Dashboard: GxP EU Annex 11

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.


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.


Browse dashboards and select GxP EU Annex 11:

steampipe dashboard

Or snapshot and share results via Steampipe Cloud:

steampipe login
steampipe dashboard --share aws_compliance.benchmark.gxp_eu_annex_11


This dashboard is automatically generated from the following benchmark: