Rule: EBS Volumes in Backup Plan
This rule ensures EBS volumes are included in a backup plan for data protection.
| Rule | EBS volumes should be in a backup plan |
| Framework | GxP 21 CFR Part 11 |
| Severity | ✔ High |
Rule/Policy: EBS volumes backup for GxP 21 CFR Part 11 Compliance
Description:
In order to comply with GxP (Good Practice for Pharmaceutical and Medical Devices) regulations, specifically 21 CFR Part 11, it is essential to have a backup plan in place for the Amazon Elastic Block Store (EBS) volumes used within your infrastructure. This policy ensures that critical data stored in EBS volumes is protected and can be restored in case of any data loss or system failure.
Troubleshooting Steps:
N/A (No specific troubleshooting steps are mentioned for this policy.)
Necessary Codes:
N/A (No specific codes are mentioned for this policy.)
Remediation Guide:
To comply with the EBS volume backup rule for GxP 21 CFR Part 11, follow these step-by-step instructions:
- 1.Identify the EBS volumes used in your infrastructure that store critical GxP data.
- 2.Determine the backup frequency and retention period required by your organization's GxP compliance policies. This will depend on the level of data criticality and the regulatory requirements specific to your industry.
- 3.Evaluate the available backup options provided by AWS, such as Amazon EBS snapshots, third-party backup solutions, or AWS Backup.
- 4.Select an appropriate backup solution based on your organization's requirements, budget, and technical capabilities.
- 5.Create a backup plan that includes the following components:
- Backup frequency: Determine how often backups should be taken. This can vary from daily to weekly or even more frequently, based on the criticality of the data.
- Retention period: Define how long each backup should be retained. This should align with your organization's data retention policies and any regulatory requirements.
- Backup storage location: Determine where the backups will be stored, such as Amazon S3 or another secure storage option.
- Backup schedule: Create a schedule for when backups should be initiated. It is recommended to schedule backups during off-peak hours to minimize impact on production systems.
- 6.Configure automated backup processes, if available, to ensure consistent and timely backups.
- 7.Perform a trial backup and test the restoration process to validate the backup plan and ensure data integrity.
- 8.Document the backup plan, including the backup schedule, retention policy, and restoration procedures, as part of your organization's GxP documentation.
- 9.Regularly review and update the backup plan to accommodate changes in the infrastructure, data volumes, and regulatory requirements.
Following these steps will help ensure that your EBS volumes are included in a backup plan that adheres to GxP 21 CFR Part 11 compliance guidelines.