RegCheck™ Features

Utilizes a proven process developed by regulatory professionals

Resides in a secure, private cloud and is accessed using any standard internet browser

Assigns user-friendly checklists based on the type of study and provides an audit trail based on each user’s unique log-in

Checklist elements are annotated to 21 CFR and guidance documents for easy reference

Provides thorough program status updates throughout drug development

Generates real-time reports that:

Flag and prioritize deficiencies into critical (red), major (blue) and minor (green) categories

List deficiencies with required or suggested corrective actions

Identify studies that may need to be repeated or amended and areas requiring additional explanation or information

Note missing and/or illegible pages so that they may be handled efficiently

Provide confirmation that documentation is complete