The appropriate use depends on the level of regulatory maturity and human oversight. Established applications include tools supporting process monitoring, continued process verification, laboratory or manufacturing data management, and controlled electronic records. Emerging uses include AI-assisted Module 3 gap analysis, stability modeling, and batch-record review, provided outputs are verified by qualified personnel and the underlying data and systems are controlled. Fully autonomous regulatory conclusions or batch-release decisions remain far more difficult to justify. AI should support accountable expert judgment, not replace required human review or quality-unit responsibility.
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