How Inspection Ready works
Pick your industry: medical devices, food, dietary supplements, or seafood and juice HACCP. An AI investigator opens the visit the way a real one does, then asks up to ten questions about your quality system and the records behind it. Vague answers get a follow-up; specific, evidence-based answers move the visit on. When an answer shows a real gap, it goes on a mock Form 483. At close-out you get a readiness score, any observations with a guide to fixing each one, and coaching on your weaker answers.
What the investigator knows
The investigator works from the current rules: the QMSR (21 CFR 820) for medical devices, 21 CFR 117 and FSVP for food, 21 CFR 111 for dietary supplements, and 21 CFR 123 and 120 for seafood and juice HACCP. Every observation it can write maps to a real citation in our FDA 483 Citations library, with a guide to what investigators look for and how to fix it. The company is fictional, so please don't enter confidential information.
Want to know where your own system stands? Try the free QMS gap check.