InnoLAB – Transformation of innovation into products
Together with international research institutions and application partners, we are testing the next generation of technology scenarios in quality and compliance management. In this process, research results are transferred directly into applicable processes, products or platforms.
innoLAB – Innovation through research and development
innoLAB stands for innovative technologies, new developments, fresh thinking and application-oriented solutions. innoLAB is therefore the incubator for innovation at DHC Business Solutions in the areas of Services and Technology. Our innovation strategy is integrated into the product strategy of DHC Business Solutions; third-party funded research and development projects in innoLAB extend the “open innovation” approach that the company pursues together with partners and customers. In this way, employees of the company contribute to the implementation of new ideas in a dynamic environment and contribute to the joint further development of the company and its solutions:
TOGETHER FOR QUALITY – AND INNOVATION.
RegTechsmart: AI-based regulatory technologies for automated content generation and curation.
For regulated companies in industries such as medical technology, pharmaceuticals and biotechnology, the qualification of employees is important: Only those who have demonstrably completed a certain training course are allowed to work in production, cleanrooms, laboratories, etc. And documents such as work instructions play a key role in training: they explain in detail how certain work steps must be carried out.
The goal of RegTechsmart is to generate knowledge modules and training- and knowledge-relevant content through automated solutions and to anchor them broadly in the digitized quality organization. In this way, the level of competence and knowledge can be built up, verified and maintained at an appropriate level in the company through suitable processes of training and knowledge management.
AI-based methods such as text mining, natural language processing (NLP), and machine learning are used: This identifies and extracts training-relevant content in work instructions and converts it into knowledge modules and test questions.
Regulatory compliant document management in the Trial Master File through artificial intelligence
The Trial Master File (TMF) is a collection of documents from a clinical trial; it ensures the integrity of clinical data and compliance to Good Clinical Practice. NextGenTMF develops and tests an innovative eTMF solution using Artificial Intelligence methods and technologies. The focus is on Natural Language Processing (NLP), Machine Learning/Deep Neural Networks and Optical Character Recognition (OCR)/Optical Document Recognition (ODR).
NextGenTMF is a cooperation project of DHC Business Solutions with Averbis GmbH, Freiburg, iOMEDICO AG, Freiburg, and the Chair of Artificial Intelligence and Knowledge Systems at the University of Würzburg. The associated partner is pfm medical AG, Cologne. The project is funded by the German Federal Ministry of Education and Research (BMBF), FKZ 01IS22013A.
valid-AI-te – GxP-compliant computer software validation through Process Automation
The project develops AI-based solutions for (partial) automation of Computer System Validation (CSV). For “Validation Automation” methods of Process Mining, Desktop Activity Mining, Process Automation and Process Prediction are used. The overarching concern is the methodological advancement of CSV as a central element of regulatory compliant software use in key industries through the use of modern AI technologies. CSV should as a result become simpler, more reliable, less expensive and more efficient.
valid-AI-te is funded by the German Federal Ministry of Education and Science (BMBF) within the program “KI4KMU – Research, Development and Utilization of Artificial Intelligence Methods in SMEs” (FKZ 01IS21044A). Project partners are the Junior Professorship for Management Analytics of Professor Dr. Jana-Rebecca Rehse, University of Mannheim, and Ticeba GmbH, Heidelberg.
Regulatory compliance through AI-based environment monitoring in medical technology
SmartVigilance develops technologies and automated processes for the regulatory required post-market surveillance and risk assessment in medical technology. A web-based platform will automatically capture, analyze and report to manufacturers hazardous incidents and product defects reported by users to regulators and which are publicly available. Artificial Intelligence methods and technologies – Natural Language Processing (NLP), Machine Learning (ML), Data Analytics – are used.
SmartVigilance is a cooperative project of DHC Business Solutions with the German Research Center for Artificial Intelligence (Deutsche Forschungszentrum für Künstliche Intelligenz, DFKI), Saarbrücken, and Averbis GmbH, Freiburg. The project is funded by the German Federal Ministry of Education and Research (BMBF), FKZ 01|S20028A.
Blockchain technology for audit trails
The goal of the “GxP Blockchain” project is to prototype blockchain as an innovative,compliant technology option for audit trails and audit trail reviews and to test it in specific application contexts in the GxP environment. Key concerns here are to improve the security and integrity of relevant data, to simplify its auditability, and to expand the possibilities for effective and efficient compliance management within the company.
DHC Business Solutions is working on this project together with the German Research Center for Artificial Intelligence (DFKI) and the medical technology company AkknaTek. The research project “GxP-Blockchain” is scheduled for 20 months and is funded by the Central Technology Program Saar (Zentrale Technologieprogramm Saar, ZTS) and the European Regional Development Fund (ERDF). https://www.saarland.de/132334.htm
Successfully completed projects
Digital compliance management through information logistics
digiComp realizes the prototypical integration of modern technologies for information procurement on the one hand with digital management processes in the GMP environment on the other. The focus is on the question of how digital compliance management in process-oriented manufacturing can be extended to include “information logistics” and what benefits such an extension brings in the context of GMP. “Information logistics” in this context refers to the interplay of efficient methods of on-demand, context-specific, process-integrated and proactive provision of information in real time from distributed data sources and in a cross-organizational context. The project is funded by the European Regional Development Fund (ERDF) as part of the Central Technology Program Saar (ZTS). https://www.saarland.de/132334.htm
Assistance systems for digital SOP and compliance management in GMP-regulated production
The aim of “SOPassist” is to develop a “new generation” of digital, multimedia Standard Operating Procedures (SOPs). These are intended to describe production processes not only textually, but to enhance them with multimedia assets and modern VR/AR and 3D technologies. The instructions prepared in this way can be integrated into GMP-regulated production processes. This is intended to improve knowledge organization in GMP-regulated production processes and to promote GMP-relevant employee qualifications in a production-integrated manner. The result is SOPassist, a web-based service platform for creating multimedia SOPs and an assistance system for the process-integrated, GMP-compliant use of such SOPs in manufacturing companies.
SOPassist is a cooperation project between DHC Business Solutions and neocosmo GmbH and is funded by the European Regional Development Fund (ERDF) as part of the Central Technology Program Saar (ZTS). https://www.saarland.de/132334.htm
RegTech insights: Digitization of Post-Market Surveillance: Ramp-up for the AI service platform SmartVigilance.
Saarbrucken, January 2023: After two years of research and development work, the ramp-up phase for the data platform SmartVigilance is now...
Artificial intelligence makes computer software validation (CSV) easier, more reliable, less expensive and more efficient. This is the...
Today, the development and production of pharmaceutical and medical technology products are no longer conceivable without digital...