Validation of a SCADA System Within CSV

Steps in SCADA (Supervisory Control and Data Acquisition) System Validation:

  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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.
  1. 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

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