PIC/S PI 011-3 and its 1 linked instrument

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	PIC/S PI 011-3	PIC/S GMP Guide PE 009
Authority	PIC/S	PIC/S
Legal weight	Guidance & Q&A	GMP guide & annexes
Status	Final	In force
Last verified	Not yet	Not yet
Summary	PIC/S guidance giving inspectors recommendations and background on computerised systems, for training and for use during inspections. It supports the PIC/S GMP Guide and its Annex 11 and is written for all good practice inspectors in the regulated pharmaceutical sector. Link only.	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.
Lifecycle	1 Sep 2003 Entered into force 25 Sep 2007 Version PI 011-3 dated 25 Sep 2007	23 Sep 2026 PE 009-18 published (revised Annex 19, reference and retention samples); supersedes PE 009-17
Source	Official text Summary in our own words. See the official text from PIC/S.	Official text Summary in our own words. See the official text from PIC/S.

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.