Comprehensive Qualification Services from Illumina
Regulatory guidelines for genomic research and diagnostics continue to evolve and increase in stringency. For compliance, laboratories need well-documented system qualification protocols.
Illumina Installation and Operational Qualification (IQ/OQ) services carry out numerous experiments for each system to ensure critical components are tested and validated, have cut-off metrics, and to confirm these metrics show the system is operating in accordance with specifications.
Our IQ service provides documented verification that instrument is installed according to our specifications and safety regulations. During the IQ, a trained engineer verifies latest supported firmware and software versions were installed; verifies instrument setup and accessory logistics, checks physical and environmental safety conditions are met, and provides a signed audit-ready report.
Our OQ service follows a comprehensive, well-defined protocol to verify the system functions according to pre-set and validated operational specifications. We update the OQ protocol following each instrument hardware and software release, ensuring your laboratory receives the most up-to-date service. Critical aspects of the OQ include motion qualification, optics qualification, fluidics qualification, and thermal qualification.
Performed by Illumina-trained and -certified engineers, IQ/OQ helps research and diagnostic genomic laboratories meet regulatory guidelines:
- Provides an audit-ready signed IQ/OQ report
- Accelerates use by ensuring the Illumina instrument is installed, operational, and ready to use after initial delivery
- Verifies Illumina sequencers perform according to manufacturer specifications after major repairs, relocation, or system software upgrades
- Helps establish instrument log files for change control
- Provides engineer training and tool calibration certificates (upon customer request)