Learnaboutgmp Community

List of OQ requirements

Guys,

I am currently developing an OQ for my company, have I forgotton any major

items that I should include.

• Personnel performing the activities
• Testing of the software and hardware configuration parameters
• The use of any data migration tools. The data migration process should be verified and the verification performed before final loading for release
• Verification of applicable functions
• Verification of the executed technologies installation qualification
• Audit trails
• Electronic signatures
• Alarms, alarm action, events, interlocks, and safety circuit testing
• Confirmation of data acquisition
• Algorithm, data handling, and report generation
• Timers (if applicable)
• Power failure and recovery
• Disaster recovery
• Proper communication between the computer system and its peripherals
• Restart and recovery functions and procedures
• Integration with other computer systems

any feedback would be appreciated.

Regards

Peter