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Source Library · GAMP 5 / AI

Source Library for GAMP 5 / AI.

This source library keeps official references, implementation status, and public-use boundaries visible for the workspace. It supports evidence-readiness without turning protected standards, guidance, or legal material into loose checklist language.

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
/ Official shelf

Source library for GAMP 5 / AI.

verified anchors
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.

open
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.

open
Official EU GMP annex

EU GMP Annex 11 Computerised Systems

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

open
/ Source discipline

What can be used publicly and what must stay bounded.

public-safe
Rule 01

Official source first

Use regulator, source-owner, EUR-Lex, FDA, EMA, ICH, ISO/IEC, ISPE, IMDRF, Health Canada, MHRA or similar authority/source-owner pages before commentary.

Rule 02

Paid-source boundary

Where a standard or guide is protected, the page names the source and describes public-safe implications without reproducing protected clause text.

Rule 03

Status visible

Every source needs date/status language so draft, final, watch item, and effective/applicable dates are not mixed.

Rule 04

Interpretation separated

Source fact and iFeed interpretation must remain visibly separated before any checklist is published.

/ Source objects

Objects that deserve stable child pages.

future expansion
Object 01

ISPE GAMP 5 source page

Source-owner link only; protected guide content must not be reproduced.

Object 02

EU GMP Annex 11

Public GMP computerized-systems source anchor.

Object 03

EudraLex Volume 4

Official EU GMP source hub for related chapters and annexes.

Object 04

PIC/S computerized systems guidance

Public comparator source for computerized-system expectations.

Object 05

FDA CSA as adjacent source

Useful for risk-based assurance comparison in device QMS software.

Object 06

AI guide boundary

ISPE AI guidance is protected; use public metadata and public-safe interpretation only.