Illumina Performance Qualification

Verify instrument performance and obtain an audit-ready PQ report from certified Illumina engineers to help meet regulatory requirements. Read More...
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HiSeq and cBot Services

HiSeq® 2500 Installation and Operational Qualification

SP-102-2506

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HiSeq® 3000 Performance Qualification

SP-102-3003

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HiSeq® 4000 Performance Qualification

SP-102-4003

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HiSeq X™ Performance Qualification

SP-102-1103

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iSeq Services

iSeq 100 Installation, Operational, and Performance Qualification

20023612

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MiniSeq Services

MiniSeq Performance Qualification

20004545

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MiSeq Services

MiSeq® Performance Qualification

SP-103-1003

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MiSeq FGx™ Performance Qualification

SP-106-1003

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NextSeq Services

NextSeq® 550 Performance Qualification

SP-104-5503

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NovaSeq Services

NovaSeq® 6000 Performance Qualification

20016332

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Product Highlights

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) 
Compare PQ to Other Qualification Services
Qualification Service Service Description Recommended Intervals
Installation Qualification (IQ) 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.
  • After initial installation
  • After relocation and re-installation
Operational Qualification (OQ) 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.
  • After any qualified major repair

Specifications

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Illumina Operational Qualification

Verify instrument operation and obtain an audit-ready report from certified Illumina engineers to help meet regulatory requirements.


Instrument Installation Qualification and Operational Qualification (IQ/OQ)

Verify instrument installation and operation, and obtain an audit-ready report from certified Illumina engineers to help meet regulatory requirements.