OQ (Operational Qualification) is a key phase in Computerized System Validation (CSV). It involves verifying that a system or piece of equipment performs its intended functions under specified operating conditions. In the context of CSV, OQ ensures that the computerized system operates according to its design specifications and performs as expected within defined ranges.
Key aspects of OQ in CSV include:
1. Test Scripts: During OQ, pre-approved test scripts are executed to verify the system's functionality. These scripts simulate actual use cases and operational scenarios.
2. System Configuration: The system's configuration settings are tested to ensure they meet user and operational requirements.
3. Security and Access Controls: OQ ensures that user access levels, passwords, and security features function correctly according to the validation plan.
4. Alarms and Notifications: Alarm functions and notifications are tested to confirm that they trigger as expected when thresholds are exceeded.
5. Documentation: All results of the OQ testing must be documented, including any deviations and corrective actions.
Operational Qualification typically follows the Installation Qualification (IQ) phase and is followed by the Performance Qualification (PQ) in CSV.
Read also:
- Computerized System Validation (CSV) Audits
- GAMP V-Model to SCRUM | CSV Refresh
- Difference Between CSV and CSA
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