RegCheck

RegCheck™ Process

Application Structure

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Features a User-Friendly Checklist Format

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Checklists are automatically assigned based on the type of study

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Users are led through the review process by choosing topics from point-and-click
menus and entering text

Identifies, Categorizes and Prioritizes Deficiencies

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Reports are generated that flag deficiencies, including any studies that need to be
amended or repeated

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Deficiencies are prioritized into critical (red), major (blue) and minor (green)
categories

Provides Required or Suggested Corrective Actions

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All issues identified are paired with required or suggested corrective actions that are
linked to current specific FDA standards

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Audit trail of all entries facilitates discussion of corrective actions