What is Installation Qualification (IQ)?

Installation Qualification Definition

The FDA provides guidance applicable to the validation of medical device software or the validation of software that is used to design, develop, or manufacture medical devices. Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are the three independent and documented procedures used to validate that software is:

  1. Installed correctly
  2. Meets its design requirements and specifications
  3. Operates the way in which it was designed under load

The IQ records the installation of the software and ensures that the installation follows the correct steps.

FAQs

What is difference between OQ and PQ?

IQ content is being added. Stay tuned.

How do you write installation qualifications?

IQ content is being added. Stay tuned.

What is operational qualification?

IQ content is being added. Stay tuned.

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