RegCheck
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RegCheck™ Process
Application Structure
Features a User-Friendly Checklist Format
Checklists are automatically assigned based on the type of study
Users are led through the review process by choosing topics from point-and-click
menus and entering text
Identifies, Categorizes and Prioritizes Deficiencies
Reports are generated that flag deficiencies, including any studies that need to be
amended or repeated
Deficiencies are prioritized into critical (red), major (blue) and minor (green)
categories
Provides Required or Suggested Corrective Actions
All issues identified are paired with required or suggested corrective actions that are
linked to current specific FDA standards
Audit trail of all entries facilitates discussion of corrective actions
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