Comprehensive Qualification Services from Illumina
Illumina Performance Qualification (PQ) 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 PQ service follows a comprehensive, well-defined protocol to verify the system functions according to pre-set and validated performance specifications. We update the PQ protocol following each instrument hardware and software release, ensuring your laboratory receives the most up-to-date service. Critical aspects of the PQ include a PhiX data run with projected yield total and data quality.
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, PQ helps research and diagnostic genomic laboratories meet regulatory guidelines:
Provides an audit-ready signed PQ report
Verifies Illumina sequencers are performing according to manufacturer specifications, following a successful PhiX run
Helps establish instrument log files for change control
Provides engineer training and tool calibration certificates (upon customer request)
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 are installed; verifies instrument setup and accessory logistics, checks physical and environmental safety conditions are met, and provides a signed audit-ready report.
Follows a comprehensive well-defined protocol aimed to ensure the system is functioning according to our pre-set and validated operational specifications. The OQ protocol was developed and validated internally and is updated following each instrument hardware and software release ensuring the laboratory is receiving the most up-to-date service. Critical aspects of the OQ include but are not limited to: motion qualification, optics qualification, fluidics qualification, and thermal qualification.
After a reactive service, software upgrade, or preventive maintenance
Periodically, according to lab standard operating procedure
Performance Qualification (PQ)
Follows a comprehensive, well-defined protocol to ensure the system is functioning according to our pre-set and validated performance specifications. The PQ protocol is developed and validated internally and is updated following each instrument hardware and software release. This ensures the laboratory is receiving the most up-to-date service. Critical aspects of the PQ include: PhiX data run including projected yield total, data quality, and comments.