valid-AI-te – GxP-compliant Computer Software Validation by Process Automation

Sectors such as the pharmaceutical industry, biotechnology or medical technology are subject to strict health authority regulations and special requirements for the use of IT systems in order to ensure the safety of people and products. These requirements are risky, error-prone and generate high costs. Regulated companies – especially SMEs – therefore often try to avoid software changes and modernisations. This endangers IT compliance, which can lead to the suspension of business operations by official order. 

The goal of “valid-AI-te” is to prototype and test AI- or AI-based solutions for the (partial) automation of CSV (Validation Automation). Through valid-AI-te, CSV as a core requirement for regulated industries will become simpler, more reliable, cheaper and more efficient. This is achieved by adapting and further developing methods from the fields of process mining, desktop activity mining, process automation and process prediction. 

“valid-AI-te” is a cooperation project between the Management Analytics Center (MAC) and the Junior Professorship for Management Analytics at the University of Mannheim as well as DHC Business Solutions GmbH & Co. KG as development partner and Ticeba GmbH, Aenova Group and WALA Heilmittel GmbH as application partners.

Business processes often have to follow specific prescribed regulations, such as clinical practice guidelines in healthcare, laws and statutes in public administration, and – especially since the beginning of the pandemic – hygiene rules in many different domains. 

The project „Combining Process Mining and Reference Models for Improving Daily Practices and Regulations – Conformance Checking with Regulations (CheR)“ combines, for the first time, techniques from reference modeling and conformance checking to compare real-life process behavior with prescribed regulations. The goal is to find and visualize the deviations between them to allow tailored training for employees, preparation of audits, or suggestions for improving either the process or the regulations in the respective domains.

“Conformance Checking with Regulations (CheR)” is a cooperation project between Prof. Dr. Jana Rehse, Junior Professor for Management Analytics at the University of Mannheim, and Dr. Luise Pufahl, Postdoctoral Researcher at the Chair of Software and Business Engineering at the TU Berlin, funded by the German Research Foundation (DFG). The project is hosted by the Institute of Enterprise Systems (InES) at the University of Mannheim and the Management Analytics Center (MAC) of the Faculty of Business Administration.