real-time PCR Installation Qualification, Operational Qualification (IQ OQ) PACKAGE for azure cielo

The Azure Biosystems® IQOQ package (AIQ317) is an essential tool for verifying any Cielo Real-Time PCR System. The validation package contains the documentation required for regulatory compliance, SOPs, and laboratory management. It includes the protocols, checklists, and certificates necessary to satisfy your validation requirements. This IQ OQ Documentation Package includes the protocols, checklist and logbook, and certificates necessary to satisfy your validation requirements. The simple-to-follow instructions and durable checklist and logbook will assist you in performing the necessary tests and maintaining accurate records. There is also an add-on option to have the IQ OQ service performed by Azure Biosystems personnel.

    Features

    • Detailed procedures for Installation Qualification (IQ) and Operational Qualification (OQ)
    • For use with any Cielo Real-Time PCR system
    • Easy-to-use checklists with clear instructions

    Package includes:

    • Detailed procedures for Installation Qualification (IQ) and Operational Qualification (OQ),
    • Checklist and logbook,
    • Certificates.

    Package does not include::

    • IQ OQ Service (AIQ316), sold separately
    • Validation Plate (AIQ318), sold separately

    IQOQ phases for Cielo

    1. Installation Qualification (IQ)

    During IQ phase, the equipment is inspected to ensure it meets the requirements of Azure Biosystems and has been installed properly.

    Includes:

    • Examining equipment design and supplied documentation
    • Assuring that the work area has the required space for the system to operate at peak performance
    • Determining installation parameters
    • Identifying required environmental controls and procedures
    • Installing the device
    • Verifying correct installment of the device
    • Establishing the procedures for monitoring, operating, and control of the device including responsible operators

    2. Operational Qualification (OQ)

    OQ phase tests the newly installed device to ensure it operates as expected and gauges the conditions under which it will continue to do so. Test runs will determine that the system is operating as expected. If OQ is successful, it will validate that the device is operating at optimal performance.

    Includes:

    • Validating system internal diagnostics
    • Validating application operations

    Ordering

    Part NumberProduct Name
    AIQ318Azure Cielo IQ OQ qPCR Validation PlateREQUEST A QUOTE
    AIQ316Azure Cielo IQ OQ ServiceREQUEST A QUOTE
    AIQ317Azure Cielo IQ OQ DocumentationREQUEST A QUOTE

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