Compare PIC/S GMP Guide PE 009 and Annex 11 (2011)

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How they are linked says why these two documents are connected. Links explained
Side by side places facts from each record together, so you can see status, weight and dates at a glance.
It does not compare content. It does not say which is stricter. Read the official texts for that.

Details: Guide Definitions: every term and label explained

How they are linked

PIC/S GMP Guide PE 009 is the counterpart of Annex 11 (2011) · Source Unverified link

Side by side

	PIC/S GMP Guide PE 009	Annex 11 (2011)
Authority	PIC/S	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes
Status	In force	In force
Last verified	Not yet	Not yet
Summary	The PIC/S GMP guide used by participating inspectorates, including an annex on computerised systems equivalent to EU Annex 11. PIC/S co-drafts the current EU revisions.	The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation.
Lifecycle	23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation
Source	Official text Summary in our own words. See the official text from PIC/S.	Official text Source: European Commission. Licensed under CC BY 4.0.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.