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2022 ISPE Europe Annual Conference

EU22CEAPR1/SES304 - AI Maturity Model for GxP Application - Setting the Foundation for the Validation of AI

Apr 26, 2022 4:30pm ‐ Apr 26, 2022 5:10pm


Artificial Intelligence (AI) becomes increasingly important to the GxP-regulated areas of the pharmaceutical industry, while the validation of these systems remains uncertain. The classical method of selecting a GAMP category to identify the appropriate computerized system validation (CSV) approach can only be applied to validate the AI infrastructure. However, it does not provide guidance for validating a software system applying trained AI-algorithms. We developed a maturity model builds the missing foundation for an AI validation concept.


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