Karlsruhe, March 25, 2019. MEDTRON AG, one of Europe’s leading manufacturers of contrast medium injectors, has replaced its drive-based document management system with the PRO.FILE document management system (DMS^tec). With the PROCAD solution, MEDTRON employees can now view and use documents from every single PC workstation throughout the company. Operating in the highly regulated medical engineering industry, the company was looking for a technical document management system that would allow it to model its internal development and approval processes in an effort to optimize development and quality management along with its audit and training processes. PRO.FILE is also used to manage the company’s templates.

MEDTRON ensures the consistently high quality of its documentation through a standardized process for the creation and editing of technical documents such as process instructions, work instructions, instructions for use (IFU), and service manuals. Now that MEDTRON no longer stores its technical documents in distributed Explorer structures, which meant it had no control over the process, but rather uses PRO.FILE as its central DMS^tec system, the company can rest assured that its employees will always work with the latest, approved document versions. To this end, thousands of documents (Office, PDF, Visio and more) were migrated and structured using metadata.

Approval processes in a quality management (QM) ecosystem require tremendous back-and-forth communication and many different document versions. The company used to create PDFs from Word documents, print them out, have them signed, scan them once again, and store them on a network drive. The file name was the only source of information regarding a document’s version and relationships. The status management and information control capabilities in the PRO.FILE DMS^tec system now provide a complete audit trail of all changes to a document along with the change process and its different access authorizations (creator, reviewer, approver). Quality assurance certificates are maintained in PRO.FILE and attached to the work instructions. It is now possible to seamlessly track which employees were trained based on which set of work instructions. Template management makes the creation of new documents much easier.

More than just a QM system

With its decision to introduce PRO.FILE as its new top-level product and document lifecycle management system and single source of information, MEDTRON was able to kill two birds with one stone. It has given quality managers a DMS^tec software for their documentation needs that provides a much larger range of functionality than simple QM or DMS systems alone. At the same time, the company’s design department was looking for a solution that would allow it to replace its previous and inadequate CAD data management system.

Marius Schönberger, Head of IT at MEDTRON: “Medical engineering is a highly regulated industry, which means we are faced with constant inspections, audits, and ongoing change management. This means that we must rigorously document our quality management and manufacturing processes to comply with regulatory requirements. The biggest plus of the DMS^tec solution is its ability to adapt to the challenges and requirements of our industry. The PRO.FILE DMS^tec system is so open that you need no programming skills at all to create new document types or forms.”

Going forward, MEDTRON plans to also implement best practice PLM processes such as engineering change management using the PRO.CEED add-on to PRO.FILE. Sales and marketing along with the company’s contract management are also to be incorporated into the PROCAD solution.

Image: In the highly regulated medical engineering industry, MEDTRON products are subject to constant inspections