Description
Overview
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:
Delivers an audit-ready signed OQ report
Verifies system performs according to manufacturer specifications during install and after major repairs, relocation, or system software upgrades
Ensures up-to-date protocols following each instrument hardware and software release
Provides engineer training and tool calibration certificates (upon customer request)
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Qualification Service: Service Description
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
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.
Illumina Qualification Service: Instrument Installation
Tests for proper installation: checkmark
Provides certificate of tool calibration (upon customer request): checkmark
Provides installation checklist or PM certificate: checkmark
Provides certificate of maintenance inspection & pass/fail justification: checkmark
Evidence of passing criteria is available in associated instrument output files: checkmark
Provides engineer training certificate upon customer request: checkmark
Provides signed, digital certificate of qualification upon customer request: checkmark
Delivers a signed, audit-ready, digital document: checkmark
Helps comply with US FDA/GxP predicate rules and 21 CFR §58.63 Subpart D, ISO 17025, ISO 15189, and others: checkmark
Provides 10-year document archive of procedure: checkmark
iScan® Operational Qualification
SP-301-1002
Verifies that the iScan System is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
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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. View less
MiniSeq Operational Qualification
20004136
Verifies that the MiniSeq Sequencing System is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
MiSeq Operational Qualification
SP-103-1002
Verifies that the MiSeq System is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
MiSeqDx™ Operational Qualification
SP-503-1002
Verifies that the MiSeqDx Instrument is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
NextSeq® 500/550 Operational Qualification
SP-104-1002
Verifies that the NextSeq 500 Sequencing System is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
NextSeq 550 Dx Operational Qualification
20023610
Verifies that the NextSeq 550Dx instrument is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
NovaSeq® 6000 Operational Qualification
20016098
Verifies that the NovaSeq 6000 Sequencing System is operating as intended according to manufacturer specifications. Appropriate documentation is provided. View less
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