Life Sciences

Architecting for GxP compliance

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Sample architecture patterns for using AWS for GxP regulated systems: Near Real-time Alerting: Create near real-time alert to know when a specific event happened, or tried to happen, in the environment. This alerting system could be used for: root account usage, failed authentication attempts and changes to the environment that potentially require a change control. Industries that are developing or manufacturing drugs and medical devices are using AWS to build and run IT systems supporting their Good Laboratory, Clinical, and Manufacturing Practices (GxP). Building GxP systems using AWS allows you to improve the control you have over your IT environment, gives you enhanced testing and traceability, and helps you respond to audits. Learn more in the AWS whitepaper, developed with contributions from international compliance consulting firm Lachman Consultants, on building validated systems in the cloud. Architecting for GxP in the cloud It is recommended that you do your due diligence, and consult AWS or your internal compliance department before implementing. Learn more at https://aws.amazon.com/health/life-sciences-compliance/ Continuous Compliance: Create a continuous compliance checker, which can run daily to ensure that each account matches your standard configuration.

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