Although 80% of the work is documentation and only 20% is actual testing, findings still emerge during audits. Traditional computer software validation (CSV) was designed for stable systems and long release cycles. However, the cloud, software as a service (SaaS), and frequent updates have fundamentally changed the IT landscape in medical technology. Systems change faster than evidence can be generated. Compliance hinders delivery, and revalidations delay releases.
The way forward is outlined in regulations. The FDA CSA Guidance and the second edition of GAMP 5 mark a paradigm shift away from document-driven validation and toward evidence-based computer software assurance (CSA). In this 20-minute webinar, Torsten Herbert will demonstrate how to methodically navigate this transition and explain how the SEEK method translates CSA into a practical operating model. He will also discuss the role AI can play as a validation assistant.
IT directors, CTOs, regulatory affairs managers, QA directors, and R&D vice presidents at medical technology companies.
Torsten Herbert, Quality Engineer and Team Leader at sepp.med
Date: April 28, 2026, 11:00 a.m.Duration: 20 minutes + Q&A
Sign up for this free webinar to learn how to modernize validation without compromising audit robustness. Register now!
Torsten Herbert studied physics at the Justus Liebig University in Giessen, specializing in applied physics - sensor technology.
After gaining more than eleven years of practical experience as a software developer in various industries, he joined sepp.med in 2006 in the field of software quality assurance and is now team leader.
He has multiple certifications, including CTFL, CTFL-AuT and CTAL TM, and has extensive experience as an IT consultant, project manager and test manager.
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