Thinking on Regulated Digital Transformation

Generation Without Judgement: Agentic AI in the GxP Lifecycle

Agentic AI can draft validation documentation, generate test suites, and accelerate the build of GxP software by an order of magnitude. None of that helps if an auditor cannot trust how the artefacts were produced. After a year of building this way — a coding agent beside my editor, drafting test cases and traceability rows under review — I have come to think the change is not what most teams expect. It is not that AI helps with validation. It is that AI shifts where critical thinking has to live.