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 Operational Qualification (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 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, OQ helps research and diagnostic genomic laboratories meet regulatory guidelines:
- Provides an audit-ready signed OQ report
- 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)