Investigator Access to IRT Audit Log Data in a Secure, GxP Compliant Platform
What is Audit Data Management?
To maintain data oversight and ensure integrity, Health Authority guidelines require IRT audit log data to come directly to investigators without sponsors handling or managing the data in the process. To meet this requirement, IRT vendors must facilitate Investigator access to system audit logs post study close, outside the IRT system.
Driven by this new regulatory guidance and industry need, Endpoint Clinical and partner, Egnyte™, have created the Audit Data Management platform – a validated IRT system integration that extracts IRT transaction audit log data for each site and provides these data files to Investigators directly in a GXP-compliant and secure platform. Thus, ensuring Investigators have the data they need to meet regulatory expectations.
Benefits of Audit Data Management:
- Ensure GXP Compliance
- Access Secure Data Easily
- Maintain Data Integrity and Oversight
- Access and report historic data
Features of Audit Data Management:
- Secure login prevents unauthorized access to confidential data.
- Easily traceable data gives valuable insight into file transactions- when they occurred, file details, and user information.
- Robust reporting provides access to historic audit logs, user activity and workflow transactions.