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AI Governance · GAMP 5 / AI

AI Governance for GAMP 5 / AI.

This page focuses on AI governance implications inside regulated work. It shows where AI changes evidence needs while keeping quality, regulatory, data, supplier, and human accountability controls in view.

Source basis: GAMP 5 guidance and regulated computerized-system validation contextUse: evidence-readinessBoundary: not legal advice
GAMP 5 / AI TRACE ISPE GAMP 5 SOURCEEU GMP ANNEX 11EUDRALEX VOLUME PIC/S COMPUTERIZ
/ AI governance

AI changes the evidence pattern, not the need for control.

GAMP 5 / AI
Control 01

Model boundary

State what the model does, what it does not do, and which regulated process it touches.

Control 02

Data integrity

Input, output, audit trail, access, retention, and review must remain trustworthy.

Control 03

Supplier leverage

Vendor evidence can support but not replace internal accountability.

Control 04

Periodic review

AI behaviour, data drift, and system performance should feed continued suitability review.

/ Adjacent controls

AI governance must connect to existing regulated systems.

not isolated
Evidence 01

GxP impact assessment

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 02

User requirement set

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 03

Supplier assessment

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 04

Risk and criticality assessment

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 05

Validation/assurance plan

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 06

Configuration specification

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

/ Source anchors

Current public sources for GAMP 5 / AI.

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official source page / paid guidance

ISPE GAMP 5 official publication page

Current · Source-owner page for GAMP 5. Public pages must not reproduce protected guidance content.

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Official EU GMP source page

European Commission EudraLex Volume 4

Current · Official page for EU GMP chapters and annexes, including computerized-system context such as Annex 11.

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Official EU GMP annex

EU GMP Annex 11 Computerised Systems

2011-06-30 · Public EU GMP source for computerized systems in GMP contexts.

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