Real-Time Compliance Monitoring Software
Designed to enable 21 CFR Part 11 compliance, providing data integrity across IT systems such as file systems, database systems, laboratory or manufacturing instruments.
Trusted by the Most Reputable Brands in the World
ALCOA Data Integration
The FDA requires that all data submitted to the administration is reliable and accurate. Compliance Builder supports all elements of the acronym ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) to ensure data integrity.
Out-of-the-Box Functionality
Audit Trail
Alerts & Email Notifications
Access Control
Database
Monitoring
Electronic Signatures
Disable Function at user & Domain Level
Dashboard
Version History &
File Deletion Control
Support for Any Size Program
Compliance Builder is offered in different license models. We’ll help you select the version that works best based on whether you need to manage compliance in one system, across multiple sites, or an entire enterprise — whether it is on a file system (any file type including Word, Excel, or any data file), a database such as SQL Server, Oracle or MS Access, or any instrument (Instron, UV-VIS, Special Microscope, Chemstation, and more).
Top-Notch Application Security
Compliance Builder brings application security to a new level through a security wrapper that is placed around the application and file storage area. The software offers complete flexibility in establishing managed folder criteria by:
Specific Directory
Workstation
File Type
File Server
Superior Audit Trails
