Standard Operating Procedure for Data Backup and Recovery

Purpose

The purpose of these procedures is to establish a systematic and secure approach to data backup and recovery to prevent data loss, ensure data recoverability, and maintain data integrity within the pharmaceutical manufacturing facility.

Scope

These procedures apply to all electronic systems and data repositories used in pharmaceutical manufacturing, including but not limited to manufacturing equipment, laboratory instruments, and data management systems.

Data Backup Procedures

1. Scheduled Backups: Regularly schedule automated backups of critical electronic systems and data repositories.
2. Backup Frequency: Determine the appropriate frequency of backups based on the criticality of the data, with a minimum of [Specify Frequency].
3. Data Selection: Identify and include all critical data, including raw data, metadata, and system configurations in the backup process.
4. Storage Location: Store backup data in a secure, offsite location to prevent loss in the event of on-site disasters.
5. Encryption: Encrypt backup data to ensure confidentiality and prevent unauthorized access during storage and transmission.
6. Validation: Periodically validate the backup process to ensure the integrity and completeness of the stored data.
7. Documentation: Maintain detailed documentation of the backup procedures, including schedules, data selection criteria, and storage locations.

Data Recovery Procedures

1. Identification of Data Loss: Promptly identify and document instances of data loss or corruption through regular monitoring and system checks.
2. Notification: Notify relevant personnel, including IT support and quality assurance, as soon as data loss or corruption is identified.
3. Isolation: Isolate affected systems or equipment to prevent further data loss or damage.
4. Root Cause Analysis: Conduct a thorough investigation to determine the root cause of data loss or corruption.
5. Recovery Plan: Develop a recovery plan outlining the steps to be taken to restore data and system functionality.
6. Data Restoration: Restore data from the most recent validated backup using secure and validated procedures.
7. Validation: Validate the restored data to ensure its integrity, accuracy, and completeness.
8. Documentation: Document the entire data recovery process, including root cause analysis, actions taken, and validation results.

Responsibilities

All personnel responsible for electronic systems and data repositories are responsible for adhering to these backup and recovery procedures. The IT department is specifically responsible for implementing and overseeing these procedures.

Review and Revision

These Data Backup and Recovery Procedures will be reviewed annually and revised as necessary to ensure their continued effectiveness and relevance.

Approval

These Data Backup and Recovery Procedures have been approved and authorized by [Name], [Title], on [Date].