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