Rule: Secrets Manager Secrets Rotation Schedule

Rule Description:

Rule Details:

2. 1.

   Secrets Rotation Schedule: The specific secrets rotation schedule for GxP 21 CFR Part 11 compliance must be established and adhered to. This schedule should specify how often the secrets need to be rotated, considering the level of risk associated with the secret and the compliance requirements of the organization.

4. 2.

   Secrets Management Policy: A policy document should be created that outlines the process for managing secrets rotation. This policy should include responsibilities, procedures, and guidelines for carrying out secrets rotation, ensuring compliance with GxP 21 CFR Part 11 regulations.

6. 3.

   Identification of Secrets: Identify the specific secrets that fall under GxP 21 CFR Part 11 compliance. These may include database credentials, API keys, encryption keys, or any other sensitive information that needs to be managed by Secrets Manager.

8. 4.

   Automated Rotation: Establish automated processes or scripts to facilitate the rotation of the identified secrets within the Secrets Manager. Automation helps ensure consistency and accuracy in the rotation process and reduces the risk of human error.

10. 5.

    Secure Rotation Process: Develop a secure rotation process to prevent unauthorized access to the secrets during rotation. This may include ensuring secrets are encrypted at rest and transit, restricting access to authorized personnel, and implementing strong authentication and authorization mechanisms.

12. 6.

    Logging and Auditing: Implement logging and auditing mechanisms to track secrets rotation activities. This allows for the monitoring of compliance with the rotation schedule and ensures that any unauthorized access attempts or irregularities can be identified and addressed promptly.

Troubleshooting Steps:

2. 1.

   Check Secrets Manager Configuration: Ensure that Secrets Manager is properly configured and integrated with the relevant systems and services. Verify that the rotation schedule is accurately set and aligned with GxP 21 CFR Part 11 compliance requirements.

4. 2.

   Review Automation Scripts/Processes: Examine the automation scripts or processes responsible for the secrets rotation. Check for any errors, misconfigurations, or issues that could be impacting the rotation process.

6. 3.

   Verify Access Permissions: Validate that the users or roles responsible for secrets rotation have the necessary permissions and access rights to initiate the rotation process. Ensure proper authentication and authorization mechanisms are in place.

8. 4.

   Review Logs and Audit Trails: Analyze the logs and audit trails of Secrets Manager to identify any errors, warnings, or irregularities that may indicate issues during the rotation process. Investigate and address any identified issues accordingly.

10. 5.

    Engage IT Support or Security Teams: If the troubleshooting steps above do not resolve the issue, involve IT support or security teams to provide further assistance in diagnosing and resolving any technical problems with the secrets rotation process.

Necessary Codes:

import boto3

def rotate_secret(secret_id):
    client = boto3.client('secretsmanager')
    response = client.rotate_secret(SecretId=secret_id)

    # Optional: Check response and handle any errors or warnings appropriately

    return response

# Example Usage:
response = rotate_secret('my-secret-id')
print(response)

Step-by-Step Guide for Remediation:

2. 1.

   Step 1: Define Secrets Rotation Schedule: Determine the appropriate rotation schedule based on the compliance requirements and the sensitivity of the secrets managed by Secrets Manager.

4. 2.

   Step 2: Identify Secrets: Identify the secrets that need to be rotated according to GxP 21 CFR Part 11 compliance. This may include database credentials, API keys, or any other sensitive information.

6. 3.

   Step 3: Develop Secrets Rotation Policy: Create a policy document that outlines the procedures, responsibilities, and guidelines for rotating the identified secrets. Ensure that the policy aligns with the compliance requirements of GxP 21 CFR Part 11.

8. 4.

   Step 4: Automate Secrets Rotation: Develop or modify existing automation scripts or processes to enable automated secrets rotation using the Secrets Manager SDK or AWS CLI. Incorporate the necessary checks and validations to ensure a secure and error-free rotation process.

10. 5.

    Step 5: Test Secrets Rotation: Conduct thorough testing of the automated secrets rotation process to verify its effectiveness and reliability. Validate that secrets are successfully rotated and operational systems are not impacted.

12. 6.

    Step 6: Implement Logging and Auditing: Enable comprehensive logging and auditing mechanisms to track secrets rotation activities. Monitor the rotation process regularly to ensure compliance with the scheduled rotation intervals and identify any irregularities.

14. 7.

    Step 7: Update Documentation: Maintain up-to-date documentation that includes the secrets rotation schedule, policies, procedures, and any other relevant information. This documentation should be easily accessible to authorized personnel involved in managing secrets rotation.