Supervisory Control and Data Acquisition (SCADA) systems play a crucial role in industrial automation by monitoring, controlling, and managing critical processes. SCADA Validation ensures that these systems function reliably, securely, and in compliance with industry standards.
At Prism Calibration, we offer comprehensive SCADA Validation services, ensuring that industrial automation systems meet regulatory, quality, and cybersecurity standards. Our validation process guarantees accurate data acquisition, seamless system operation, and compliance with FDA, GAMP, and 21 CFR Part 11 regulations.
– Real-Time Process Control: SCADA systems provide continuous monitoring and control of industrial operations.
– Regulatory Compliance: Essential for pharmaceuticals, manufacturing, energy, and utilities to comply with FDA, GAMP, and ISO standards.
– Data Integrity & Security: Ensures accurate data logging, traceability, and cybersecurity protection against threats.
– Operational Efficiency: Automates industrial processes, reducing human errors and improving productivity.
– Preventive Maintenance: Detects faults and anomalies in real-time, preventing downtime and system failures.
– Remote Monitoring & Control: Allows centralized control of multiple facilities from a single location.
– Manufacturing & Production: Automated assembly lines, robotic systems, and industrial machinery.
– Pharmaceutical & Biotechnology: Ensures compliance with FDA 21 CFR Part 11 for data integrity and electronic records.
– Energy & Power Plants: Monitors grid operations, substations, and renewable energy systems for efficiency.
– Water & Wastewater Treatment: Controls pumps, reservoirs, and treatment processes for regulatory compliance.
– Oil & Gas Industry: Supervises pipeline operations, refinery processes, and drilling sites.
– Food & Beverage Processing: Ensures precise temperature, humidity, and production control for quality assurance.
– System Requirement Specification (SRS) Review: Ensures SCADA software and hardware meet operational needs.
– Installation Qualification (IQ): Verifies that SCADA hardware and software are installed correctly and configured per design.
– Operational Qualification (OQ): Tests SCADA system functions, alarms, security features, and data integrity.
– Performance Qualification (PQ): Ensures SCADA system performance under real-world operational conditions.
– Data Integrity Validation: Confirms electronic records, audit trails, and security features meet regulatory requirements.
– Cybersecurity Assessment: Identifies vulnerabilities and ensures compliance with cybersecurity best practices.
– FDA 21 CFR Part 11: Ensures electronic records and signatures are secure, reliable, and compliant with regulatory standards.
– GAMP 5 (Good Automated Manufacturing Practice): Establishes validation best practices for SCADA in pharmaceutical and biotech industries.
– ISA 95 & IEC 62443: Defines standards for SCADA system security and industrial automation architecture.
– ISO 9001 & ISO 27001: Ensures SCADA system quality management and cybersecurity compliance.
– NIST Cybersecurity Framework: Provides guidelines for securing SCADA systems against cyber threats.
– SCADA System Audits: Identifies compliance gaps and risks in existing SCADA infrastructure.
– Software & Firmware Verification: Ensures SCADA applications function as per design specifications.
– Alarm & Event Testing: Validates system alarms, notifications, and data logging accuracy.
– User Access Control Testing: Ensures role-based access to prevent unauthorized system modifications.
– Network & Communication Testing: Verifies real-time data transmission and system connectivity.
– Disaster Recovery & Backup Testing: Assesses system resilience and data recovery in case of failure.
– Validation Master Plan (VMP): Outlines SCADA validation strategies, methodologies, and compliance objectives.
– IQ/OQ/PQ Reports: Detailed documentation of installation, operational, and performance qualifications.
– Audit-Ready Documentation: Ensures compliance with GAMP, FDA, and ISO regulations.
– Cybersecurity & Data Integrity Reports: Identifies system security risks and mitigation strategies.
– Certificate of Compliance: Official validation certification ensuring regulatory adherence.
– Established Expertise – Over 20 years of experience in validation services.
– Comprehensive Solutions – SCADA validation, laboratory instrument validation, HEPA filter validation, software validation, and more.
– ISO/IEC 17025-Accredited Lab – Ensuring globally recognized quality and compliance.
-Regulatory Compliance – Meeting FDA, WHO, GMP, and NABL standards.
– Cutting-Edge Technology – Advanced instruments and latest validation techniques.
– Industry-Specific Validation – Tailored services for pharmaceuticals, healthcare, food, and manufacturing.
– Certified Professionals – Skilled engineers ensuring precision and reliability.
– Fast & Cost-Effective Services – Quick turnaround with detailed, audit-ready reports.
Choose Prism Calibration for reliable and compliant validation services backed by expertise and innovation.
IQ, OQ, PQ testing, cybersecurity assessments, alarm verification, and network security testing are essential validation steps.
It ensures compliance with FDA 21 CFR Part 11, GAMP 5, ISO 9001, IEC 62443, and cybersecurity regulations.
SCADA systems should be validated during installation, system upgrades, and at regular maintenance intervals.
Yes, we provide a detailed validation report and compliance certification for regulatory approval.
We assess firewall configurations, user access controls, encrypted communication, and threat detection strategies.
