Instrument Installation Qualification and Operational Qualification (IQ/OQ)

Verify instrument installation and operation, and obtain a digital, audit-ready document from certified Illumina engineers to help meet regulatory guidelines.

Overview

Comprehensive qualification services from Illumina

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, Illumina Installation and Operational Qualification (IQ/OQ) services help research and diagnostic genomic laboratories meet these regulatory guidelines.  

IQ/OQ services perform numerous experiments for each system to ensure critical components are tested and validated, set cut-off metrics, and confirm these metrics show the system is operating in accordance with Illumina specifications. IQ/OQ service:

  • Provides a signed, audit-ready, digital OQ document 

  • Accelerates use by ensuring the Illumina instrument is installed, operational, and ready to use after initial delivery 

  • Verifies Illumina sequencing systems perform according to manufacturer specifications after major repairs, relocation, or system software upgrades 

  • Delivers engineer training and tool calibration certificates upon customer request 


Specifications

Documentation

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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

What’s included

 

Illumina Qualification Service Instrument Installation Preventative Maintenance
Testing for proper installation

 
Tool calibration certificate

   
Installation checklist or PM certificate  

Maintenance inspection certificate and pass/fail justification    

Report with evidence of passing criteria

   
Engineer training certificate

   
Watermarked and signed qualification certificate

   
Audit-ready report

   
Supports compliance with US FDA/GxP predicate rules and 21 CFR §58.63, ISO 17025, ISO 15189

   
Procedure document archived 10 years

   

 

For further guidance on next-generation sequencing–based genetic testing, visit the US FDA website.

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NextSeq 550 Dx Installation and Operational Qualification

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Verifies that the NextSeq 550Dx instrument has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq 1000 Installation & Operational Qualification

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Verifies that the NextSeq 1000 Sequencing System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq 2000 Installation and Operational Qualification

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Verifies that the NextSeq 2000 Sequencing System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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Verifies that the MiSeq System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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MiSeqDx® Installation and Operational Qualification

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Verifies that the MiSeqDx Instrument has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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Verifies that the MiniSeq Sequencing System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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iSeq services (1)

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Verifies that the iSeq 100 Sequencing System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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iScan services (1)

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Verifies that the iScan System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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