GxP EU Annex 11 - AWS Audit Manager

GxP EU Annex 11

To assist you with your audit preparation, AWS Audit Manager provides a prebuilt framework that supports GxP EU Annex 11 regulations that are based on AWS best practices.

Note

For information about GxP 21 CFR Part 11 and the Audit Manager framework that supports it, see GxP 21 CFR part 11.

What is GxP EU Annex 11?

The GxP EU Annex 11 framework is the European equivalent to the FDA 21 CFR part 11 framework in the United States. This annex applies to all forms of computerized systems that are used as part of Good Manufacturing Practices (GMP) regulated activities. A computerized system is a set of software and hardware components that together fulfill certain functionalities. The application should be validated and 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.

Annex 11 is part of the European GMP guidelines and defines the terms of reference for computerized systems that are used by organizations in the pharmaceutical industry. Annex 11 functions as a checklist that enables the European regulatory agencies to establish the requirements for computerized systems that relate to pharmaceutical products and medical devices. The guidelines set forth by the Commission of the European Committees aren't that much distant from the FDA (21 CFR Part 11). Annex 11 defines the criteria for how electronic records and electronic signatures are considered to be managed.

Use AWS Audit Manager with the GxP EU Annex 11 framework

You can use The GxP EU Annex 11 framework in AWS Audit Manager to prepare for audits that are associated with this framework. It contains 19 automated controls and 13 manual controls. The controls in this framework aren't intended to verify whether your systems are compliant with the GxP EU Annex 11 requirements. Moreover, they can't guarantee that you will pass a GxP EU Annex 11 assessment. AWS Audit Manager doesn't automatically check procedural controls that require manual evidence collection.

You can find the GxP EU Annex 11 framework under the Standard frameworks tab of the Framework library in Audit Manager.

For instructions on how to create an assessment using this framework, see Creating an assessment. For instructions on how to customize this framework to support your specific requirements, see Customizing an existing framework and Customizing an existing control.