every time something was changed – and that was often. It was a huge job to keep control of it all and, therefore, we decided to find a digital solution that could meet our needs for both document management and validation as a standard solution.

When we were ready to implement the validation, we just called D4. They gave me a test protocol and the only thing I had to do was to give them access to the system with user names and passwords. They then handled it all and were able to send a report to me in the course of a couple of days.

In regard to validation, the challenge is mostly in avoiding that small spreadsheets or programmes are used round and about in the organisation, because everything has to be validated, of course. It is also important that you don’t make small changes in the code, which collides with the validation, because you then need to implement a new one and that can be expensive. Consequently, we have chosen to adapt to the standard solution and we are delighted about that. It suits our needs very well.

What do you see as D4InfoNet’s greatest strengths?

When we searched the market, we looked at a couple of American systems, among others, but they were too expensive and with the time difference in relation to support, it would just be too inconvenient.
We ended up choosing D4InfoNet because it is a simple and user-friendly system that can validate our software as a whole. We received a good offer on a standard solution that was most suitable for us, and D4 has implemented the system and carried out the validation quickly and without problems. It also means a great deal that they have experience with our industry.

What are your best tips to ensure a good validation process?

You need to make sure that the digital management system you buy contains validation, because otherwise the company has to do the validation itself. This costs manpower, time and perhaps external consultants as well.




Since 1965, Heka Dental A/S has delivered patient chairs for dentists across most of the world. The products are based on high quality, design, reliability and ergonomics and, today, Heka Dental is a market leading supplier in Scandinavia. The company is family-owned and all production, development and administration takes place in Denmark. Delivery, installation and servicing are handled by a large network of dealers.

www.heka-dental.dk

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