Rule: Backup Recovery Points Manual Deletion Disabled

In regulated industries such as pharmaceuticals, the guidelines such as Good Practice (GxP) and regulations like the EU Annex 11 are critical. These require strict adherence to data integrity and security protocols. Disabling manual deletion of backup recovery points is a crucial part of maintaining compliance with these regulations.

The practice of disabling manual deletion for backup recovery points is implemented to ensure that critical data is not lost or corrupted. In the context of GxP and EU Annex 11, modification, deletion, or tampering with the archived data can lead to non-compliance, which is unacceptably risky from both a regulatory and a business continuity perspective.

Ensure that your data backup system allows for policy-based management of backups that can restrict manual deletion.

Set up backup policies that create immutable snapshots which cannot be altered or deleted until the specified retention period lapses.

Modify user permissions to limit functionality such that manual deletion of backups cannot be carried out by end users.

Implement automatic verification of backups to ensure they can be restored. Alerts should notify administrators of any issues.

Continuous monitoring and regular auditing are necessary to ensure compliance is maintained. Any attempt at manual deletion should be logged and alerts should be triggered.

• Ensure policies are properly applied and the Data Backup System service is running.
• Verify user permissions reflect the policy accurately.
• Check system logs for errors relating to backup policies or failed attempts to delete backup recovery points.
• If changes are made, test backup immutability by attempting a controlled and documented deletion operation in a non-production environment.

Should you discover that manual deletion is still possible, you can take the following steps:

Ensure that only authorized personnel have administrative access to backup systems and data repositories.

Strengthen policies to enforce immutability. This often requires administrative privileges and might involve backend configuration.

After making changes, perform tests to validate that manual deletions are not permitted.

Keep detailed records of policy changes and testing procedures to demonstrate compliance efforts.

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