The Calibration Analogy Doesn't Hold, and That's the Real Problem
Quality teams are borrowing instrument-calibration logic for AI drift, but the metrology underneath doesn't transfer, and that gap is where audits will fail.
Quality teams are borrowing instrument-calibration logic for AI drift, but the metrology underneath doesn't transfer, and that gap is where audits will fail.
AI-driven reanalysis of failed clinical trials is producing new evidence outside the systems built to validate it, and GxP quality frameworks have not caught up.
EASA's admission that atmospheric icing remains insufficiently understood exposes a hidden validation gap for AI-enabled ice detection and anti-icing systems.