Source Library · Good AI Practice

Source Library for Good AI Practice.

This source library keeps official references, implementation status, and public-use boundaries visible for the workspace. It supports evidence-readiness without turning protected standards, guidance, or legal material into loose checklist language.

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
/ Source discipline

What can be used publicly and what must stay bounded.

public-safe
Rule 01

Official source first

Use regulator, source-owner, EUR-Lex, FDA, EMA, ICH, ISO/IEC, ISPE, IMDRF, Health Canada, MHRA or similar authority/source-owner pages before commentary.

Rule 02

Paid-source boundary

Where a standard or guide is protected, the page names the source and describes public-safe implications without reproducing protected clause text.

Rule 03

Status visible

Every source needs date/status language so draft, final, watch item, and effective/applicable dates are not mixed.

Rule 04

Interpretation separated

Source fact and iFeed interpretation must remain visibly separated before any checklist is published.

/ Source objects

Objects that deserve stable child pages.

future expansion
Object 01

FDA/EMA Good AI Practice principles

Common principles for AI in drug development released in January 2026.

Object 02

EMA/HMA AI lifecycle reflection

Medicinal-product lifecycle context for AI use and risk management.

Object 03

FDA AI drug development page

US source hub for AI in drug-development activity.

Object 04

GMLP medical-device principles

Comparator source for device ML development; separate from medicines AI.

Object 05

Context-of-use principle

The same model can carry different risk depending on decision context.

Object 06

Lifecycle management principle

Model performance, change, and monitoring remain active after deployment.