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IQ/OQ Services, QIAcube

For qualification of QIAcube instruments
  • Comprehensive IQ/OQ documentation
  • Template sheets for run documentation
  • IQ/OQ performed in accordance with cGMP
  • Highly trained team of Instrument Service Specialists
  • All costs covered including labor and travel
The IQ/OQ Service product provides Installation Qualification and full documentation for QIAcube owners. After installation, instrument performance is tested to demonstrate that the instrument meets the operational specifications as defined by the manufacturer, and this is documented in the Operational Qualification document. Approximately 80 standardized, qualification performance tests are performed in accordance with ISO 9001 and cGMP requirements, ensuring compliance with the instrument owner's quality assurance system.
Cat No./ID: 9241465
IQ/OQ Services, QIAcube
Validation support service for the QIAcube includes IQ/OQ documentation, performance of the qualification protocols, and costs for labor and travel
The QIAcube is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube for the applications described in the kit handbooks.
Principle

Installation Qualification (IQ) and Operational Qualification (OQ) form part of the laboratory validation process for regulatory compliance. IQ/OQ services support ISO 9001 quality management systems and CLIA, GLP, and GMP method performance requirements.

IQ provides verification and documentation of:

Accessories and supplies
User documents
Site requirements
Hardware installation
Software configuration

OQ provides verification and documentation of:

System setup
Installation test
Temperature tests
Test run
Qualification tests

In summary, IQ/OQ services provide:

Declaration of conformity
Official signatures
Lists of test equipment and deviations
Deviation report form
Operator training

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Safety Data Sheets (1)
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