Hilke Nentwich is a seasoned business analysis and risk-based computer system validation professional with over 15 years of experience. She specializes in regulated industries such as Clinical Trial Management Systems, patient safety and regulatory reporting, monitoring systems for sleep trials, and Laboratory Information Management Systems (LIMS). With a DPhil and MBiochem from the University of Oxford and experience in software design and development using various technologies such as C#, VB.Net, SQL, XML, HL7, HTML/CSS, and ASP.NET, Hilke has the expertise to interact with internal and external stakeholders at all levels. She also excels at business process analysis, development, and optimization, requirements elicitation and analysis, change and risk management, project management, user training, and external and internal audits including supplier audits. In her most recent role as Senior Specialist, Requirements Engineering at Technolas Perfect Vision GmbH, Hilke has continued to demonstrate her prowess in Agile delivery, risk-based computer system validation strategy, and software development using OOP principles. Overall, Hilke Nentwich's experience and expertise make her a force to be reckoned with in the business analysis and risk-based computer system validation field.