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Applicability · GAMP 5 / AI

Applicability for GAMP 5 / AI.

This page turns scope and timing into a decision route. It separates who is in scope, what trigger applies, which date matters, and where teams should avoid premature compliance claims.

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
/ Applicability logic

Applicability begins with scope, not assumption.

GAMP 5 / AI
Applicability 01

GxP computerized systems

Systems supporting GMP, GCP, GLP, PV, or regulated quality decisions.

Applicability 02

AI-enabled functions

AI is relevant when model output affects regulated records, product quality, patient safety, or decisions.

Applicability 03

Non-GxP business AI

Should not be presented as GAMP validation work unless it affects regulated processes.

Applicability 04

Supplier systems

Cloud/SaaS/vendor dependencies need supplier evidence and responsibility clarity.

/ Dates and gates

Timing changes what can be responsibly claimed.

status gates
Gates

Track these before publishing a checklist or readiness claim.

2022 GAMP 5 second edition public status · 2011 Annex 11 public anchor · 2025 ISPE AI guide watch/source boundary · system go-live · configuration/model/data change · periodic review

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/ Use cases

Regulated use cases need a decision record.

life sciences lens
Use case 01

Intended use and GxP impact

Use this as a trigger for GAMP 5 / AI applicability review, not as an automatic compliance conclusion. Validation depth follows use, patient/product impact, and regulated process dependency.

Use case 02

System lifecycle

Use this as a trigger for GAMP 5 / AI applicability review, not as an automatic compliance conclusion. Evidence planning covers selection, design/configuration, verification, operation, change, and retirement.

Use case 03

Supplier assessment

Use this as a trigger for GAMP 5 / AI applicability review, not as an automatic compliance conclusion. Vendor capability and outsourced responsibilities need documented review.

Use case 04

Data integrity

Use this as a trigger for GAMP 5 / AI applicability review, not as an automatic compliance conclusion. ALCOA+ style concerns appear in records, audit trails, access, and retention.

Use case 05

AI model behaviour

Use this as a trigger for GAMP 5 / AI applicability review, not as an automatic compliance conclusion. AI-enabled functions need boundaries, monitoring, and human review where needed.

Use case 06

Paid-source boundary

Use this as a trigger for GAMP 5 / AI applicability review, not as an automatic compliance conclusion. GAMP 5 can be linked and interpreted at a public-safe level, but protected guide content must not be reproduced.

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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