Illumina Operational Qualification

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

HiSeq® 2500 Operational Qualification

SP-102-2502

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HiSeq 3000 Operational Qualification

SP-102-3002

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HiSeq 4000 Operational Qualification

SP-102-4002

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HiSeq X™ Operational Qualification

SP-102-1102

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cBot™ Operational Qualification

SP-101-1002

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iScan Services

iScan® Operational Qualification

SP-301-1002

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iSeq Services

iSeq 100 Installation and Operational Qualification

20023611

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MiniSeq Services

MiniSeq Operational Qualification

20004136

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MiSeq Services

MiSeq® Operational Qualification

SP-103-1002

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MiSeqDx™ Operational Qualification

SP-503-1002

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NextSeq Services

NextSeq® 500 Operational Qualification

SP-104-1002

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NextSeq 550 Dx Operational Qualification

20023610

Price
 
 

NovaSeq Services

NovaSeq® 6000 Operational Qualification

20016098

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Product Highlights

Comprehensive Qualification Services from Illumina

Illumina Operational Qualification (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 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.

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:

  • Provides an audit-ready signed OQ report
  • 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) 
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

Frequently Purchased Together

Specifications

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

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

Manuals and Support Information

A dedicated support section is not currently available for this product

Related Products

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 requirements.


Illumina Performance Qualification

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