GxP

Yes. For a comprehensive approach to using the AWS Cloud for GxP systems, see the whitepaper GxP Systems on AWS. This whitepaper was developed based on experience with and feedback from AWS pharmaceutical and medical device customers, as well as software partners, who are currently using AWS services in their validated GxP systems.

AWS also has other security and quality certifications such as ISO 9001, ISO 27001, ISO 27017, and ISO 27018, and is compliant with NIST 800-53 under the FedRAMP compliance program.

Yes, numerous AWS customers have successfully developed, validated, and operated all or part of their GxP system using AWS services. AWS regularly works with GxP customers and their auditors in planning for, developing, validating, operating, and auditing GxP systems that use AWS services as a component. Because of confidentiality agreements, we do not disclose specific company details and use cases of GxP systems in AWS.

In the United States (US), GxP regulations are enforced by the US Food and Drug Administration (FDA) and are contained in Title 21 of the Code of Federal Regulations (21 CFR). Within 21 CFR, Part 11 contains the requirements for computer systems that create, modify, maintain, archive, retrieve, or distribute electronic records and electronic signatures in support of GxP-regulated activities (and in the EU, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines – Annex 11 Computerised Systems). Part 11 was created to permit the adoption of new information technologies by FDA-regulated life sciences organizations, while simultaneously providing a framework to ensure that the electronic GxP data is trustworthy and reliable.

There is no GxP certification for a commercial cloud provider such as AWS. AWS offers commercial off-the-shelf (COTS) IT services according to IT quality and security standards such as ISO 27001, ISO 27017, ISO 27018, ISO 9001, NIST 800-53 and many others. GxP-regulated life sciences organizations are responsible for purchasing and using AWS services to develop and operate their GxP systems, and to verify their own GxP compliance.