GxP 21 CFR part 11 - AWS Audit Manager

GxP 21 CFR part 11

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

Note

For information about GxP EU Annex 11 and the Audit Manager framework that supports it, see GxP EU Annex 11.

What is GxP CFR part 11?

GxP refers to the regulations and guidelines that are applicable to life sciences organizations that make food and medical products. Medical products that fall under this include medicines, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers. It's also to ensure the integrity of data that's used to make product-related safety decisions.

The term GxP encompasses a broad range of compliance-related activities. These include Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Good Manufacturing Practices (GMP). Each of these different types of activities involves product-specific requirements that life sciences organizations must implement. This is based on the type of products they make as well as the country where their products are sold. When life sciences organizations use computerized systems to perform certain GxP activities, they must ensure that the computerized GxP system is developed, validated, and operated appropriately for the intended use of the system.

For a comprehensive approach to using the AWS Cloud for GxP systems, see the Considerations for Using AWS Products in GxP Systems whitepaper.

Use AWS Audit Manager to support your GxP audit preparation

You can use the GxP 21 CFR Part 11 framework in AWS Audit Manager to prepare for audits. It contains 13 automated controls and 14 manual controls. The controls in this framework aren't intended to verify whether your systems are compliant with GxP regulations. Moreover, they can't guarantee that you will pass a GxP assessment. AWS Audit Manager doesn't automatically check procedural controls that require manual evidence collection.

You can find the GxP 21 CFR Part 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.