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.
As regulatory guidelines continue to evolve and increase in stringency, laboratories need well-documented system qualification protocols for compliance. Performed by Illumina-trained and -certified engineers, OQ helps research and diagnostic genomic laboratories meet regulatory guidelines:
|Qualification Service||Service Description||Qualification Recommended Intervals||Event-Specific Service|
|Installation Qualification (IQ)||Provides documented verification that the instrument is installed according to our specifications and safety regulations. During the IQ, a trained engineer confirms that the latest supported firmware and software versions were installed, verifies instrument setup and accessory logistics, checks that physical and environmental safety conditions are met, and provides a signed, audit-ready, digital document.||
|Operational Qualification (OQ)||Follows a comprehensive, well-defined protocol to make sure that the system is functioning according to our preset and validated operational specifications. The OQ protocol was developed and validated in Illumina labs and is updated after each instrument hardware and software release, so you receive the most up-to-date service. Critical aspects of the OQ include motion, optics, fluidics, and thermal qualifications||
|Performance Qualification (PQ)||Follows a comprehensive, well-defined protocol to make sure that the instrument is functioning according to our preset and validated performance specifications. The PQ protocol was developed and validated in Illumina labs and is updated after each instrument hardware and software release, so you receive the most up-to-date service. Critical aspects of the PQ include a PhiX data run (including projected yield total), data quality, and any additional comments.||After any qualified major repair||After maintenance, replacement, or upgrade of selected modules|
|Illumina Qualification Service||Instrument Installation||Preventive Maintenance|
|Tests for proper installation|
|Provides certificate of tool calibration (upon customer request)|
|Provides installation checklist or PM certificate|
|Provides certificate of maintenance inspection & pass/fail justification|
|Evidence of passing criteria is available in associated instrument output files|
|Provides engineer training certificate upon customer request|
|Provides signed, digital certificate of qualification upon customer request|
|Delivers a signed, audit-ready, digital document|
|Helps comply with US FDA/GxP predicate rules and 21 CFR §58.63 Subpart D, ISO 17025, ISO 15189, and others|
|Provides 10-year document archive of procedure|
For further guidance on next-generation sequencing–based genetic testing, visit the US FDA website.
A dedicated support section is not currently available for this product