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.

In the “regulated environment”, important instructions for production, hygiene in the laboratory, filling and packaging of active ingredients, etc. are recorded in document, especially in so-called “Standard Operating Procedures” (SOPs). Their content and validity as well as their distribution to the right people in the company are strictly regulated. And since there are often several thousand such documents, their proper administration is a real challenge for companies. Companies in the life sciences, pharmaceutical industry, medical technology and chemistry are subject to tight regulations; such regulations also apply to companies active in the production of cosmetics, therapeutic products, and food.

DHC Business Solutions has analyzed the changes in this central area of quality and compliance management with a survey as part of the “SOPassist” research project. Quality experts from companies in Germany, Austria and Switzerland were surveyed; the results of the survey have now been published. The survey results make it clear that some remarkable changes are to be expected in the area of document management in the coming years. Automation of processes and use of multimedia-enhanced documents are two of the main trends. In addition, “Compliance Analytics” is on the advance, i.e. key figures and performance indicators for the management of compliance and quality processes.

These trends entail significant changes in working practice. Some of them are examined in more detail in the whitepaper now published. “We see adjustments on the level of the processes, the work organization and the technical infrastructure as well as in the quality culture altogether”, remarks Dr. Wolfgang Kraemer, Managing Director of DHC Business Solutions. “The sooner companies devote themselves to these aspects and take the first steps, the better the upcoming digital transformation will succeed.

The results are published in the white paper “Status quo and Trends in the Management of Standard Operating Procedures” (in German). The e-paper can be requested via the Media Center or by sending an e-mail to . The research project “SOPassist – Assistenzsysteme für das digitale SOP- und Compliance-Management in der GMP-regulierten Produktion” (SOPassist – assistance systems for digital SOP and compliance management in GMP-regulated production) is funded within the framework of the ZTS – Zentrales Technologieproramm Saar (Central Technology Program Saar) with funds from the European Regional Development Fund (EFRE).