Steps in SCADA (Supervisory Control and Data Acquisition) System Validation:
- System Requirements Specification (SRS):
- This is where you define the intended use of the SCADA system, along with functional and operational requirements.
- The document should include control, monitoring, and reporting functionalities, including interfaces with other systems such as PLCs, MES, and databases.
- Risk Assessment:
- Perform a risk analysis to identify critical elements of the SCADA system that might affect product quality or data integrity.
- Based on the assessment, establish the level of validation activities required.
- Design Qualification (DQ):
- Evaluate and document that the SCADA system design meets the predefined requirements.
- Ensure that security measures, data handling, and system architecture are aligned with regulatory standards.
- Installation Qualification (IQ):
- Verify that the SCADA system is properly installed according to the manufacturer’s recommendations and design specifications.
- Document hardware configurations, software installation, network setup, and interface connections.
- Operational Qualification (OQ):
- Test the functionality of the SCADA system under normal operating conditions to ensure that it performs as expected.
- Key elements tested include alarms, data acquisition, monitoring systems, control systems, and communication with external devices or databases.
- Performance Qualification (PQ):
- Validate that the SCADA system operates effectively in the real-world environment under actual production conditions.
- Testing should focus on performance consistency, data integrity, and system reliability over extended periods.
- Security and Data Integrity Testing:
- Ensure that the SCADA system complies with 21 CFR Part 11, which governs electronic records and signatures.
- Test access control, audit trails, and data retention policies to ensure that only authorized users can access the system and that records are accurate and traceable.
- Backup and Recovery Testing:
- Validate that the system has reliable backup mechanisms and that data can be recovered in case of a system failure or power outage.
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Resource Person: Mohamed Mahmoud