PRO.FILE keeps processes
flowing in medical engineering

In medical engineering, ensuring compliance with industry standards such as FDA Title 21 CFR Part 11 is business critical. It is essential for the industry to always fully comply with requirements and to document their compliance. PRO.FILE automates many of these tasks and, among many other things, lets you

  • implement robust, system-based audit trails
  • automatically create folders of documents needed to obtain approval
  • standardize the electronic documentation of digital signature and workflows (approval processes)

Reference customer Medtron AG

Software-based security and compliance in a highly regulated environment

Medtron AG is a great example of how PRO.FILE is able to control the complex development and approval processes associated with quality control in medical manufacturing and why it is so important to have a Product Data Backbone as a single source of truth.

  • Create and maintain quality control manuals
  • Control development and approval processes through ECR – ECO – ECN
  • Establish template management
Challenge & solution
The challenge

The company was looking to replace its disk-based document management with a DMS that would also allow them to map their internal development and approval processes into the system. The overall objective was to optimize their engineering and quality management along with their audit and training processes in a highly regulated environment.

The solution

Thousands of documents were migrated to and centralized in PRO.FILE and structured using metadata. The status management and information control capabilities of the DMStec 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 attached to work instructions and every single employee training is documented.

We are a technology-driven company and for us, DMStec is the perfect approach to embrace the digitalization of document-heavy business processes. More so than any other vendor, PROCAD was able to meet all of our requirements.

Press release Medtron AG
Press release Medtron AG
Read the press release to find out how Medtron standardized its quality control process in compliance with applicable regulations and is now able to generate audit trails at the click of a button.

Reference customer Dürr Dental

Transparent project collaboration

Dürr Dental is a real-life example of how medical manufacturers and other companies operating in highly regulated environments can ensure secure and compliant collaboration and why it is also important for your business to implement sophisticated compliance controls both inside and outside the organization.

  • A data exchange platform to ensure visibility and control the exchange of project documents
  • Project rooms as a single point of communication
  • Reduced workload on IT administrators: no more maintaining and configuring the FTP server, no more user inquirie
Challenge & solution
The challenge

When projects require multiple companies to collaborate on technical documents, their exchange can become a real hassle. Conventional data transfer mechanisms like email and FTP come with a number of disadvantages: no data security, out-of-control document versions and overwrites, limited file size.

The solution

Dürr Dental deployed PROOM as software-as-a-service; the system is hosted by PROCAD on Windows Azure, Microsoft’s cloud computing platform, making it a turnkey solution. The PROOM infrastructure ensures unlimited scalability and high availability – without having to invest in administration or hardware.

With PROOM, we get a single platform for all project teams and all of their different members. We are able to track and log every access to a file and any changes to a document.

Dürr Dental success story
Dürr Dental success story
Read the success story to learn how Dürr Dental exchanges CAD models and other project documents stored in PRO.FILE with development partners, customers, and suppliers with complete audit trails.

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