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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

Instruments MiSeq System, MiSeqDx Instrument, iSeq 100 System, NextSeq 550 System, NextSeq 550Dx Instrument, NextSeq 2000 System, NextSeq 1000 System, MiSeqDx in Research Mode, MiniSeq System, NextSeq 550Dx in Research Mode, NovaSeq X System, NovaSeq 6000Dx in Research Mode, NextSeq 500 System, iScan System, NovaSeq 6000 System, NovaSeq X Plus System
Service type Operational qualification, Installation qualification
Technology Microarray, Sequencing

Documentation

Product literature
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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

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Tool calibration certificate

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Installation checklist or PM certificate  

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Maintenance inspection certificate and pass/fail justification    

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Report with evidence of passing criteria

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Engineer training certificate

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Watermarked and signed qualification certificate

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Audit-ready report

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

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Procedure document archived 10 years

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

NovaSeq services (2)

NovaSeq® 6000 Installation and Operational Qualification

20016100

Verifies that the NovaSeq 6000 Sequencing System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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NovaSeq 6000Dx Installation and Operational Qualification

20072467

Installation Qualification (IQ) and Operation Qualification (OQ) provides documented proof that the instrument has been delivered, installed, and operating as intended and according to manufacturer specifications. It is required by many regulations and quality standards. It is recommended at initial installation, after relocation, or before start of regulated use.

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NextSeq services (4)

NextSeq 550 Installation and Operational Qualification

SP-104-5506

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

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NextSeq 550 Dx Installation and Operational Qualification

20023559

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

20040651

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

20040670

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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MiSeq services (2)

MiSeq Installation and Operational Qualification

SP-103-1006

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

SP-503-1006

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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MiniSeq services (1)

MiniSeq Installation and Operational Qualification

20004138

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)

iSeq 100 Installation and Operational Qualification

20023611

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)

iScan® Installation and Operational Qualification

SP-301-1006

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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