Legal and regulatory requirements oblige companies to maintain detailed, secure and computer-generated records. A research project involving DHC Business Solutions, the German Research Center for Artificial Intelligence (DFKI) and the medical technology specialist AkknaTek is now investigating how blockchain technologies can be used for these audit trails.
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.
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.
DHC Business Solutions GmbH & Co. KG announces the successful completion of the “digiCOMP” research project. An innovative solution for information management within the framework of digital quality and compliance processes was developed and tested. The new “information logistics” approach provides accurate and reliable data for management decisions.
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].
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.
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.
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.
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.
CROMA-PHARMA GmbH is an Austrian family business with global operations and specializing in aesthetic dermatology. CROMA-PHARMA valued DHC’s expertise in regulatory compliance when implementing an integrated quality management software solution.
