Services / Validation
IQ/OQ/PQ Equipment Validation Services
IQ/OQ/PQ documentation and execution support based on the agreed customer scope, equipment requirements, and approved protocols.
Regulatory & Quality Support
Why Equipment Validation Is Required
Qualification activities are often part of customer quality requirements for equipment used in pharmaceutical manufacturing and quality control. Appropriate IQ/OQ/PQ documentation can support customer review and inspection readiness.
ITS Lab Services provides IQ/OQ/PQ documentation and execution support based on the agreed customer scope, equipment requirements, and approved protocols. Our team has experience supporting 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 team is ready to support your IQ/OQ/PQ documentation and execution needs based on the agreed customer scope and approved protocols.