Ensuring Precision, Compliance, and System Integrity

In regulated industries like pharmaceuticals, biotechnology, and medical devices, automation plays a critical role in ensuring process efficiency, accuracy, and regulatory compliance. Systems such as Programmable Logic Controllers (PLC), Human-Machine Interfaces (HMI), Industrial PCs (IPC), and Supervisory Control and Data Acquisition (SCADA) are essential for real-time monitoring and control of manufacturing operations. However, without proper validation, these systems can pose risks related to data integrity, security breaches, and regulatory non-compliance.

Validation of PLC, HMI, IPC, and SCADA systems ensures that automated processes adhere to regulatory standards like FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and ISA-95, guaranteeing system reliability, audit readiness, and data security.

Key Phases of PLC/HMI/IPC/SCADA Validation

• System Risk Assessment & Gap Analysis – Identify potential compliance risks in automation processes
• Hardware & Software Qualification (IQ, OQ, PQ) – Verify installation, operational performance, and process stability
• Data Integrity & Security Compliance – Validate audit trails, role-based access, and electronic records
• Functional Testing & Process Simulation – Ensure the system meets defined user requirements
• Change Control & Revalidation – Maintain continuous compliance during system updates

Why Validate PLC/HMI/IPC/SCADA Systems?

Enhances process control, efficiency, and automation reliability

Ensures compliance with regulatory standards and industry best practices

Prevents system failures, data loss, and production downtime

Facilitates seamless audits and regulatory inspections

At SmartSPOC, we provide end-to-end validation services for PLC, HMI, IPC, and SCADA systems, ensuring smooth automation, regulatory adherence, and secure operations in highly regulated environments.

Ensure your automation systems are compliant, secure, and audit-ready.