Inspection Readiness

What’s Included

• 90-day diagnostic gap assessment. A structured review across FDA’s own CPGM 7356.002 inspection zones, including a 15-minute document retrieval standard — testing whether your organization can produce what an investigator asks for as fast as an investigator expects it.
• Evidence assembly and CAPA log review. Building the 60-to-31-day phase around a systematic review of open CAPAs, with a defined threshold for flagging any CAPA approaching a 90-day extended-timeline justification.
• Mock FDA inspection stress-test. Running a final 30-day phase that simulates the inspection itself — front-room and back-room coordination, document production under time pressure, and investigator-style questioning — rather than a document review alone.
• 24-point Inspection Readiness Index scoring. Scoring readiness across six categories — document control and retrieval, CAPA system, annual product review, equipment and facilities qualification, batch record integrity, and front-room/back-room readiness — against defined bands from Inspection-Ready to High Risk, so readiness is a number you can track, not an impression.
• Front-room/back-room protocol design. Establishing who talks to the investigator, who researches and verifies information in the back room, and how information moves between them without contradicting itself in real time.

When You Need This

• You have an inspection window coming and don’t have a structured way to know, today, whether your site would score as Inspection-Ready or as having Systemic Deficiencies.
• Your CAPA log has items open long enough that they’d require an extended-timeline justification, and you need to know that before an investigator does.
• You’ve never run a mock inspection and aren’t confident your front-room and back-room teams would stay coordinated under real time pressure.

Readiness isn’t a feeling — it’s a score across specific categories, checked against a specific timeline. Request an assessment and we’ll tell you where your site sits on the Inspection Readiness Index today, and what closes the gap before the investigator arrives.