Amann Girrbach

The German-Austrian company Amann Girrbach distributes medical products all over the world. As different as cultures can be, one thing is true across all countries: medical devices must be flawless in every respect. Amann Girrbach therefore has to ensure the excellent quality of its products and services while also meeting the justifiably high requirements from regulatory authorities. And these requirements have been increasing for years.

With over 430 employees worldwide, Amann Girrbach manufactures around ten product groups and therefore has to document hundreds of work steps, recipes, mixing ratios, processes, procedures and quality assurance measures. And it must do so for different authorities in different countries. The technical documentation must also comply with the guidelines for good working practice, often referred to as “GxP.”

In Germany, for example, medical products may be tested by TÜV Süd, Dekra or TÜV Nord. In the USA, the Food and Drug Administration (FDA) monitors the quality of food and pharmaceuticals; in other countries there are comparable authorities. Different countries, different requirements, different forms to fill out—which means a lot of work for Amann Girrbach to be able to offer its wide range of medical products worldwide. Especially since, until recently, all the technical documentation was still on paper.

Keeping technical documentation for medical devices up to date

“We operate in two locations,” describes Philipp Wildgrube, Regulatory Affairs Manager at Amann Girrbach. “In Koblach in Austria and in Pforzheim. Over time, it became increasingly difficult to keep the technical documentation up to date.” Another difficulty, according to Wildgrube, was that “documents sometimes took a long time to get from one location to the next when sent through the mail.”

Amann Girrbach was therefore looking for a partner to digitally map its technical documentation. The system had to be flexible and individually configurable by the user. The company also needed a software provider with extensive expertise in the field of GxP.

Amann Girrbach found out about the d.3ecm document management system from d.velop AG at the Control industrial trade fair in Stuttgart. This system allows companies to digitize information and processes quickly and effectively. The document management system serves as the central storage location for all of a company’s information and documents, and the industry-specific and GxP-compliant add-on modules and services from d.velop Life Sciences allow the system to be adapted to the individual requirements of Amann Girrbach.

GxP-compliant document solutions

d.velop Life Sciences GmbH is d.velop AG’s competence center for GxP-compliant document solutions and electronic quality management solutions. With around 40 employees, d.velop Life Sciences serves more than 70 customers, most of whom are active in fields requiring GxP validation—for example in medical technology or the pharmaceutical industry.

Especially in the medical sector, companies must give increasing thought to the technical documentation of their products, as regulatory requirements from legislators and testing authorities have been rising for years. The d.ecm document management system helps companies to keep track of and monitor this documentation. Amann Girrbach quickly availed itself of this solution.

Flexible ECM solution for the pharmaceutical industry

“The main reason for choosing the d.velop solution was its flexibility,“ describes Philipp Wildgrube. “Right from the start, we were able to have the document management system individually configured according to our needs, so that in the end it matched our requirements perfectly. Other suppliers couldn’t deliver a solution like that.” The requirements included, for example, the ability to map the structure of Amann Girrbach’s technical documentation.

Amann Girrbach and d.velop Life Sciences started their joint project in 2015 and began installing a document management system, optimizing processes and digitizing information. Benefits were quickly seen, and since then adaptation work has continued periodically, as the legal framework is constantly changing. One key driver was the new European Medical Device Regulation (MDR) from 2017.

Technical documentation 2.0

The requirements placed on medical companies by regulatory authorities are many and are often quite stringent. One such requirement is that original documents cannot be changed after they are released. “Our software can map that,” says Frank Laumann, Head of Service and authorized signatory at d.velop Life Sciences. Using the d.velop Life Sciences client, Amann Girrbach can now map its GxP processes accurately and reliably.

The advantages of the software include:

• Complete, digital management of dossiers
• Digital creation and updating of technical documentation in compliance with the Medical Device Regulation
• Elimination of untidy file servers with multiple filing systems and redundant folder structures
• Minimization of process times for the creation, revision and release of dossiers
• Versioning of dossiers
• Export of entire dossiers
• Completeness checks for dossiers

“The information is now usefully and logically structured,” says Philipp Wildgrube. “With d.velop, the process was nice and easy. Their software allows you to map just about anything you want.” One of the greatest benefits of the GxP-compliant, digital document management system is the fast access times. Employees no longer have to leaf through stacks of paper or search through the mailbox. According to Laumann: “Information can be found much faster, and all employees who need access can access the information from a central location.”

Support team and contact persons

For Amann Girrbach, fast access to information is one of the most important requirements for a GxP-compliant document management system. “The big advantage of the d.velop product is that we can access documents quickly and without a lot of effort,” describes Wildgrube. He adds: “We are very satisfied with how the system works and with the service we have received from the support team.”

Project partner

Since 2007, d.velop Life Sciences GmbH (formerly gabari GmbH) has been d.velop AG’s competence center for GxP-compliant documentation solutions. Thilo Gukelberger, one of the two founders of d.velop AG, manages the company together with other long-standing employees of d.velop AG. They are also key co-inventors of the d.3ecm basic product, which is now used by more than 8,500 customers worldwide as a central ECM/DMS/archive system. The solutions from d.velop Life Sciences GmbH are complementary to d.3ecm. They primarily address document-based processes in manufacturing/production and quality management. In addition to customers from the classical life sciences industry (pharmaceuticals, medical technology, food supplements, cosmetics), companies from the steel industry and the services sector also rely on the solutions of d.velop Life Sciences GmbH.