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ISPE · GAMP Guide: Artificial Intelligence
The GxP validation framework for AI systems.
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Citation: ISPE GAMP Guide, Artificial Intelligence, July 2025
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What to do about it
Keep the evidence this asks for, as the work happens.
A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer™. It runs inside your own environment and nothing has to leave it.
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What the guide covers, and what it does not reach
ISPE, GAMP Guide: Artificial Intelligence, published July 2025. The first consolidated GxP validation framework for AI, and the document inspectors are most likely to assume fluency in. Its subject matter includes:
- Risk tiering of AI systems
- Controls scale with the risk the system carries, in the established GAMP manner.
- Drift monitoring
- Ongoing monitoring of model behaviour after the system is in use.
- Retraining under change control
- A retrained model is a change, and is handled through the change-control system rather than silently.
- Life-cycle controls, which is the boundary
- The guide addresses the life cycle of the system. It does not describe a check, at the moment of a consequential action, that the action is still authorised by the human decision then in force. That gap is analysis rather than criticism: the two things answer different questions.
This is a guidance document from a standards body, not law. Its full text is available from ISPE under its own terms. Nothing here makes any system validated: validation is a life-cycle activity carried out on the system itself by the regulated company.
Built against the publisher’s description of the primary text. Verified 17 August 2026.
This is the duty on the business. For what a lawyer in Europe must disclose about using AI in a filing, see Europe: the EU AI Act, the CCBE guides, and what Germany tells its lawyers.