Regulations/Good AI Practice/Operational Flow
Operational Flow · Good AI Practice

Operational Flow for Good AI Practice.

This page describes the operating route from source text to practical use. It maps handoffs, gates, failure points, and review moments so the work can move without losing traceability.

Source basis: Guiding principles for Good AI Practice in drug development and related lifecycle guidanceUse: evidence-readinessBoundary: not legal advice
Good AI Practice TRACE FDA/EMA GOOD AI PREMA/HMA AI LIFECFDA AI DRUG DEVEGMLP MEDICAL-DEV
/ Operational route

The flow moves from source to reviewable work.

Good AI Practice
Flow

Recommended operating sequence.

Frame AI use case · Map decision impact · Assess data suitability · Validate model performance · Set human review · Monitor lifecycle · Prepare regulator-facing explanation

07
/ Failure points

Where teams usually lose traceability.

audit watch
Risk 01

Source skipped

Using a blog summary instead of the official source creates weak claims.

Risk 02

Role unclear

Provider, deployer, sponsor, manufacturer, vendor, or owner responsibilities blur.

Risk 03

Evidence not owned

A document exists but nobody owns review, update, or closure.

Risk 04

Change not logged

Model, system, SOP, source, or guidance changes do not reach the evidence file.