To obtain the latest version of the official guide, please visit https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf.

Overview

EU Annex 11 is the European equivalent to FDA 21 CFR part 11 for the United States. This annex applies to all forms of computerized systems used as part of a GMP regulated activities. A computerized system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated; IT infrastructure should be qualified. Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.