Services / Validation
IQ/OQ/PQ Equipment Validation Services
Comprehensive installation, operational, and performance qualification services meeting FDA 21 CFR, USP, and cGMP requirements. Audit-ready documentation packages delivered by certified validation engineers.
Regulatory Compliance
Why Equipment Validation Is Required
FDA regulations require that equipment used in pharmaceutical manufacturing and quality control be qualified and validated. Without proper IQ/OQ/PQ documentation, your facility faces significant regulatory risk during inspections and audits.
ITS Lab Services provides complete validation packages that satisfy FDA 21 CFR Part 211, USP general chapters, and ICH Q7 requirements. Our validation engineers have extensive experience with pharmaceutical and biotech regulatory environments.
The Three Phases
IQ / OQ / PQ — What Each Phase Covers
Installation Qualification
Verify the equipment is installed correctly
IQ documents that the equipment has been delivered and installed according to manufacturer specifications and your facility requirements. It establishes the baseline for all subsequent qualification activities.
Key Deliverables
- Equipment identification and serial number documentation
- Utility and environmental requirements verification
- Installation checklist completion
- Component and accessory inventory
- Software version documentation
- Vendor documentation review
Operational Qualification
Confirm the equipment operates per specifications
OQ demonstrates that the equipment operates correctly throughout its intended operating range. All functions, alarms, and safety features are tested and documented to confirm they perform as designed.
Key Deliverables
- Functional testing of all operating modes
- Alarm and safety system verification
- Operating parameter range testing
- Software functionality testing
- Calibration verification
- Operator training documentation
Performance Qualification
Demonstrate consistent performance in actual use
PQ provides documented evidence that the equipment consistently performs within predetermined specifications under actual use conditions. This is the final step before the equipment is released for routine use.
Key Deliverables
- Performance testing with actual process materials
- Reproducibility and repeatability studies
- Accuracy and precision verification
- Worst-case scenario testing
- Acceptance criteria evaluation
- Final qualification report and approval
Scope
Equipment We Validate
Ready to Validate Your Equipment?
Our validation engineers are ready to help. We deliver audit-ready IQ/OQ/PQ packages that satisfy FDA inspectors and internal quality audits.