Illumina Performance Qualification

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

Overview

Illumina Performance Qualification (PQ) 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. Illumina PQ services follow comprehensive, well-defined, and up-to-date protocols to verify each system functions according to pre-set and validated performance specifications. 

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, PQ helps research and diagnostic genomic laboratories meet regulatory guidelines:

  • Delivers an audit-ready signed PQ report

  • Verifies Illumina sequencers are performing according to manufacturer specifications, following a successful PhiX run

  • Helps establish instrument log files for change control

  • Provides engineer training and tool calibration certificates (upon customer request)


Specifications

Documentation

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Compare PQ to other qualification services

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

HiSeq and cBot services (5)

HiSeq® 2500 Installation and Operational Qualification

SP-102-2506

Verifies that the HiSeq 2500 Sequencing System has been delivered, installed, and is operating as intended according to manufacturer specifications. Appropriate documentation is provided.

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HiSeq® 3000 Performance Qualification

SP-102-3003

Performance Qualification (PQ) verifies and provides documented proof that the instrument has been operating as intended and according to manufacturer specifications. It is required by many national and international regulations and quality standards. It is recommended after a Preventative Maintenance, a major repair, or at a fixed schedule defined by laboratory Standard Operating Procedures.

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HiSeq® 4000 Performance Qualification

SP-102-4003

Verifies that the HiSeq 4000 Sequencing System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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HiSeq X™ Performance Qualification

SP-102-1103

Verifies that the HiSeq X Sequencing System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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HiSeq® 2500 Performance Qualification

SP-102-2503

Verifies that the HiSeq 2500 Sequencing System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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iSeq services (1)

iSeq 100 Installation, Operational, and Performance Qualification

20023612

Verifies that the iSeq 100 Sequencing System has been delivered, installed, and is operating and performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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MiniSeq services (1)

MiniSeq Performance Qualification

20004545

Verifies that the MiniSeq Sequencing System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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MiSeq services (2)

MiSeq Performance Qualification

SP-103-1003

Verifies that the MiSeq System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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MiSeq Dx Performance Qualification (PQ)

20025873

Verifies that the MiSeqDx Instrument is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq services (3)

NextSeq 500 PQ

SP-104-1003

Verifies that the NextSeq 500 Sequencing System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq 550 Performance Qualification

SP-104-5503

Verifies that the NextSeq 550 System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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NextSeq 550 Dx Performance Qualification (PQ)

20025872

Verifies that the NextSeq 550Dx instrument is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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NovaSeq services (1)

NovaSeq® 6000 Performance Qualification

20016332

Verifies that the NovaSeq 6000 Sequencing System is performing as intended according to manufacturer specifications. Appropriate documentation is provided.

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