Secondary inspection aligned with FDA harmonization

Legacy lines don’t fail quietly.

FDA citations, inspections, Form 483s, and solid-dose recalls show where quality risk concentrates. With FDA harmonization accelerating, expectations are rising across global supply chains. It is now possible to add secondary inspection oversight that helps mitigate quality risk while preserving existing validated lines and operating expense models.

Explore the national trendlines below, then see how Fulcrym helps teams identify and manage potential escape risk on legacy processes.

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Explore the system

Pick a lane. Each page is built to answer one question cleanly.

How it works

What Sentinel does, how it fits in-line, and how decisions are reviewed.

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Value proposition

ROI model, payback timeline, and executive-ready financial framing.

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Learn: inspection escapes

Where inspection escapes happen most often and what causes them.

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White paper

Long-form technical framing and the sentinel approach to secondary inspection.

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Use cases

Match the concept to the reality of your line and your constraints.

Secondary inspection

Add a second layer that catches what slips through without ripping up the line.

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Legacy lines

Improve safety and confidence where replacing equipment is not an option.

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Escape risk reduction

Focus on ambiguity, escalation, and traceability to reduce surprises.

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