AI application validation series

Assessing and Validating AI Applications in Quality Systems

A practitioner series for defining, assessing, testing, releasing, and maintaining AI applications used in Quality and regulated processes.

Series method

Begin with the work, not the model

  1. Define the decision.State what work changes and what could be affected by an incorrect or incomplete result.
  2. Draw the application boundary.Include information sources, processing components, interfaces, people, outputs, and connected systems.
  3. Keep authority explicit.Separate generated information from review responsibility, final decisions, and permitted actions.

Published chapters

Start with intended use

Chapter 1 establishes the scope needed for later risk assessment, requirements, testing, release, and monitoring decisions.

Foundation · 18 minutes

Define the AI Application and Its Intended Use

Define the application boundary, permitted functions, operating conditions, human responsibilities, exclusions, and reassessment triggers before risk assessment or testing begins.

  • Four original application and workflow diagrams
  • Supplier-assessment and validation-record examples
  • Practice exercise with a suggested answer
Read the complete chapter