Comprehensive qualification services to help labs meet compliance requirements

Qualification Services

At Illumina, we understand the changing regulatory landscape and strive to provide solutions to help our customers comply with standards and regulations. It’s important for laboratories to maintain compliance by adopting well-documented qualification protocols for their Illumina instruments.

To develop our Installation and Operational Qualification and Performance Qualification (IQ/OQ/PQ) Services, we carefully conducted numerous experiments for each Illumina system. These procedures tested and validated each critical component, set cut-off metrics, and verified these metrics to confirm operation and performance in accordance with Illumina specifications.

Compliance Services
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 report.
  • After 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
  • 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 system 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

Illumina Qualification Services offer more than conventional preventive maintenance (PM) or system health checks. They help make sure that your sequencer is installed and operating according to manufacturer specifications and provide an audit ready report.

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View Data Sheet
FDA Regulatory Guidance

Visit the US Food and Drug Administration website for further guidance on 21 CFR §58.63 Subpart D.

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College of American Pathologists (CAP) Laboratory General Checklist

As part of the CAP Accreditation Program, the College of American Pathologists (CAP) Laboratory General Checklist recommends that labs perform functional checks and performance verifications to confirm that an instrument operates according to specifications. These checks are required at certain intervals, including upon installation, before routine use, and after repair or adjustments. For details and additional guidance, refer to the CAP Laboratory General Checklist.

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Laboratory General Checklist
  Illumina Qualification Service Instrument Installation Preventive Maintenance
Tests for proper installation      
Provides certificate of tool calibration      
Provides installation checklist or PM certificate      
Provides certificate of maintenance inspection & pass/fail justification      
Provides report with evidence of passing criteria      
Provides engineer training certificate      
Provides watermarked & signed certificate of qualification      
Delivers audit-ready report      
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      

Interested in our qualification services? Explore service ordering options, or contact us if you have questions. We’ll help you select the right service for your needs.

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