Expert Article published in Pharmaceutical Engineering

expert articleOur expert article “How AI Will Transform Computerized System Validation” has been published in the latest issue of Pharmaceutical Engineering, the journal of the International Society for Pharmaceutical Engineering (ISPE).

In this article, Oliver Herrmann and Frank Henrichmann of QFINITY demonstrate how artificial intelligence can fundamentally transform Computerized System Validation (CSV) in regulated GxP environments — from requirements definition and risk assessment to test creation and execution.

Key message:


AI accelerates CSV not by replacing expertise, but by purposefully supporting it. Based on clearly defined business processes, AI analyzes relevant inputs and helps generate precise user requirements, structured risk assessments, and robust test cases. Using a human-in-the-loop approach, qualified AI tools can simultaneously increase the speed, consistency, and quality of validation deliverables.

The article also addresses:

  • the evolution of roles within validation teams (from document management to quality architecture),

  • the regulatory guardrails that must be considered when using AI,

  • and key challenges such as regulatory acceptance, qualification of AI systems, and change management.

We would like to thank ISPE for providing the platform and for initiating this important discussion.