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Actors & Services · GAMP 5 / AI

Actors & Services for GAMP 5 / AI.

This page maps the people and service routes around the regulation. It shows who needs which evidence view and where iFeed can support review, translation, training, or readiness work without overclaiming.

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
/ Actors

Different owners need different evidence views.

GAMP 5 / AI
Actor 01

validation lead

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

Actor 02

QA

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

Actor 03

IT/system owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

Actor 04

process owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

Actor 05

supplier quality

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

Actor 06

data integrity owner

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

Actor 07

automation engineer

This actor needs a clear route from source interpretation to owned evidence, decision, and follow-up for GAMP 5 / AI.

/ Service fit

Where iFeed can help without overclaiming.

bridge work
Route 01

Source-to-evidence mapping

Convert source material into evidence objects, owners, gaps, and next actions.

Route 02

Checklist evaluation

Review completed readiness sheets and identify unclear or unsupported claims.

Route 03

Governance sprint

Create a practical two-week route for inventory, role mapping, evidence review, and update protocol.

Route 04

Training/workshop

Turn source reading into role-specific literacy and operational confidence.

/ 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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