Ensure EFS File Systems are Included in Backup Plans
This rule ensures that EFS file systems are part of the backup strategy to prevent data loss.
| Rule | EFS file systems should be in a backup plan |
| Framework | GxP 21 CFR Part 11 |
| Severity | ✔ High |
Rule Description:
EFS (Elastic File System) file systems should be included in the backup plan for GxP (Good Practice) processes that comply with 21 CFR Part 11 regulations. This ensures data integrity, availability, and recoverability in case of any unforeseen events or system failures.
Troubleshooting Steps:
If there are any issues with the backup plan for EFS file systems in relation to GxP 21 CFR Part 11 compliance, follow these troubleshooting steps:
- 1.
Verify Backup Configuration: Ensure that the EFS file system is properly configured for backup and that the necessary backup tools or services are correctly implemented.
- 2.
Check Backup Schedule: Confirm that backups are scheduled at regular intervals to ensure the availability of up-to-date data copies. Check if the backup schedule aligns with the required frequency prescribed by GxP 21 CFR Part 11.
- 3.
Validate Backup Data: Perform periodic checks to verify the backup data integrity and consistency. Ensure that the backup files are accessible and can be restored when required.
- 4.
Review Backup Logs: Analyze the backup logs to identify any errors or warnings related to EFS file system backups. Address any issues promptly to avoid data loss or non-compliance with GxP 21 CFR Part 11.
- 5.
Test Backup Restoration: Regularly perform test restores from the backups to ensure the restoration process works as expected. Validate that the restored data is accurate and complete.
- 6.
Update Backup Procedures: If any issues are identified during the troubleshooting process, update the backup procedures accordingly. Revise and document the steps required to rectify the issues and maintain compliance with GxP 21 CFR Part 11.
Necessary Codes:
No specific codes are mentioned for this rule. However, the following code snippets can be used to interact with EFS file systems using AWS CLI (Command Line Interface):
- 1.Create EFS backup (bash):
aws efs create-backup --file-system-id <filesystem-id>
- 1.Restore EFS backup (bash):
aws efs restore-backup --backup-id <backup-id> --file-system-id <filesystem-id>
Step-by-Step Guide for Remediation:
- 1.
Review Backup Plan: Evaluate the existing backup plan to ensure it includes EFS file systems. Determine if it complies with the requirements of GxP 21 CFR Part 11.
- 2.
Configure Backup Tools: Set up and configure the necessary backup tools or services capable of handling EFS file system backups. Ensure they are compatible with the AWS EFS service.
- 3.
Schedule Backups: Establish a backup schedule that aligns with the required frequency outlined in GxP 21 CFR Part 11. Set up automated backups to ensure consistent and timely data protection.
- 4.
Monitor Backup Process: Regularly monitor the backup process to ensure it runs smoothly without any errors or interruptions. Keep track of backup logs for future reference.
- 5.
Validate Backups: Periodically validate the integrity and consistency of the backup data. Verify that the backup files can be accessed and restored without any issues.
- 6.
Perform Test Restores: Conduct test restores from the backups to validate the restoration process. Ensure the restored data is accurate and complete.
- 7.
Update Backup Procedures: Document any changes or updates made to the backup procedures. Include troubleshooting steps, if any, to address potential issues related to EFS file system backups.
- 8.
Maintain Compliance: Continuously review and refine the backup plan to ensure ongoing compliance with GxP 21 CFR Part 11. Stay up-to-date with any changes in the regulations and adjust the backup strategy accordingly.
Note: The above steps assume the use of AWS EFS for managing the file systems. If using a different service or platform, adjust the steps accordingly while adhering to the GxP 21 CFR Part 11 requirements.