AI Validation

Validating AI Systems, a Guide for Compliance Leaders

What compliance leaders need to know about validating AI and machine learning systems used in GxP regulated decisions.

Who Owns Validation When an AI Vendor Updates Its Model

A plain look at who is accountable when an AI vendor retrains or updates the model behind a tool used in a GxP process.

AI Copilots in Regulated Workflows, the Questions to Ask

The compliance questions to ask before letting an AI copilot touch a regulated document or workflow.

Validating AI Workflows During Build, Not After

The case for building traceability and validation evidence into an AI workflow as it is developed, instead of reconstructing it afterward.

Does the Validation Tool Itself Need Validation

Whether a computer system validation platform needs to be validated itself, and what a compliance leader should ask to check.