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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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Securing Competitive Advantages through Information Security

Joh. Meier Werkzeugbau GmbH (JMW) is specialized in the production of tools for serial production in the automotive sector. With the implementation of DHC Business Solution’s software system for information security the company complies with security requirements according to ISO 2700x according to VDA 3.0.

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ITM Isotope Technologies Munich AG ensures FDA Readiness with DHC VISION

ITM Isotope Technologies Munich AG is dedicated to the development, production, and global supply of innovative diagnostic and therapeutic radionuclides. A „digital turn” in quality management supports the company’s path toward business expansion, innovation, and economic growth. ITG Isotopes Technologies Garching, an ITM affiliated company, implements an integrated quality management system and thereby values DHC Business Solution’s regulatory compliance expertise.

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