AI does not replace validation. It makes it intelligent.
In ISPE Pharmaceutical Engineering (January/February 2026), Oliver Herrmann and Frank Henrichmann (QFINITY) show how AI is changing the validation of computerized systems, and what its benefits depend on: well-documented processes, precise requirements and structured risk assessments.
AI makes validation intelligent, not obsolete.
Validating computerized systems remains a regulatory cornerstone. At the same time, it is resource-intensive and error-prone. The article frames its forecast as conditional: AI can support requirements interpretation, test creation and execution, evidence capture and risk assessment, but its benefit is tied strictly to the quality of the inputs, not to a promise of automation.
The key points at a glance.
From document administrator to Quality Architect.
When AI takes over script creation, test execution and document administration, the work of validation teams shifts away from mechanics toward judgment. That work includes business analysis, quality assurance of the inputs and approval of AI outputs. That shift comes with greater responsibility: the purpose of a validation comes from the process and its intended use, not from the tool. The AI supplies suggestions; judging their suitability remains a human decision.
This is exactly where QFINITY operates, in the middle of each of these shifts, and it helps shape them through the leading organizations (ISPE, RQA, ACDM). For us, AI is not hype but the necessary next step: it is here to stay, and it will change fast. Rigor scaled to process understanding and risk, not to what a tool promises.
Guardrails still taking shape.
Guidance is still limited: the Annex 22 draft would exclude generative AI and LLMs from critical GMP applications; for non-critical applications they remain an option, with a qualified human-in-the-loop. The draft leaves the classification methodology open; we recommend a documented risk assessment. On top of that, the AI itself must be verified (reliability, defined limits, consistency), and ICH Q9(R1) reminds us to deliberately address subjectivity and bias in risk management.
Written by GAMP practitioners.
Frank Henrichmann, Senior Executive Consultant at QFINITY, is Chair of the GAMP Global Steering Committee and a member of the global GAMP AI SIG. Oliver Herrmann, founder and CEO of QFINITY, is Chair of the ISPE GAMP Europe Steering Committee, a member of the ISPE AI Community of Practice and GAMP Track Lead of the ISPE Europe Conference 2026 in Copenhagen. Both are among the small group of qualified ISPE GAMP trainers. The article is their own publication, not a third-party article about QFINITY.
From thesis to lived practice.
AI in validation, but on a sound foundation.
We work with you to determine whether processes, requirements and risk assessments are robust enough for AI-supported validation to deliver traceable, evidenced results. Free initial consultation, about 30 minutes, directly with one of the authors.
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