Facility Qualification (DQ/IQ/OQ/PQ)
Comprehensive validation cycles confirming that design, installation, operation, and performance limits meet GMP compliance guidelines.
Four Stages of Quality
Our Qualification Framework
DQ
Design Qualification
Verifies that the proposed design of the HVAC system, wall partitions, and airflow patterns matches the target user specifications.
IQ
Installation Qualification
Documents that the dynamic units, sensor controllers, filters, and materials are installed according to layout diagrams.
OQ
Operational Qualification
Verifies that the systems operate as intended throughout all specified operating ranges, testing safety interlocks and alerts.
PQ
Performance Qualification
Demonstrates that the room consistently performs within specifications under full production loads over a specified period.
Visual Workflow
Validation Lifecycle Loop
COMPLIANT
Validation Status Report
HEPA Leak Leak Check (PAO)
Passed (0.003%)
Particle Counts (ISO 7 Limits)
Compliant
Differential Pressure Gradient
Passed (+12 Pa)
Temperature & Humidity Maps
Stable (21.5°C)
Certificate Authority Ref: AZ-QA-2026-NVR
Qualification Compliance Benefits
- Audit Readiness: Clears compliance checks for WHO GMP, EU GMP, ISO 14644, and US FDA regulators.
- Risk Mitigation: Identifies structural airlock leaks or ventilation temperature issues early.
- Product Quality: Ensures consistent environment specifications for sterile products.
- Complete Data: Provides validation files containing calibration certifications and raw log data.
Request Facility Qualification
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