Standard Operating Procedure for Maintenance of IT Infrastructure

1) Purpose

The purpose of this SOP is to establish guidelines for the maintenance of IT infrastructure to ensure availability, security, and reliability of information technology systems in pharmaceutical manufacturing facilities.

2) Scope

This SOP applies to all IT infrastructure components within pharmaceutical manufacturing facilities, including servers, networks, databases, and communication systems.

3) Responsibilities

The IT Department is responsible for implementing and adhering to this SOP. The IT Manager oversees the maintenance of IT infrastructure.

4) Procedure

1. Regular Monitoring
   1. Monitor IT infrastructure performance and availability using monitoring tools and software.
   2. Identify potential issues or abnormalities that may affect system operation.
2. Backup and Recovery
   1. Establish and maintain regular backup schedules for critical data and systems.
   2. Test backup integrity and verify the ability to restore data in case of data loss or system failure.
3. Software Updates and Patches
   1. Implement a schedule for installing software updates, patches, and security fixes.
   2. Ensure updates are applied promptly to mitigate vulnerabilities and enhance system security.
4. Incident Response
   1. Develop and maintain incident response procedures for handling IT security breaches, system failures, or disruptions.
   2. Ensure staff are trained and prepared to respond to IT incidents effectively.
5. Documentation and Reporting
   1. Maintain documentation of IT infrastructure configurations, maintenance activities, and incident reports.
   2. Generate regular reports on IT system health,