The flow moves from source to reviewable work.
GAMP 5 / AIRecommended operating sequence.
Define GxP process · Assess intended use and impact · Map supplier dependency · Plan lifecycle evidence · Verify critical functions · Control data and access · Review changes and performance
Where teams usually lose traceability.
audit watchSource skipped
Using a blog summary instead of the official source creates weak claims.
Role unclear
Provider, deployer, sponsor, manufacturer, vendor, or owner responsibilities blur.
Evidence not owned
A document exists but nobody owns review, update, or closure.
Change not logged
Model, system, SOP, source, or guidance changes do not reach the evidence file.
Current public sources for GAMP 5 / AI.
official firstThese links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.
ISPE GAMP 5 official publication page
Current · Source-owner page for GAMP 5. Public pages must not reproduce protected guidance content.
European Commission EudraLex Volume 4
Current · Official page for EU GMP chapters and annexes, including computerized-system context such as Annex 11.
EU GMP Annex 11 Computerised Systems
2011-06-30 · Public EU GMP source for computerized systems in GMP contexts.