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:
- Installed correctly
- Meets its design requirements and specifications
- 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 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
The Cost
of
Mistakes
Delivering new products to market is challenging. And it is difficult to see the cost impact of one or more mistakes.
Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.