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

‐ Apr 26, 2022 4:10pm

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.