Compliance Builder

Compliance Builder Overview

For pharmaceutical companies operating in controlled GxP environments, making sure that all systems remain in 21 CFR Part 11 compliance is not just important – it’s imperative. With Compliance Builder;s capabilities and comprehensive security features, such as user access control, data security, , and a central data archive; companies can prevent unauthorized use, including file/data deletion or modification, collect electronic signatures and capture granular audit trails over all IT sub-systems. Those commonly used Excel files will no longer pose a challenge to reconstruct the change history and compliance risk of improperly vetted changes and authorizations.

Compliance Builder is a One-Stop Solution for Monitoring Business-critical Information and Systems.

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.

Additional features of Compliance Builder that promote CFR Part 11 compliance include:

· Comprehensive Application Security Statistics

· Full Audit Trail

· Validation-Ready Platform

· Configurable Electronic Signatures

Real-time Database Compliance Monitoring

Compliance Builder includes built-in modules for monitoring files, databases, and SharePoint sites. Our database monitoring module allows you to manage and control any RDBMS-based system, including SQL-based applications, batch systems, and custom-developed database applications.

Our real-time database module facilitates monitoring all files Subject to 21 CFR part 11 regulations.

With the Compliance Builder database module, you can:

· Monitor changes in database tables, recording each change event and maintaining an archive of all changed records.

· Configure the system to issue and route data change notifications.

· Monitor data changes using various parameters with an easy-to-use, menu-driven user interface.

· Require authenticated acknowledgments and sign-offs.

Real-time File Compliance Monitoring

Our out-of-the-box file monitoring module facilitates monitoring files subject to 21 CFR Part 11 regulations.

With the Compliance Builder File Compliance module, you can:

· Import existing data from any file-based system

· Revision management for file updates and edits

· Quickly integrate desktop applications with legacy data sources

· Facilitate compliance with 21 CFR Part 11

· Provide clear and consistent audit trail of GxP data files without complicated integrations

Reporting

With Compliance Builder, you get customizable reports that allow you to manage your business. Reports display data in both summary and detailed format for audited File and RDBMS activity. Report filters allow your quality team to only display audited activity on selected files, folders, or database tables and fields and provides comparison tools to show data changes between versions.

Contact us for more information: sales@xybion.com