The history of the W&H Group is characterized by innovation, social responsibility and a clear focus on people's health. Founded in Berlin in 1890, the company has developed over the decades into an international player in the medical technology industry and has one of its main sites in Bürmoos, Salzburg.
Today, W&H is a leading global manufacturer and developer of medical technology products, specializing in the dental industry. With a total of four additional production sites beyond the borders of Europe, the Group has a global presence and exports its high-quality products to 130 countries. This success is the result of a modern corporate structure and the continuous research and development of innovative product and service solutions.
The approximately 1300 employees of the W&H Group are committed and passionate about producing hardware and software products of the highest quality. These products are used in dental practices, dental clinics, dental laboratories and in oral and maxillofacial surgery. They support doctors and dentists in ensuring safe and gentle treatment for their patients. The guiding principle: "people have priority" always takes center stage.
Brief description of the project:
The integration of sproof sign is of crucial importance for W&H Dentalwerk. The digital signature ensures maximum security, compliance and flexibility with regard to the relevant documents in the product development and manufacturing process in order to meet the strict requirements of the FDA and MDSAP.
Why sproof sign:
"In our search for a new digital signature solution, we compared the major players in the industry in the course of a professional tendering process and ultimately came to the conclusion that sproof can absolutely play along"
Michael Knoblich , Director IT
How did the decision to introduce the digital signature come about?
Michael: "As a company, we are driven by the standards that we have to meet, including the fact that we have to use digital signatures as part of our product development and delivery process. We already had a signature, but it had to be replaced due to the end of support.
The medical device manufacturing industry is generally subject to very strict and restrictive requirements set by various institutes such as the FDA and MDSAP. For us, everything that has to do with the product and production process - i.e. the relevant documents - must be signed. We have to guarantee seamless reproducibility of the manufacturing process and be able to clearly verify who is responsible for which aspects of it via the digital signature."
What criteria were decisive for you when looking for the right e-signature provider and why did you choose sproof sign?
Michael: "In our search for a new digital signature solution, we compared the major players in the industry as part of a professional tendering process and determined that sproof sign absolutely had to be included in the shortlist. Functionally, there are no restrictions and because W&H itself is very strongly anchored in the region and relies on both its production site in Salzburg and Austria in general, it was important to us."
For which applications is the digital signature used?
Michael: "Most of our signature processes take place within the company because they are relevant for internal product development. This means that all test reports, plans and designs are signed digitally at our company. At the same time, projects relating to product development are also signed because they are incorporated into the development process and are therefore relevant to the FDA.
sproof sign ensures this traceability by allowing you to see exactly who signed which document at what time in the audit trail. The information is all stored in our operating system. This means that we log into our system, have the document there, sign it with sproof sign and then automatically store it in the PML again. This creates the audit trail both in sproof sign and in our system and thus represents the 'single point of proof' for our product documentation."
"I firmly believe that if sproof continues as it has done so far, then we are well on the way to where we are anchored in the dental industry."Michael Knoblich
In the EU, we distinguish between three signature standards based on the eIDAS Regulation. Which one is most commonly used by the W&H Group?
Michael: "In accordance with the requirements set by the FDA, we use the advanced signature. However, we also need a second factor for authentication. It is therefore not enough to simply sign a document with the normal Windows login. If we didn't provide this second factor, the document would be signed incorrectly and we would have a discrepancy in the event of an audit"
How does a digital signature workflow influence the production process?
Michael: "The digital signature really does play a decisive role in speeding up the production process. With our production volumes, it would simply not be feasible to sign the test reports and inspection reports in the conventional way. The time-consuming process of printing, signing, rescanning and archiving paper documents cannot work.
Our production concept is extremely efficient and specialized. We do not hold any stock, but produce the products within 24 hours of receiving the order. This means that the steel tubes are fed into the back of our production line and the exact product ordered is finished and ready for dispatch within 24 hours. In this highly dynamic environment, we cannot afford to slow down production with manual process steps. The digital signature is therefore an essential part of our entire production chain."
How was the integration into our interface recognized?
Michael: "I am convinced of the golden rule: "Success of the system = functionality x acceptance". Since we already see the digital signature as an essential part of our production chain, acceptance is absolutely given. The functionality of sproof sign was there from the very first minute.
We sign with just a few clicks. sproof sign was integrated into our most important systems as part of a very lean and structured process. The users did not have to change anything in their normal processes, but were able to incorporate the digital signature into routine processes very quickly. The signature remains in the usual place in the process flow.
We now also have the advantage of having an app that we can use to sign. That wasn't the case before. All of this has contributed to the rapid acceptance on the part of our employees."
How did the cloud integration work and what are the general thoughts on it?
Michael: "Our products are by definition in a very critical area. This is because our products are used directly on people. This also means that the issue of safety is very relevant for us, not only in terms of people, but also data security. The devices themselves in the dental industry are now also becoming more intelligent, which means that we have devices that need to communicate with the cloud. For us, the question of whether on premise (note: in contrast to cloud solutions, software is operated on our own servers on site) or not no longer arises because we are already networked with the cloud. We have no alternative. This means that we were not afraid of the cloud due to the need for technical progress, as was perhaps the case in other areas. As a result, it was no problem for us to implement a digital signature solution via a cloud application."
What data security and compliance standards must a software solution in your company meet?
Michael: "Our products are based on trust. They work and heal. Just as it is with the security of our devices, it is the same with the security of the customer data that these devices generate. There is no discussion about where the data is stored. For us, a European solution is now the only option."
What do you particularly like about sproof sign
Michael: "I know the sproof team and the managing directors personally from several projects in my professional career. I am completely convinced of their expertise in their domain!"
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