Rule: RDS DB Instance Protected by Backup Plan
Ensure RDS DB instance is protected by a backup plan to maintain data integrity and security.
| Rule | RDS DB instance should be protected by backup plan |
| Framework | GxP EU Annex 11 |
| Severity | ✔ High |
Ensuring RDS DB Instance Compliance with GxP EU Annex 11 Backup Requirements
To comply with the Good Automated Manufacturing Practice (GAMP) standards, especially the EU's Annex 11, your Amazon RDS (Relational Database Service) database instances should be configured with a robust backup strategy. This strategy must incorporate automated backups, backup retention, and the ability to recover data in the event of a loss.
Understanding GxP EU Annex 11 Backup Requirements
The EU Annex 11 corresponds to the Computer Systems section of the GMP (Good Manufacturing Practice) guidelines. It emphasizes the integrity and availability of data. For databases, this translates to a stringent backup regimen. Key directives include:
- Data Integrity: Ensuring that data is complete, consistent, and accurate throughout its lifecycle.
- Data Availability: Having data accessible for retrieval whenever needed, which relies on an effective backup plan.
Configuring Automated Backups in RDS for Compliance
Step 1: Enabling Automated Backups
- 1.Sign in to the AWS Management Console.
- 2.Navigate to the RDS dashboard.
- 3.Select the DB instance that you want to configure for GxP compliance.
- 4.Under the
dropdown, selectInstance Actions
.Modify - 5.Scroll to the
section.Backup - 6.For
, enter a suitable value that complies with GxP requirements (typically between 7 to 35 days).Backup Retention Period - 7.Ensure that
is enabled.Automatic Backup - 8.Review any other backup settings according to your organizational policies.
- 9.Click
and thenContinue
to apply the changes.Modify DB Instance
Step 2: Verifying Backup Settings
Use the following AWS CLI command to describe the DB instance and verify its backup settings:
aws rds describe-db-instances --db-instance-identifier your-instance-id
Look for
"BackupRetentionPeriod""PreferredBackupWindow"Implementing a Manual Snapshot Strategy
Step 1: Creating a DB Snapshot
- 1.In the RDS dashboard, select the database instance.
- 2.Choose
, and thenInstance Actions
.Take Snapshot - 3.Enter the name for the snapshot and click
.Take Snapshot
Alternatively, take snapshots via AWS CLI:
aws rds create-db-snapshot --db-instance-identifier your-instance-id --db-snapshot-identifier your-snapshot-id
Step 2: Managing Snapshot Lifecycle
Use AWS Backup or a custom script to manage the lifecycle of snapshots to comply with GxP standards, ensuring that snapshots are retained for the required period and then deleted.
Planning for Disaster Recovery (DR)
For GxP compliance, a DR plan is critical. It should include:
- Multi-AZ Deployments: For high availability and data durability.
- Read Replicas: For data redundancy.
- Cross-Region Backups: Protect against regional disruptions.
Periodic Testing of Backup and Recovery
Regularly test your backup and recovery process to ensure compliance. Create test instances from backups and ensure the recovery meets the RDS Recovery Point Objective (RPO) and Recovery Time Objective (RTO).
Remediation and Troubleshooting Steps
If the backup strategy is not meeting GxP EU Annex 11 requirements:
- 1.Verify that automatic backups are enabled with the correct retention period.
- 2.Check that manual snapshots are taken as per the backup plan.
- 3.Monitor and ensure successful completion of backup jobs.
- 4.Confirm that the DR strategy is robust and aligns with regulatory standards.
Compliance Monitoring
Finally, employ AWS services or third-party solutions to monitor and report on compliance. Services like AWS Config, CloudTrail, and third-party GxP compliance auditing tools can be invaluable.
Ensure you also update and maintain documentation that reflects the backup policies, procedures, and practices as required by GxP EU Annex 11 regulations.
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