Oliver Herrmann

Q-FINITY Quality Management
Managing Director
Oliver Herrmann is 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. Oliver has been significantly involved in the planning, development, execution, and auditing of strategies, projects, activities, and procedures for GxP-regulated environments for more than 20 years. His expertise encompasses the full spectrum of methods, principles, and software tools used in the pharmaceutical and medical device industries. He has a degree in applied computer science and is an ISACA-Certified Data Privacy Solutions Engineer, a Certified Scaled Agile Framework Practitioner, and a Microsoft-Certified Systems Engineer. His experience has made him a much sought-after presenter for industry events all over the world. He has been an ISPE member since 2002.

Related Articles

Quality Considerations in Disaster Recovery: A Case Study
Features
Quality Considerations in Disaster Recovery: A Case Study

Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...

Best Practices for Deploying Real-World Evidence Solutions
Features
Best Practices for Deploying Real-World Evidence Solutions

Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.1

  • 1US Food and Drug Administration. “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Guidance for Industry and Food...
Validation of Clinical Trial–Related Systems in Smaller Enterprises
Features
Validation of Clinical Trial–Related Systems in Smaller Enterprises

Existing risk-based approaches to computerized system compliance and validation as outlined in GAMP® 51  are applicable to a variety of life sciences organizations...

  • 1International Society for Pharmaceutical Engineering. GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2008.