Compliance Builder
Real-Time Compliance Monitoring Software
Ensure Data Integrity and 21 CFR Part 11 Compliance
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, you can seamlessly manage electronic document and signature control compliance across all IT sub-systems.
With comprehensive security features, such as user access control, data security, audit trails, and a central data archive, companies can prevent unauthorized use, including file/data deletion or modification.
Compliance Builder is a One-Stop Solution for Monitoring Business-critical Information and Systems.
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.
Data has always been important to life sciences companies involved in pharmaceutical manufacturing and research. The importance of data integrity is growing exponentially as regulatory requirements evolve. With Compliance Builder, you can safeguard your data and prove that it has not been compromised.
Compliance Builder lets you automatically conform to the principles of ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate).
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.
Audit tables and notifications
- Creates a corresponding audit table that mirrors the structure of the monitored table.
- Uses triggers to monitor target tables.
- Transfers data changes to audit tables.
- Sends notifications based on pre-configured rules.
- Provides a “recreate” function to ensure audit tables are recreated (preserving the old audit table) if the structure of the table being monitored changes.
Reporting
With Compliance Builder, you get customizable reports that allow you to manage your business. Reports display data from monitored RDBMS records in both summary and detailed formats. You can optionally configure reports to display only selected database tables or fields, or simply the old/new values of the data that was changed.
Real-time File Compliance Monitoring
Compliance Builder includes built-in modules for monitoring files, databases, and SharePoint sites. 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
- Quickly integrate desktop applications with legacy data sources
- Facilitate compliance with 21 CFR Part 11
Monitored File Types
Compliance Builder gives you the ability to manage sensitive company data and protect your most valuable data assets. When we say any file type, we mean it!
Compliance Builder is designed to monitor any type of file.
- Configuration Files
- Excel Spreadsheets
- Transfers data
- Word Documents
- Text files
- PDFs
- Graphic Files
- All Microsoft Files
- Recipe Files
- Lab Instrument
- Data Files
- PLC Programs
- Access Databases
- SAS Data Sets
- Any File-based System
- Databases
