Standard Operating Procedure for Data Backup and Restoration

Purpose

The purpose of this SOP is to establish procedures for the routine backup of electronic data and the systematic restoration of data in the event of data loss or system failure. This ensures data integrity, continuity, and compliance with regulatory requirements.

Scope

This SOP applies to all personnel involved in the generation, processing, and storage of electronic data within the pharmaceutical manufacturing facility, including operators, technicians, and IT personnel.

Responsibilities

• Data Owners: Responsible for identifying critical data for backup and ensuring its routine backup in compliance with this SOP.
• IT Personnel: Responsible for implementing and maintaining the data backup system, conducting regular backups, and ensuring the secure restoration of data when needed.
• Quality Assurance Personnel: Responsible for periodically reviewing and verifying the effectiveness of data backup and restoration procedures.

Procedure

1. Identification of Critical Data: Work with data owners to identify and categorize critical electronic data that requires routine backup. This may include raw data, processed data, configuration files, and documentation.
2. Frequency of Backups: Define the frequency of routine backups based on the criticality of the data. Ensure that backup schedules align with regulatory requirements and organizational needs.
3. Backup Methodology: Implement a secure and reliable backup methodology, considering factors such as data volume, storage capacity, and the time required for restoration. Utilize both onsite and offsite backup solutions for redundancy.
4. Backup Validation: Regularly validate the integrity and completeness of backup data through test restorations. Document the validation process and results.
5. Data Restoration Request: Establish procedures for submitting data restoration requests. Clearly define the information required in a restoration request, including the type and date of data needed.
6. Verification of Restoration Requests: Verify the authenticity and authorization of data restoration requests before initiating the restoration process. Maintain logs of restoration requests and approvals.
7. Restoration Process: Clearly document and follow a step-by-step process for data restoration, ensuring that the restored data is accurate, complete, and validated for integrity.
8. Communication: Notify relevant personnel upon the successful restoration of data. Provide information on the availability and location of the restored data.
9. Documentation of Backup and Restoration Activities: Maintain detailed records of all backup and restoration activities, including schedules, validation results, restoration logs, and communication logs.
10. Periodic Review: Conduct periodic reviews of backup and restoration logs to assess the effectiveness of the procedures. Address any identified issues and update the procedures accordingly.
11. Training: Provide training to personnel involved in data backup and restoration activities to ensure a thorough understanding of the procedures and the importance of data integrity.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Data Backup Schedule
• Data Restoration Request Form
• Backup and Restoration Log
• Validation Test Records

Reference

21 CFR Part 11 – Electronic Records; Electronic Signatures

SOP Version

Version 1.0