Aide Mémoire 07121202 der ZLG (Annex 11): Überwachung computergestützter Systeme

Die ZLG hat nun das angekündigte Aide Memoire bzgl. EU GMP Leitfaden – Anhang 11 veröffentlicht.

The German ZLG has published the Inspection Aide Memoire based on EU GMP Annex 11. The current version is available in German language only.

 

Download AIDE MEMOIRE – Annex 11 (German): ZLG_AM_QS_07121202

Basis: EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines

UPDATE: Please find here the English translation of the Aide Memoire.