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GxP Systems on AWS

With limited technical guidance from regulatory and industry bodies, this section aims to describe some of the best practices we’ve seen customers adopting when using cloud services to meet their regulatory compliance needs.

The Final FDA Guidance Document, “Data Integrity and Compliance With Drug CGMP” explicitly brings cloud infrastructure into scope through the revised definition of “computer or related systems”:

“The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific functions. Computer or related systems can refer to computer hardware, software, peripheral devices, networks, cloud infrastructure, personnel and associated documents (e.g., user manuals and standard operating procedures).“

https://docs.aws.amazon.com/whitepapers/latest/gxp-systems-on-aws/aws-products-in-gxp-systems.html