IQ/OQ/PQ Qualification Services for Regulatory Compliance
Compliance isn’t optional—it’s the foundation of reliable, audit-ready science. At Nautilus Precision, our qualification services ensure every instrument is correctly installed, fully operational, and validated to perform under real lab conditions.
From Installation Qualification (IQ) that verifies setup, to Operational Qualification (OQ) that confirms consistent functionality, and Performance Qualification (PQ) that tests real-world reproducibility, we cover every stage with precision. All services are delivered by experienced engineers applying GxP and ISO 9001 principles, providing more than documentation—you gain assurance your systems are compliant and ready for audits.
Flexible qualification options can be tailored to your lab’s regulatory requirements and workload, ensuring your instruments consistently meet the highest standards of compliance and performance.
Contact Nautilus Precision today to schedule your IQ/OQ/PQ qualification services. Reach out now to keep your lab compliant, confident, and audit-ready.
Simple Tips for Instrument Qualification
Start with the Right Documentation
Have OEM manuals, calibration certificates, and previous service records on hand before qualification begins.Follow the IQ/OQ/PQ Framework
Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) as needed.Use Certified Standards
Run tests with traceable calibration standards to confirm accuracy and reliability. Avoid using expired or unverified materials.Confirm Environmental Conditions
Record room temperature, humidity, and power stability — all can affect qualification results.Test Under Real Sample Conditions
Validate the instrument not only with standards but also with representative samples to ensure practical performance.Verify Software and Firmware Versions
Make sure all versions match your validation plan and are recorded for compliance.Document Every Step
Log test results, acceptance criteria, and deviations. Sign and date all qualification records for audit readiness.Train Operators
Ensure all users understand startup, shutdown, and calibration procedures to maintain qualification status.Requalify After Major Changes
Repeat OQ/PQ whenever a system is moved, repaired, or updated to maintain compliance.
