Almost simultaneously, the regulatory requirements for computerized system validation in Europe (Annex 11 and 22 of the EU GMP Guidelines) and North America (Computer Software Assurance (CSA) Guide) were updated.
The fast changes in software systems in terms of updates, patches, new functionalities, and the expansion of technology through cloud computing and artificial intelligence made these adjustments necessary.
Since then, the term CSA has become increasingly prominent. But what exactly does CSA mean and how does it differ from the CSV used so far? What do you need to consider now when validating your computer-based systems?
In the webinar on “CSV versus CSA”, Dr. Carsten Börger, Senior GMP Consultant at Valicare GmbH, provides an overview about the risk-based approach to computer-based validation and what else needs to be considered regarding CSA.
The following topics will be covered during the webinar:
✅Fundamentals of risk-based CSV based on GAMP®5
✅Introduction & definition
✅Requirements
✅Validation using AI based on EU-GMP, Annexes 11 & 22
✅CSA: What needs to be considered?
✅Q&A
Who from the pharmaceutical industry should participate?
✅All positions relevant to CSV in the areas of:
✅IT department
✅Quality assurance
✅Engineering, manufacturing, and quality control
✅Software development and integration
Our webinar will be held in German and English and will take place on the following dates:
Please select your preferred date:
December 9, 2025 | 3:30-5:00 PM (UTC+1) | German
January 16, 2026 | 1:30-3:00 PM (UTC+1) | English
🔎 Keep yourself informed about CSV versus CSA at an early stage. The next validation is sure to come!
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