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Updates & Assets · GAMP 5 / AI

Updates & Assets for GAMP 5 / AI.

This page is the living shelf for validated assets, weekly signals, revision notes, and future public tools. Nothing here should look published-ready until the source trail and boundary have been checked.

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
/ Asset shelf

Public assets attach only after source validation.

GAMP 5 / AI
Asset 01

GxP impact form

Future asset for GAMP 5 / AI; publish only after source check, date check, boundary review, and revision note.

Asset 02

AI function boundary sheet

Future asset for GAMP 5 / AI; publish only after source check, date check, boundary review, and revision note.

Asset 03

supplier capability checklist

Future asset for GAMP 5 / AI; publish only after source check, date check, boundary review, and revision note.

Asset 04

data integrity checklist

Future asset for GAMP 5 / AI; publish only after source check, date check, boundary review, and revision note.

Asset 05

periodic review worksheet

Future asset for GAMP 5 / AI; publish only after source check, date check, boundary review, and revision note.

/ Watchlist

Updates must show what changed.

revision protocol
Protocol 01

Source revision

Record date, source URL, affected pages, and what interpretation changed.

Protocol 02

Weekly signal

Only promote signals that alter operating decisions, evidence expectations, market movement, or governance work.

Protocol 03

Checklist release

Each checklist needs version, source links, evidence fields, public-safe disclaimer, and review boundary.

Protocol 04

Retirement

Outdated pages should be marked, archived, or redirected without deleting the trace.

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.

open