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. Read More...
Select Product(s)

HiSeq 3000 IQ/OQ

SP-102-3006

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HiSeq 4000 IQ/OQ

SP-102-4006

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MiSeq IQ/OQ

SP-103-1006

Price
 
 

MiSeqDx IQ/OQ

SP-503-1006

Price
 
 

NextSeq 500 IQ/OQ

SP-104-1006

Price
 
 

cBot IQ/OQ

SP-101-1006

Price
 
 

HiSeq X IQ/OQ

SP-102-1106

Price
 
 

HiSeq 2500 IQ/OQ

SP-102-2506

Price
 
 

NextSeq 550 IQ/OQ

SP-104-5506

Price
 
 

NextSeq 550Dx IQ/OQ

20023559

Price
 
 

NovaSeq 6000 IQ/OQ

20016100

Price
 
 

cBot 2 IQ/OQ

SP-101-2006

Price
 
 

iScan IQ/OQ

SP-301-1006

Price
 
 

MiniSeq IQ/OQ

20004138

Price
 
 

Product Highlights

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 Installation and Operational Qualification (IQ/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 IQ service 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 were installed; verifies instrument setup and accessory logistics, checks physical and environmental safety conditions are met, and provides a signed audit-ready report.

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, IQ/OQ helps research and diagnostic genomic laboratories meet regulatory guidelines:

  • Provides an audit-ready signed IQ/OQ report
  • Accelerates use by ensuring the Illumina instrument is installed, operational, and ready to use after initial delivery
  • 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) 
Compare Service Types
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

 

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      

Visit the US FDA website for further guidance on next-generation sequencing–based genetic testing here.

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Related Products

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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.


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Illumina Performance Qualification

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