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Rule: AWS Config should be enabled

This rule ensures that AWS Config is enabled as per compliance standards.

RuleAWS Config should be enabled
FrameworkGxP EU Annex 11
Severity
High

Rule/Policy: Enable AWS Config for GxP EU Annex 11 Compliance

Description:

AWS Config is an AWS service that helps you assess, audit, and evaluate the configurations of your AWS resources. Enabling AWS Config for GxP (Good Clinical Practice) EU Annex 11 compliance helps ensure that your AWS resources are configured in accordance with the requirements specified in EU Annex 11 for organizations in the life sciences industry.

By enabling AWS Config, you can continuously monitor and track changes to your AWS resources, identify any non-compliant configurations, and take necessary actions to remediate them. This rule ensures that your AWS environment maintains compliance with GxP EU Annex 11 regulations.

Troubleshooting Steps:

If you encounter any issues while enabling AWS Config for GxP EU Annex 11 compliance, follow these troubleshooting steps:

  1. 1.
    Verify IAM Permissions: Ensure that the IAM user or role attempting to enable AWS Config has the necessary permissions.
  2. 2.
    Check Service Region: Verify that you are enabling AWS Config in the correct region where your AWS resources are located.
  3. 3.
    Review AWS Config Limitations: Check if you have reached any limitations in your AWS account, such as the maximum number of AWS Config rules or insufficient AWS Config service quota. Adjust the configuration or request a quota increase if needed.
  4. 4.
    Review AWS Config Rule Evaluation: Make sure the AWS Config rule, associated with GxP EU Annex 11 compliance, is properly configured and evaluated against your resources.

Necessary Codes/Configurations:

  1. 1.
    IAM Role for AWS Config:
    • Create an IAM role that grants permissions for AWS Config to access and monitor your AWS resources. Include the necessary policies for GxP EU Annex 11 compliance.
    • Assign this IAM role to the AWS Config service.

Step-by-Step Guide for Remediation:

  1. 1.
    Sign in to the AWS Management Console using appropriate credentials.
  2. 2.
    Open the AWS Config console.
  3. 3.
    Select the appropriate region where your AWS resources reside.
  4. 4.
    Click on "Get Started" if it's your first time, or "Settings" if you have already enabled AWS Config.
  5. 5.
    Under "Resource types to record," ensure that all necessary AWS resource types for GxP EU Annex 11 compliance are included.
  6. 6.
    Click on "Continue."
  7. 7.
    For "Amazon SNS topic," select an SNS topic that will receive AWS Config notifications for compliance changes.
  8. 8.
    Click on "Save."
  9. 9.
    On the AWS Config console, navigate to "Rules."
  10. 10.
    Search for or select the AWS Config rule associated with GxP EU Annex 11 compliance.
  11. 11.
    Enable the rule if it's not already enabled.
  12. 12.
    Review the rule configuration and customize it according to your specific requirements.
  13. 13.
    Click on "Save."
  14. 14.
    AWS Config is now enabled for GxP EU Annex 11 compliance in your AWS environment.

Note: Ensure that you periodically review the AWS Config dashboard to identify any non-compliant resources and take remediation actions as needed.

Conclusion:

Enabling AWS Config for GxP EU Annex 11 compliance ensures continuous monitoring and auditing of your AWS resources to meet the regulatory requirements of the life sciences industry. By following the step-by-step guide, you can enable AWS Config and configure the necessary rules to maintain compliance. Regularly review the AWS Config dashboard to identify and rectify any non-compliant resources, thus maintaining a secure and compliant environment.

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