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Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years and is a national key high-tech enterprise and a national technology innovation demonstration enterprise

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The warning letter reaffirms that existing law governs AI just as any other tool : all quality-affecting documents and decisions must be reviewed and approved by competent humans in the Quality Unit (21 CFR 211.22), and statutory requirements (like process validation) cannot be bypassed by blaming an AI system ( [2] ) ( [3] )

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