IQ/OQ Services, QIAcube
For qualification of QIAcube instruments
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.
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.
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:
OQ provides verification and documentation of:
In summary, IQ/OQ services provide: