Operational Qualification should cover the following but is not limited to:
- Input/output testing
- Alarm and message handling
- Reporting
- Security
- Audit Trail for Electronic Records
- Fail Safe Modes
- Power Failure Recovery
- Demonstration of standard functionality of commercial off the shelf (COTS) applications/packages
- Electronic Record and Signature Functions
- Application Software, sequential operation
- Critical Algorithm Testing
- Interface Communications to related systems
- Confirmation of system backup / restore and archiving / retrieval functions