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IQ/OQ
Installation Qualification and Operational Qualification
As a leading provider of cell and gene therapy technologies, we understand the vital role of validating and documenting installation qualification and operational qualification to meet regulatory requirements.

To help you establish and maintain device compliance, Terumo BCT now provides a certified IQ/OQ protocol performed by our qualified professionals.

IQ/OQ


ESTABLISH AND MAINTAIN DEVICE COMPLIANCE

Installation qualification and operational qualification (IQ/OQ) services for Quantum.

Leverage our expertise and hands-on experience supporting our devices to supply you with audit-quality data certifiying compliance for your records.
  • Performed by professionals trained and qualified by Terumo BCT
  • Uses our established, comprehensive certification protocols — greatly reducing the burden of developing and performing your own IQ/OQ protocols
  • Verifies and documents that your equipment is operating as intended
  • Allows you to build a clear record of device operation throughout the life of your device, with periodic revalidation
WHAT'S INCLUDED? IQ TESTING OQ TESTING
  • Careful inspection of device functionality
  • On-site resolution of issues uncovered during the qualification process
  • Certification documentation for your records
Includes validation of:
  • Installation
  • Hardware
  • Software
  • Electrical safety and power mechanics
Includes validation of operational parameters, which includes:
  • Device software performance
  • Task performance
  • System component performance
  • Fluid movement performance
Disclaimer and warning: It is the user's responsibility to validate the safety and efficacy of the expanded cells for their intended application. Expanded cell products for use in human subjects must comply with all applicable country-specific regulatory requirements. IQ/OQ certification services provided by Terumo BCT on Quantum do not replace the user's responsibility to validate their overall process and the safety and efficacy of the resulting expanded cells.

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