Rule: EFS File Systems Should Be Protected by Backup Plan

Rule Description:

Troubleshooting Steps:

2. 1.

   Verify Backup Plan Status: Check if there is an existing backup plan in place for the EFS file system. Ensure that the plan is up to date and adheres to the requirements defined in GxP EU Annex 11.

4. 2.

   Data Loss Identification: Identify the extent of data loss or system failure that has occurred. Determine if it is a complete loss or partial loss of data.

6. 3.

   Identify Failure Causes: Investigate the cause behind the data loss or system failure. This may include factors such as hardware failure, human error, or software glitches.

8. 4.

   Restore from Backup: If a backup plan is available, initiate the process of restoring data from the latest backup. Ensure that the restoration process is in compliance with GxP EU Annex 11 requirements.

10. 5.

    Data Integrity Verification: Once the data is restored, perform integrity checks to ensure that the restored data matches the original data present before the data loss or system failure.

12. 6.

    Address Underlying Issues: Identify and address any underlying issues that led to the data loss or system failure. This may involve fixing hardware or software problems, improving backup processes, or providing adequate training to personnel responsible for managing the EFS file system.

Necessary Codes (if applicable):

import boto3

efs_file_system_id = 'fs-12345678'  # Replace with your EFS file system ID
backup_bucket_name = 'your-backup-bucket'  # Replace with your backup bucket name

def create_backup():
    client = boto3.client('efs')
    
    response = client.create_backup(
        FileSystemId=efs_file_system_id,
        BackupType='USER_INITIATED'
    )
    
    backup_id = response['Backup']['BackupId']
    
    s3_client = boto3.client('s3')
    
    s3_client.upload_file(backup_id, backup_bucket_name)
    
    print(f"Backup {backup_id} created and uploaded to S3 bucket {backup_bucket_name}.")

create_backup()

Remediation Steps:

2. 1.

   Review GxP EU Annex 11 Requirements: Understand the specific backup requirements mentioned in GxP EU Annex 11. Familiarize yourself with the data integrity and availability standards that need to be met.

4. 2.

   Create Backup Plan: Develop a comprehensive backup plan that includes regular, automated backups of the EFS file systems. Consider factors like backup frequency, retention periods, and data restoration procedures.

6. 3.

   Implement Backup Automation (Optional): If possible, automate the backup process using tools or scripts. This reduces the chances of human error and ensures consistent backup schedules.

8. 4.

   Verify Backup Plan Configuration: Validate that the backup plan meets the requirements set forth in GxP EU Annex 11. Ensure that the plan addresses data integrity, availability, retention, and restoration procedures.

10. 5.

    Test Backup and Restore Procedures: Simulate data loss or system failure scenarios to test the effectiveness of the backup plan. Verify that backups can be restored successfully and that data integrity is maintained throughout the process.

12. 6.

    Document Backup Plan: Document the backup plan, including all relevant details such as backup frequency, retention periods, responsible personnel, and restoration procedures. Make this documentation easily accessible to authorized personnel.

14. 7.

    Train Personnel: Educate staff members who are responsible for managing the EFS file systems about the backup plan and its importance. Train them on backup and restore procedures to ensure smooth execution when required.