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Audit Functions

Critical Compliance Certainty

Shouldn't audit trails be robust? Of course. And most technology companies have some fairly decent ones. But shouldn't they also be comprehensive, easy to access, and easy to use? How about delivering useful information for both compliance and corrective action as needed? Does your current solution provide that? Many don't.

Each MedNet ENLIGHTEN^TM eClinical Solution comes complete with very robust Audit Functions that are fully compliant with regulatory requirements, and deliver real-time reporting into the hands of the people that need it most - anywhere, anytime.

Imagine being able to quickly and easily identify specific data changes by filtering the entire database by date, time, user, form, site and field. This is exactly what you can do, in a matter of seconds, with just a few clicks of a mouse, using the Detailed Field Audit report. Prefer analyzing a single form at a time? Use the Form Change Log to review all changes ever made to a form including old/new values, and date/time/user stamping.

Worried about forms being unlocked and altered? Check the Unlocked Forms Audit to see a 21CFR11-compliant report of who, what, where, when, and why. If you're concerned about certain individuals' activities within the system, the User Activity Audit will detail their actions, complete with times, dates and originating IP addresses. And at the Website Portal level, both the IP Address Audit and the Web Site Sign On Audit provide information on site-specific access to your studies.

A comprehensive package of 6 major audit tools, MedNet's ENLIGHTEN Audit Functions give you the insights, ease of use and peace of mind you've been looking for.

Key Features

• Complete audit functionality provided through:
  
  • Detailed Field Audit
    
  • Form Change Log
    
  • Unlocked Forms Audit
    
  • User Activity Audit
    
  • IP Address Audit
    
  • Web Site Sign On Audit
    
• Audit functionality varies by tool, but often includes:
  
  • Date / time / user stamping
    
  • Filtering
    
  • Sorting
    
  • Field names
    
  • Old / new values
    
  • Drill-down hyperlinks
    
  • Export capabilities

Key Benefits

• Delivers real-time information via easy-to-use tools
  
• Simplifies troubleshooting and data management activities
  
• Ensures compliance with FDA and GCP requirements