Illumina Operational Qualification

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

Overview

Illumina Operational Qualification (OQ) service follows a comprehensive, well-defined protocol to verify each system functions according to pre-set and validated operational specifications. Critical aspects of the OQ include motion qualification, optics qualification, fluidics qualification, and thermal qualification. 

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

  • Delivers an audit-ready signed OQ report 

  • Verifies system performs according to manufacturer specifications during install and after major repairs, relocation, or system software upgrades 

  • Ensures up-to-date protocols following each instrument hardware and software release 

  • Provides engineer training and tool calibration certificates (upon customer request)  


Specifications

Documentation

Product literature

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Instrument Qualification Service Offerings

Qualification Service Service Description Qualification Recommended Intervals Event-Specific Service
Installation Qualification (IQ) Provides documented verification that the instrument is installed according to our specifications and safety regulations. During the IQ, a trained engineer confirms that the latest supported firmware and software versions were installed, verifies instrument setup and accessory logistics, checks that physical and environmental safety conditions are met, and provides a signed, audit-ready, digital document.
  • During initial installation
  • After relocation and reinstallation
  • Before first-time use
  • After general changes to lab environment (eg, remodeling, construction, electrical disruptions)
Operational Qualification (OQ) Follows a comprehensive, well-defined protocol to make sure that the system is functioning according to our preset and validated operational specifications. The OQ protocol was developed and validated in Illumina labs and is updated after each instrument hardware and software release, so you receive the most up-to-date service. Critical aspects of the OQ include motion, optics, fluidics, and thermal qualifications
  • During initial installation
  • After a reactive service, software upgrade, or preventive maintenance
  • Periodically, according to lab standard operating procedure
  • With an IQ to test for baseline level of instrument performance
  • Before starting a major study or experiments
Performance Qualification (PQ) Follows a comprehensive, well-defined protocol to make sure that the instrument is functioning according to our preset and validated performance specifications. The PQ protocol was developed and validated in Illumina labs and is updated after each instrument hardware and software release, so you receive the most up-to-date service. Critical aspects of the PQ include a PhiX data run (including projected yield total), data quality, and any additional comments. After any qualified major repair After maintenance, replacement, or upgrade of selected modules

What's Included

  Illumina Qualification Service Instrument Installation Preventive Maintenance
Tests for proper installation
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Provides certificate of tool calibration (upon customer request)
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Provides installation checklist or PM certificate  
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Provides certificate of maintenance inspection & pass/fail justification    
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Evidence of passing criteria is available in associated instrument output files
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Provides engineer training certificate upon customer request
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Provides signed, digital certificate of qualification upon customer request
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Delivers a signed, audit-ready, digital document
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Helps comply with US FDA/GxP predicate rules and 21 CFR §58.63 Subpart D, ISO 17025, ISO 15189, and others
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Provides 10-year document archive of procedure
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For further guidance on next-generation sequencing–based genetic testing, visit the US FDA website.

iScan services (1)

iScan® Operational Qualification

SP-301-1002

Verifies that the iScan System 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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MiniSeq services (1)

MiniSeq Operational Qualification

20004136

Verifies that the MiniSeq Sequencing System is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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MiSeq services (2)

MiSeq Operational Qualification

SP-103-1002

Verifies that the MiSeq System is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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MiSeqDx™ Operational Qualification

SP-503-1002

Verifies that the MiSeqDx Instrument is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq services (2)

NextSeq® 500 Operational Qualification

SP-104-1002

Verifies that the NextSeq 500 Sequencing System is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq 550 Dx Operational Qualification

20023610

Verifies that the NextSeq 550Dx instrument is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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NovaSeq services (1)

NovaSeq® 6000 Operational Qualification

20016098

Verifies that the NovaSeq 6000 Sequencing System is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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