Mr. Oliver HERRMANN

Oliver has a degree in applied computer science and is also an ISACA CDPSE Certified Data Privacy Solutions Engineer, Certified SAFe Agile Practitioner, and Microsoft Certified Systems Engineer (MCSE). Oliver is the managing director of QFINITY, which he founded in 2004 with the vision to combine process management with the requirements for the Validation of computerized Systems and to offer this package as part of an integrated service portfolio. QFINITY provides services to companies that must comply with regulations in Asia, Europe, and/or the United States. Oliver has been significantly involved in the planning, development, execution, and auditing of strategies, projects, activities, and procedures for GxP-regulated environments for 20 years. His expertise encompasses the full spectrum of methods, principles, and software tools used in the pharmaceutical and medical device industries, from simple spreadsheets, pharmacovigilance solutions, laboratory information management systems, production-related systems, and automation and distribution systems to global ERP systems and IT Infrastructures. His experience has made him a much sought-after presenter for industry events all over the world. Oliver also contributes to the development of industry-wide best practices by volunteering with the ISPE. As an example, in 2009, he started an ISPE GAMP Special Interest Group (SIG) to demonstrate the application of and promote the acceptance and awareness of current Good Automated Manufacturing Practices (GAMP) in the GCP area. In December 2018, the ISPE released their work as the official GAMP Good Practice Guide “Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice”. In the context of the GAMP 5 2nd Edition revision, he was a member of the Extended Core Team. Oliver's current interests revolve around enabling innovation in the GxP-environment, including GxP-compliant approaches to agile development, SaaS software models, platform technologies (incl. PaaS) and their validation and implementation. Active projects in this area include supporting an SAP S/4HANA implementation (HEC) with MES and LIMS integration.