Frank Henrichmann

QFINITY
Senior Executive Consultant
Frank Henrichmann, Senior Executive Consultant at Q-FINITY Quality Management, is an expert in quality management, computer system validation, and compliance, especially in the context of clinical trials and pharmacovigilance. Over more than 22 years, he has gained extensive experience in strategies, projects, and measures for GxP-regulated environments at a CRO as well as a major pharmaceutical company. In his current position, he helps life sciences companies and supports technology providers to find innovative answers to quality and validation challenges. Frank is a member of the Clinical Systems Special Interest Group (SIG) and is a coauthor of the GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data. He has been an ISPE member since 2001 and currently is the Co-Chair of the GAMP Global Steering Committee.

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.