Below is an excerpt from FDA’s General Principles of Software Validation; Final Guidance for Industry and FDA Staff.The IQ/OQ/PQ terminology was initially borrowed from the process/equipment validation area when that was the device/biologics/pharma industry's only frame of reference for validation. Over the years, FDA and of industry have come to better understand software and acknowledged that the IQ, OQ, PQ terminology can be difficult to map to software validation. The terms verification and validation apply much more directly and are what is
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Verification and validation apply directly to Grand Avenue Software (GAS) and are the terms used in our validation package.
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