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Ensure Data Integrity and 21 CFR Part 11 Compliance
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.
Superior Audit Trails
By generating an audit trail and enabling electronic signatures, Compliance Builder serves as an audit management system that allows you to securely track changes across all IT subsystems including:
Upon detecting a file change, Compliance Builder stores the file revision in a unique, secure data repository for ready retrieval of revision history.
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
Out-Of-The-Box Functionality
Audit Trail
Alerts & Email Notifications
Access Control
Database
Monitoring
Electronic Signatures
Disable Function at user and 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).
Compliance Builder 10.0
Real-Time Compliance Monitoring Software that Ensures Data Integrity
Xybion Corporation’s upgraded Compliance Builder v10.0 enhances and facilitates real-time compliance monitoring services with improved access control, audit trail, and multi-language support features (including Mandarin), thus enabling global life science organizations to leverage new business opportunities.
The new version prevents any data loss due to accidental/intentional file deletion by users when directories are being monitored through the File Deletion Control feature. Further, this functionality is supported by modified Access Control which allows only a designated and authorized user to close the events with enhanced e-signature facilities.
An audit report with session duration information is automatically generated by login/log out activity when the screen lock functionality is used. This allows the user to perform reconciliation of an event sign-off timeout.
The additional features of CB v10.0 enable organizations to enhance the monitoring and tracking of 21 CFR Part 11 compliance, reducing enterprise regulatory risk.
key features in Compliance Builder 10.0 (Data Integrity Software)
Multilingual Support
Multi-lingual functionality is one of the best new features of CB 10.0. A simplified Chinese language pack is included and other language packs can be added on demand.
File Deletion Control
Prevent files from being accidentally or intentionally deleted by users while accessing the directories through a Secure Application feature.
Audit Trail
Generate an audit report based on specific data events, such as data creation, deletion, or modification and with login/log out session with duration information.
21 CFR Part 11
Configure the meaning of e-signatures for data events through Picklist. This can be monitored through audit trail to prevent super users (like Admin) from changing the choice of Picklist later.
Additional support for new releases on Operating System (OS) and Databases
Database Versions where support continued, and new versions added:
- Oracle 12c
- Oracle 11g
- MS SQL Server 2016
- MS SQL Server 2014
- MS Access 2010
- MS Access 2013
- MS Access 2016
Operating System Versions where support continued, and new versions added:
- Windows server 2016
- Standard Windows server 2012R
- Windows 10
- Windows 7
Browsers where support continued, and new versions added:
- Google Chrome
- Explorer 11
- Internet Explorer 10
ALCOA 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
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.
- Require authenticated acknowledgements and sign-offs.
- Monitor data changes using various parameters with an easy to use, menu-driven user-interface.
Audit tables and notifications
For each database table, Compliance Builder:
- 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
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. Commonly monitored file types include:
- Configuration Files
- Excel Spreadsheets
- 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
“Being able to track the lifecycle of desired files has repeatedly enabled my team to quickly resolve discrepancies saving valuable time in file forensics work and in documentation.”
- Client Feedback
Key Features Of Compliance Builder’s File Monitoring Module
Upon detecting a file change, Compliance Builder stores the file revision in a unique, secure data repository for ready retrieval of revision history.
File Version Comparison Tools
File Change Notifications
Browse Folders
Field Version Tracking
Flexible Managed Folders
Intuitive Folder Manager
Audit Trail Report
Mutli-Platform Support
Real-time SharePoint Compliance Monitoring
If your organization relies on Microsoft SharePoint for enterprise storage of critical business data and associated files, Compliance Builder can help you achieve CFR Part 11 compliance and reduce operational risks by enabling detection of abnormal activities.
With the Compliance Builder SharePoint module, you can:
Reduce Risk
Gather information stored in SharePoint and report on download activity for highly sensitive files.
Detect Fraud
Act on information quickly and prevent the misuse of critical information in SharePoint with real-time email alerts.
Increase Compliance
Prevent SharePoint users from exceeding the maximum number of downloads and monitor unusual activities via automated reporting features.
Easy Configuration Process
Compliance Builder enables you to monitor and audit SharePoint libraries. The SharePoint server configuration page enables you to configure the system to gather information regarding download activity and receive email alerts when threshold limits are exceeded.
Compliance Builder supports SharePoint versions 2007 and above and does not require installation on the SharePoint server. The software is seamlessly integrated with your routine IT ecosystem.
