Posted On: Apr 28, 2021

AWS Audit Manager now offers a new prebuilt standard framework for GxP EU Annex 11. This framework adds to the existing prebuilt frameworks provided in Audit Manager. With this release, you can launch an assessment from this framework with just a few clicks. Audit Manager will map your AWS resources to the requirements in GxP EU Annex 11 and start gathering evidence automatically to help you scale your audit capability in the cloud as your business grows.

The GxP EU Annex 11 is part of the European Good Manufacturing Practices (GMP) guidelines and defines the terms of reference for computerized systems that are used by organizations in the pharmaceutical industry. Essentially, GxP EU Annex 11 is a checklist that enables the European regulatory agencies to establish the requirements for computerized systems that relate to pharmaceutical products and medical devices. This framework is the European equivalent to FDA 21 CFR part 11 for the United States. Audit Manager provides 19 automated controls and 13 manual controls for this framework. These controls offered by Audit Manager do not guarantee that you will pass a GxP assessment but instead help reduce effort and time in your GxP review preparation.

This release is now available in all AWS Regions where AWS Audit Manager is offered. To learn more, see the GxP EU Annex 11 in the AWS Audit Manager documentation.