The new Guide provides a holistic framework for developing and using AI in GxP regulated areas. "To date, no singular source of comprehensive guidance for use of AI has been available for the ...
While 21 CFR Part 11 guidelines on electronic records and electronic signatures remain under review with the ultimate goal of revision, consider the ISPE's GAMP guidance a source of support. GAMP 5 ...
The International Society for Pharmaceutical Engineering (ISPE) has announced its keynote speakers for the 2026 ISPE AI in Life ...
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