· Amit Kothari
· AI Workflows and Operations
AI in pharma - what GxP requires of your workflows
GxP rules demand that every record touching product quality or patient safety be ALCOA+ - attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available. Most AI agents do not meet that bar by default. The fix maps cleanly onto workflow execution, with a qualified human signing every consequential step.