Illumina Operational Qualification

Verify instrument operation and obtain an audit-ready report from certified Illumina engineers to help meet regulatory requirements. Read More...
选择产品

HiSeq 2500 Operational Qualification

SP-102-2502

HiSeq 3000 OQ

SP-102-3002

HiSeq 4000 Operational Qualification

SP-102-4002

HiSeq X Operational Qualification

SP-102-1102

MiniSeq Operational Qualification

20004136

MiSeq Operational Qualification

SP-103-1002

MiSeq FGx Operational Qualification

SP-106-1002

MiSeqDx™ Operational Qualification

SP-503-1002

NextSeq 500 Operational Qualification

SP-104-1002

NextSeq 550Dx OQ

20023610

NovaSeq 6000 Operational Qualification

20016098

cBot Operational Qualification

SP-101-1002

iScan® Operational Qualification

SP-301-1002

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 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.

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) 
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

Frequently Purchased Together

 

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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仪器安装验收和运行验收(IQ/OQ)

lumina安装和运行验收(IQ/OQ)服务会对每个系统进行大量实验,确保重要的部件都经过了测试和验证,都有验收指标,并确认这些指标能够保证系统按质量标准运行。


Illumina Performance Qualification

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