Rule: EC2 instances should have a backup plan
This rule emphasizes the importance of protecting EC2 instances with a backup plan.
| Rule | EC2 instances should be protected by backup plan |
| Framework | GxP EU Annex 11 |
| Severity | ✔ Medium |
EC2 Instances Backup Plan for GxP EU Annex 11 Compliance
Complying with EU Annex 11’s Good Automated Manufacturing Practice (GAMP) requires that electronic records and critical systems, such as EC2 instances in AWS, are adequately backed up to safeguard data integrity and availability. Here is a detailed guide on how to enforce an EC2 backup plan that aligns with GxP EU Annex 11 requirements.
Rule Description
This rule states that all EC2 instances, particularly those used in regulated environments subject to GxP guidelines, must be backed up according to a predefined schedule. Backup policies should ensure that:
- Data critical to the manufacturing process is not lost.
- Backups are secured and encrypted.
- Backup and restore procedures are tested regularly.
- A documented backup plan is in place.
Troubleshooting Steps
If an EC2 instance is not being backed up according to the GxP EU Annex 11 guidelines, follow these troubleshooting steps:
- 1.
Verify Backup Configuration:
- Check if the Amazon Data Lifecycle Manager is set up correctly.
- Ensure the backup policy includes all critical EC2 instances.
- 2.
Validate Encryption and Security:
- Confirm that backups are encrypted using keys managed by AWS KMS.
- Review IAM roles and permissions to ensure proper access control.
- 3.
Check Backup Frequency and Retention:
- Ensure that the backup frequency aligns with the GxP requirements.
- Make sure the retention period for backups is sufficiently long to comply with regulatory standards.
- 4.
Confirm Restore Capability:
- Periodically perform restore tests to validate the integrity of the backup data.
Required AWS CLI Commands
To manage backups for EC2 instances via the AWS CLI, you can use the following commands:
To create a snapshot of an EC2 instance:
aws ec2 create-snapshot --volume-id <volume-id> --description "Backup for GxP compliance"To automate snapshots creation with a schedule using Amazon Data Lifecycle Manager:
aws dlm create-lifecycle-policy --execution-role-arn <role-arn> --description "GxP Backup Policy" --state ENABLED --policy-details file://policy.jsonCreate a
file that defines your backup policy details including the schedule, target tags, and retention rules.policy.jsonTo verify the policy:
aws dlm get-lifecycle-policies --policy-ids <policy-id>To recover an instance from a snapshot:
aws ec2 create-image --instance-id <instance-id> --name "Instance Recovery Image"
Step by Step Guide for Remediation
- 1.
Identify EC2 Instances:
- Tag all EC2 instances that fall under GxP compliance.
- 2.
Configure AWS Backup:
- Use AWS Backup service to create a centralized backup plan.
- Specify the backup frequency and retention rules.
- 3.
Implement Encryption:
- Utilize AWS Key Management Service (KMS) to encrypt snapshots.
- Apply appropriate IAM policies to restrict backup access.
- 4.
Test Restore Procedures:
- Schedule regular drills to ensure you can successfully restore data from backups.
- 5.
Document the Backup Plan:
- Create comprehensive documentation for your backup and restore procedures.
- Include this in your GxP compliance records.
- 6.
Monitor & Review:
- Continually monitor your backup processes and modify if necessary.
- Conduct regular reviews to ensure ongoing compliance and adjust the plan as required.
These details provide a clear and precise outline of how to ensure your EC2 instances remain compliant with the GxP EU Annex 11 requirements, avoiding common pitfalls, and maintaining both data integrity and regulatory compliance. Please replace placeholders like
<volume-id><role-arn>