Rule: AWS Account Should Be Part of AWS Organizations
This rule highlights the necessity for AWS accounts to be integrated within AWS Organizations for greater control and security.
| Rule | AWS account should be part of AWS Organizations |
| Framework | GxP 21 CFR Part 11 |
| Severity | ✔ High |
Rule Description:
The rule requires that the AWS account should be part of AWS Organizations to ensure compliance with the GxP (Good Clinical Practice) regulations outlined in 21 CFR Part 11. This regulation sets forth the criteria for electronic records and electronic signatures used in FDA-regulated clinical research.
Troubleshooting Steps:
No troubleshooting steps available for this rule.
Necessary Code:
No code required for this rule.
Step-by-Step Guide for Remediation:
- 1.Sign in to the AWS Management Console using the root account credentials.
- 2.Open the AWS Organizations console.
- 3.Click on "Get Started" to create a new organization if you haven't already done so. If you already have an organization, skip to step 7.
- 4.Choose the option to create a new organization and click on "Create Organization."
- 5.Enter an organization name and an optional email address for notifications, then click on "Create Organization."
- 6.Follow the on-screen instructions to complete the setup of your organization. This includes setting a payment method, accepting the AWS Customer Agreement, and configuring enablement of AWS Organizations features.
- 7.Once your organization is set up, select the root account in the AWS Organizations console.
- 8.Under the Account settings tab, click on "Add Account."
- 9.Choose the option to add an existing AWS account and enter the 12-digit account ID of the AWS account you want to add, then click on "Add Account."
- 10.Follow the on-screen instructions to complete the process of adding the AWS account to your organization.
- 11.After the account has been added to the organization, it will be listed under the Accounts section in the AWS Organizations console.
Additional Notes:
By joining an AWS account to an AWS Organization, the account becomes a member account and inherits the policies and settings defined at the organization level. This allows for centralized management and control of multiple AWS accounts, ensuring compliance with GxP 21 CFR Part 11 requirements. Additionally, it provides the ability to set up consolidated billing, streamlining resource allocation and cost management.