Order the NovaSeq X Series
Advanced chemistry, optics, and informatics combine to deliver exceptional speed and data quality, outstanding throughput and scalability.
Verify instrument operation and obtain a digital, audit-ready document from certified Illumina engineers to help meet regulatory requirements.
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:
Instruments | MiSeq System, MiSeqDx Instrument, iSeq 100 System, NextSeq 550 System, NextSeq 550Dx Instrument, NextSeq 2000 System, NextSeq 1000 System, MiSeqDx in Research Mode, MiniSeq System, NextSeq 550Dx in Research Mode, NovaSeq X System, NovaSeq 6000Dx in Research Mode, NextSeq 500 System, iScan System, NovaSeq 6000 System, MiSeq FGx System, NovaSeq X Plus System |
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Service type | Operational qualification |
Technology | Microarray, Sequencing |
Qualification Service | Service Description | Qualification Recommended Intervals | Event-Specific Service |
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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. |
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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 |
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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 |
Illumina Qualification Service | Instrument Installation | Preventive Maintenance | |
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Tests for proper installation | checkmark
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Provides certificate of tool calibration (upon customer request) | checkmark
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Provides installation checklist or PM certificate | checkmark
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Provides certificate of maintenance inspection & pass/fail justification | checkmark
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Evidence of passing criteria is available in associated instrument output files | checkmark
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Provides engineer training certificate upon customer request | checkmark
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Provides signed, digital certificate of qualification upon customer request | checkmark
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Delivers a signed, audit-ready, digital document | checkmark
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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 | checkmark
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Provides 10-year document archive of procedure | checkmark
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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 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 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 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® 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® 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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