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DHC VISION convinces biotech start-up 4TEEN4 Pharmaceuticals

The Saarbrücken-based DHC Business Solutions supports the digitalization of quality and compliance management at 4TEEN4 Pharmaceuticals GmbH from Hennigsdorf near Berlin with its start-up program VENTURES. The integrated management system DHC VISION provides 4TEEN4 with a regulatory compliant digital solution for the control of its research-related processes and future clinical trials.

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DACHSER expands its Internal Control System (ICS) with DHC VISION

As one of Europe’s leading logistics providers with almost 400 locations worldwide, DACHSER not only focuses on “Intelligent Logistics”, but also on “Efficient Compliance”. DACHSER has opted for DHC VISION software as technological basis for its internal control system (ICS).

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REGTech Insights: Regulation or strangulation – MedTechs through medical devices regulation in a jam?

Medical technology is one of the growth sectors and showpieces of the German economy. But there are signs that this does not have to remain so: According to a new study [1], the industry is losing momentum and innovative strength. An excess of regulation could be one reason for this; in particular the Medical Devices Regulation, which has been in force since 2017, seems to have further aggravated the situation.

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BPM Tools and Software Overview – As a complete QMS, DHC VISION BPM is of course part of it

Hanser Verlag (Munich) has published a new market overview of BPM software products and solutions in the current issue of the trade journal “QZ Quality and Reliability”. Since quality management is increasingly responsible for the definition and modeling of business processes and the continuous improvement of business processes throughout the company, QZ presents a selection of current BPM solutions to facilitate the QM’s search for a suitable process management system.

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REGTech Insights: “Warning Letters” show deficits in standard Q-processes

It is quite astonishing: The dreaded “warning letters” (so-called 483s) of the FDA do not only flutter into the house when Compliance deficits in special areas are detected; they rather uncover primarily deficiencies in standard Q-processes. This diagnosis can be made when looking based on FDA data in for medical devices in 2017 and 2018 [1].

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REGTech Insights: How digitization will change document management in regulated industries

In an industry survey, DHC Business Solutions analyzed the trends of “digital transformation” in quality and compliance management. Companies from the life sciences, pharmaceutical, medical technology and other regulated industries were surveyed. The guiding questions were: How does digitization change the management of important documents? And the survey shows: The industries are in a state of upheaval. The results of the study have now been published.

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AkknaTek GmbH: MedTech Startup implements digital quality management system

AkknaTek GmbH, a Saarbrucken-based MedTech startup, has implemented a digital quality management system. This is remarkable as interlinking business development and digital quality management at an early stage is seen as a novel approach in a startup context. The innovative move is expected to bring the company to a new level in its development. Support is provided by VENTURES, a startup program launched by DHC Business Solutions.

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