SAC314: GxP Compliance in the Cloud

GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers and to ensure the integrity of data used to make product-related safety decisions. The term GxP encompasses a broad range of compliance-related activities such as Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and others, each of which has product-specific requirements that life sciences organizations must implement based on the 1) type of products they make and 2) country in which 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 this session, co-presented with Merck, services such as Amazon EC2, Amazon CloudWatch Logs, AWS CloudTrail, AWS CodeCommit, Amazon Simple Storage Service (S3), and AWS CodePipeline will be discussed with an emphasis on implementing GxP-compliant systems in the AWS Cloud.