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Industries that are developing or manufacturing drugs and medical devices are using AWS to build and run computer 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. AWS gives you access to a variety of services that are in use around the world by regulated industries and their partners, and AWS has a whitepaper, developed with contributions from international compliance consulting firm Lachman Consultants, on building validated systems in the cloud.

You can use AWS for GxP or other regulated systems by creating applications, such as:

  • Near real-time alerting
  • Continuous compliance checker

Examples of architecture patterns are shown below. It is recommended that you do your due dilligence, and consult AWS or your internal compliance department before implementing.

 

Example 1: Create near real-time alerting 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 potentally require a change control.

Near Real-time Alerting

Example 2: Create a continuous compliance checker. This can run daily to ensure that each account matches your standard configuration.

Continuous Compliance Checker

We can help you get started with a consultation from our sales and architecture organization, or you can begin your own pilot today.

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