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◆   Knowledge hub · GxP-AI

Good AI Practice ( GxP – AI )

From Regulatory Guidance
to Operational Readiness.

In January, FDA and EMA introduced the Good AI Practice framework to guide the development, validation and monitoring of AI systems in regulated environments. Their 10 principles are tailored to the drug development cycle and emphasize the importance of:

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◆   Ch. 01 · The ten principles

Ten principles, tailored
to the drug development cycle.

  1. 01Human-centric by design
  2. 02Risk-based approach
  3. 03Adherence to standards
  4. 04Clear context of use
  5. 05Multidisciplinary expertise
  6. 06Data governance and documentation
  7. 07Model design and development practices
  8. 08Risk-based performance assessment
  9. 09Life cycle management
  10. 10Clear, essential information
◆   Ch. 02 · What it is

What is Good AI Practice?

The Good AI Practice framework defines regulatory expectations for AI systems operating in GxP environments, with a focus on governance, data integrity, lifecycle validation and continuous monitoring.

  • Model governance and accountability
  • Data integrity and traceability
  • Lifecycle validation and continuous monitoring
GAIP framework — stacked layers (Governance · Model · Prompts/Context · Tools/Actions · Policy) under FDA regulatory oversight
Fig. 01 · Governance · Model · Prompts/Context · Tools/Actions · Policy
◆   Ch. 03 · How we help

How InSilicoTrials helps.

From guidance to operational readiness — already with pharma teams.

  • Translate guidance into operational AI governance frameworks
  • Train cross-functional teams (Regulatory, QA, Digital, R&D)
  • Align AI systems with inspection-readiness standards
◆   Ch. 04 · The program

AI Compliance
Readiness
Program.

Designed for executives and non-technical roles. No AI background required.

Track AExecutives & decision-makers

Objectives

  • Understand regulatory intent
  • Identify compliance risks
  • Set up governance processes
Track BCross-functional teams

Objectives

  • Interpret validation documents
  • Ask the right questions
  • Support audit preparedness
◆   Ch. 05 · Get in touch

Receive more
information.

Get the program outline and executive briefing materials.

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Aligned with FDA and EMA guidelines
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