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.

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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


Electronic Signatures

Disable Function at user & Domain Level


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


File Type

File Server

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