Regulations/Good AI Practice/Evidence Readiness
Evidence Readiness · Good AI Practice

Evidence Readiness for Good AI Practice.

This page converts regulatory reading into evidence-readiness. It defines the records, owners, review questions, and trace fields that make a future checklist or readiness review defensible.

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
Evidence objects

Readiness becomes visible through records.

Good AI Practice
Evidence 01

AI use-case statement

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 02

Context-of-use record

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 03

Data provenance file

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 04

Bias/representativeness review

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 05

Model development record

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 06

Validation protocol and report

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 07

Human review boundary

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 08

Transparency statement

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 09

Monitoring plan

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Evidence 10

Change and retirement record

Keep this as a named evidence object for Good AI Practice: source basis, owner, status, review question, and update trigger should be visible before reuse.

Readiness questions

Each object needs review before reuse.

question bank
Question 01

AI use-case statement

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 02

Context-of-use record

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 03

Data provenance file

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 04

Bias/representativeness review

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 05

Model development record

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 06

Validation protocol and report

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 07

Human review boundary

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?

Question 08

Transparency statement

Ask: who owns it, what source does it trace to, what evidence exists, what is missing, and what should not be claimed?