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.

What is Installation Qualification


What should be included in installation qualification?

Installation qualification (IQ) protocol for equipment includes checking for proper location, proper energy supply and acceptable environmental conditions. It also includes checking of contents against the packing list, verifying software installation, documenting computer-controlled instrumentation, verifying connections with peripherals, and recording calibration and validation dates.

*Source: https://www.thefdagroup.com

What is operational qualification?

Operational qualification, according to the FDA, is establishing confidence that process equipment and subsystems can consistently operate within stated limits and tolerances.

*Source: http://www.ofnisystems.com

What is design qualification?

Design qualification demonstrates that the design or selection of the equipment meets user requirements. It documents that equipment considerations were included in design controls and the equipment requirements were identified prior to purchasing.

*Source: https://www.orielstat.com

FDA Software Validation

One hurdle medical device companies overcome is validating that their quality system can ensure compliance with applicable regulatory standards and requirements. Read more about validation and how it should plays a role in selecting your Cloud QMS solution.