The history of the W&H Group is characterized by innovation, social responsibility and a clear focus on people’s health. Founded in 1890 in Berlin, the company has developed over the decades into an international player in the medical technology industry and has one of its main locations in Bürmoos, Salzburg.
Today, W&H is one of the world’s leading manufacturers and developers of medical technology products, specializing in the dental industry. With a total of four additional production sites beyond the borders of Europe, the Group is globally positioned and exports its high-quality products to 130 countries. This success is the result of a modern corporate structure and 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 oral and maxillofacial surgery. They support doctors and dentists in ensuring safe and gentle treatment for their patients. The guiding principle is always “people have priority”.
Company Name:
W&H Dentalwerk
Short description of the project:
The integration of sproof sign is of crucial importance for W&H Dentalwerk. The digital signature ensures the highest level of security, conformity and flexibility with regard to the relevant documents in product development and the 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 big players in the industry in the course of a professional tendering process and ultimately came to the conclusion that sproof could absolutely play along.”
How did the decision to introduce the digital signature come about?
Michael Knoblich: “As a company, we are driven by the standards that we have to meet, and that includes using the digital signature in the course of our product development and delivery process. We also already had a signature, but it had to be replaced due to the expiration of support.
The medical device manufacturer industry is generally subject to very strong and restrictive requirements set by various institutes such as the FDA and MDSAP. With us, everything that has to do with the product and production process – i.e. the relevant documents – has to be signed. We have to ensure seamless reproduction 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 in your search for the right e-signature provider and why did you choose sproof sign?
Michael Knoblich: “In our search for a new digital signature solution, we compared the big players in the industry in the course of a professional tendering process and found that sproof sign absolutely had to be shortlisted. There are no functional 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 use cases is the digital signature used?
Michael Knoblich: “Most of our signature processes take place in-house because they are relevant for internal product development. This means that all test protocols, plans and constructions are digitally signed by us. At the same time, however, there are also projects related to product development, 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 dial into our system, have the document there, sign it with sproof sign and then automatically store it back in the PML. As a result, the audit trail is then formed both at 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 before, then it is the best way to get to where we are anchored in the dental industry.”
Michael Knoblich
Director IT
In the EU, we distinguish between three signature standards based on the eIDAS Regulation. Which one is used most often by the W&H Group?
Michael Knoblich: “In accordance with the specifications set by the FDA, we use the advanced signature. In addition to this, however, we need a second factor for authentication. So it is not enough to simply sign a document with the normal Windows login. So, if we didn’t provide this second factor, the document would be incorrectly signed and we would have a discrepancy in the event of an audit.”
How does a digital signature workflow affect the production process?
Michael Knoblich: “The digital signature actually plays a crucial role in speeding up the production process. With our production volumes, it would simply not be feasible to sign the test reports and test 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 special. We do not hold stock, but produce the products within 24 hours of receipt of the order. This means that the steel pipes are brought into the back of our production facility and within 24 hours the exact ordered product is completed and ready for shipment. In this highly dynamic environment, we cannot afford to slow down production through 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 Knoblich: “I am convinced of the golden rule: “Success of the system = functionality x acceptance”. The acceptance, since we already see the digital signature as an essential part of our production chain, is absolutely given. The functionality of sproof sign was also there from the very first minute.
We sign with just a few clicks. sproof sign was integrated into our most important systems in the course of a very lean and structured process. Users did not have to change anything in their normal process, 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. This was not the case before. All of this contributed to the fact that acceptance on the part of our employees was quickly established.”
How did the integration of the cloud work and what are the general thoughts on it?
Michael Knoblich: “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 topic of security, not only for people, but also for data security, is very relevant for us. The devices themselves in the dental industry are also becoming smarter, which means we have devices that need to communicate with the cloud. For us, the question arises as to whether on premise (note: in contrast to the cloud solution, software is operated on on-premise solutions on their own servers on site) or not at all, because we are networked with the cloud anyway. We have no alternative. This means that we were not afraid of the cloud due to the need for technical progress, as we may have been in other areas. As a result, it was no problem for us to present a digital signature solution via a cloud application.”
What standards in terms of data security and compliance must a software solution meet in your company?
Michael Knoblich: “Our products are based on trust. They work and heal. Similar to the security of our devices, it is similar to the security of the customer data that these devices generate. There is no discussion about where the data is stored. For us, only a European solution is now an option.”
What do you particularly like about sproof sign
Michael Knoblich: “I know the sproof team and also the managing directors personally from some projects in my professional career. I am fully convinced of the competence in their domain!”
