Answer 5 quick questions about your equipment, process, or software system. We will tell you exactly which IQ, OQ, PQ, CSV, and other validation protocols apply, based on GHTF/SG3/N99-10:2004, FDA 21 CFR 820, and industry-specific regulatory requirements.
Free. No account required. Takes about 60 seconds.
Equipment qualification in regulated manufacturing follows a structured framework defined by GHTF/SG3/N99-10:2004 and enforced through regulations like FDA 21 CFR 820 and ISO 13485. The core qualification sequence (IQ, OQ, and PQ) applies to equipment that impacts product quality, but the specific protocols you need depend on what you are validating, its role in your process, and whether software is involved.
This tool evaluates your specific situation across five dimensions: system type, installation status, industry, product quality impact, and software presence. It then maps your answers to the applicable qualification and validation protocols per the GHTF framework and FDA guidance.
For software systems, CSV (Computer System Validation) or the newer CSA (Computer Software Assurance) framework applies per 21 CFR Part 11 and EU Annex 11. For processes that directly affect product quality, PPQ (Process Performance Qualification) and PV (Process Verification) may also be required. This quiz helps you identify exactly which protocols apply to your situation.
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