Qualification services

Comprehensive instrument qualification services to help laboratories meet compliance requirements

Helping labs meet regulatory requirements

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 instrument. 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.

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Instrument qualification service offerings

	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

Instrument qualification service details

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 a signed, audit-ready, digital document.

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Data sheet PDF < 1 MB

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View FDA regulatory guidance

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

	Illumina qualification service	Instrument installation	Preventive maintenance
Tests for proper installation	checkmark Icon not available	checkmark Icon not available
Provides certificate of tool calibration (upon customer request)	checkmark Icon not available
Provides installation checklist or PM certificate		checkmark Icon not available	checkmark Icon not available
Provides certificate of maintenance inspection & pass/fail justification			checkmark Icon not available
Evidence of passing criteria is available in associated instrument output files	checkmark Icon not available
Provides engineer training certificate upon customer request	checkmark Icon not available
Provides signed, digital certificate of qualification upon customer request	checkmark Icon not available
Delivers a signed, audit-ready, digital document	checkmark Icon not available
Helps comply with US FDA/GxP predicate rules and 21 CFR §58.63 Subpart D, ISO 17025, ISO 15189, and others	checkmark Icon not available
Provides 10-year document archive of procedure	checkmark Icon not available

How to order qualification services

Interested in our instrument 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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Qualification services

Helping labs meet regulatory requirements

Instrument qualification service offerings

Instrument qualification service details

View FDA regulatory guidance

How to order qualification services

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Qualification services

Helping labs meet regulatory requirements

Instrument qualification service offerings

Instrument qualification service details

View FDA regulatory guidance

College of American Pathologists (CAP) Laboratory General Checklist

How to order qualification services

Related solutions

Illumina NGS & microarray training

Molecular diagnostics

Illumina Proactive instrument performance service

Speak to a specialist