Building a Strong Foundation for Compliance & Security

A well-qualified IT infrastructure is the backbone of regulatory compliance, ensuring data integrity, system reliability , and operational continuity in regulated industries such as pharmaceuticals, biotechnology, and medical devices. IT Infrastructure Qualification (IT IQ) verifies that servers, networks, databases, and cloud environments are properly installed, configured, and maintained in alignment with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and industry best practices.

Key Phases of IT Infrastructure Qualification

• Assessment & Planning – Define qualification scope and regulatory requirements
• Installation Qualification (IQ) – Verify proper setup of hardware, operating systems, and security controls
• Operational Qualification (OQ) – Ensure system functionality, data security, and performance under normal conditions
• Performance Qualification (PQ) – Validate system stability under real-world operational scenarios
• Ongoing Compliance – Implement change control, periodic requalification, and continuous monitoring

Why IT Infrastructure Qualification Matters?

Prevents compliance risks, security breaches, and system failures

Ensures business continuity and data integrity

Supports audit readiness and regulatory compliance

At SmartSPOC, we help organizations establish a qualified, secure, and compliant IT infrastructure tailored to industry regulations and business needs.

Secure your IT landscape with our expert qualification services.