Insights
Articles on AI validation, computerized systems assurance, and technology quality for senior quality and technology leaders in regulated industries.
Human oversight depends on what a person can understand, verify, and change. Technology, access to evidence, education, training, time, and organizational support determine whether a review protects the decision or merely records an approval.
Read the articleAn AI workflow can accurately report human oversight and still run a consequential path no person ever looks at. A branch-level way to audit that claim, worked through hiring and clinical-trial pre-screening.
Read the articleTraditional computerized systems validation and AI validation pursue the same outcome: a system that is fit for its intended use and remains under control. The difference lies in the evidence needed to support that conclusion.
Read the articleBring this into your program
Begin with a focused discussion about context, risk, evidence, and the outcome you need.
