ComplianceBuilder - 21 CFR Part 11 Compliance Monitoring Software

ComplianceBuilder™ is a real-time monitoring solution designed to enable 21 CFR Part 11 compliance. ComplianceBuilder (CB) is a mature, proven, and fully configurable real-time compliance monitoring software solution which provides 21 CFR Part 11 compliance across IT subsystems. By generating the audit trail and enabling electronic signatures, ComplianceBuilder allows you to securely track changes across all IT subsystems including file systems, databases, laboratory, or manufacturing process equipment. It can be configured to monitor any file-based system for changes including additions, deletions, and file modifications.

To enable data integrity, CB enhances the security of the applications to a new level through a security wrapper that can be placed around the application and file storage area. ComplianceBuilder offers complete flexibility in establishing your managed folder criteria by specific directory, workstation, file type, or file server.

Upon detecting a file change, ComplianceBuilder stores the file revision in a unique, secure data repository for ready retrieval of revision history. ComplianceBuilder provides complete flexibility to configure the system to monitor based on customer’s business rules to enable functionality such as managing eSignatures, user sign-offs or even setting up email alerts with no impact or interference to any application performance.

Additional security features such as user access control, data security, full audit trail, and a central data archive enable customers to prevent unauthorized use including file/data deletion or modification. ComplianceBuilder is offered in different license models based on customer’s need to manage compliance in one system, across multiple sites, or the enterprise – be it a file system (any file type including Word, Excel or any data file) or a database such as SQL Server, Oracle, or MS Access, or any instrument (Instron, UV-VIS, Special Microscope, Chemstation etc.). ComplianceBuilder truly helps as one-stop solution to remediate compliance challenges across the organization.

21 CFR Part 11 Compliance Software

The FDA defines data integrity as a key component of CFR Part 11 compliance to ensure every electronic record has completeness, consistency, and accuracy of data. Data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).


ALCOA Data Integrity Software

All of the elements of the acronym ALCOA are supported by ComplianceBuilder for ensuring data integrity. Serving as evidence of the events that took place during any data collection activity which complies with regulations, thereby justifying that the data is safe and effective.

Additional features that promote Part 11 compliance include:

  • Comprehensive Application Security:
    A comprehensive application security layer integrates seamlessly into your existing security infrastructure, controlling both user administration and access to raw data. Layered security levels allow you to control access at both the application and file levels. Features include sign-off authorization and security enabling full enterprise compliance.
  • Full Audit Trail:
    A detailed audit trail records changes made to file-based systems, databases, and laboratory equipment. File-based systems perform full retrieval and comparison of file revisions, including spreadsheets, Word documents, text, and PDF files.
  • Configurable Electronic Signatures:
    For e-signatures, three levels of interaction are supported, including; 1) Silent, 2) Acknowledgement, and 3) Signature Confirmation.
  • Validation-Ready Platform:
    Xybion offers a comprehensive set of IQ/OQ documentation to support implementation and validation. Further, Xybion can provide comprehensive services to specifically customize validation documentation to meet customer’s unique business requirements.
  • Microsoft® SharePoint Monitoring and Fraud Detection
    This is a new module of ComplianceBuilder which provides capabilities designed to monitor the SharePoint library and send the appropriate notifications if document downloads from the configured library exceed the specified time period. Upon fraud detection, an alert email is distributed to mitigate risk and allow for appropriate action from stakeholders.

Out-of-the-Box Functionality Includes:

  • Audit Trail
  • Compare Feature added to File Audit Trail Report
  • Electronic Signatures
  • Dashboards
  • Email Notifications
  • Database Monitoring
  • Alerts
  • Version History
  • Controlled User Access
  • Disable function at User and Domain level
  • Screen Lock is implemented as part of CBAgent
  • Spreadsheet Validation
  • Audit Schema Structure (DDL)
  • Microsoft Access integration
  • System Clock Change Notification
  • Multi-Platform Support, including Microsoft SharePoint Server, Microsoft SharePoint, Oracle Databases, and Microsoft SQL Databases


ComplianceBuilder enables organizations to monitor and enable 21 CFR Part 11 compliance reducing enterprise regulatory risk. Features such as full audit trails, electronic signatures, and maintaining revision history enable organizations to reduce or minimize compliance risks for critical file-based systems, databases, and laboratory equipment. Layered security features enable you to promote compliance with internal business practices and operating procedures – critical for companies operating in controlled GxP environments. As a flexible platform, ComplianceBuilder provides a best-in-class solution for monitoring business-critical information and systems, including:

ComplianceBuilder v10.0

Real-Time Compliance Monitoring Software To Ensure Data Integrity

Facilitate real-time compliance monitoring with a multilingual support feature

Xybion Corporation’s upgraded ComplianceBuilder v10.0 enhances and facilitates real-time compliance monitoring software services with improved access control, audit trail, and multi-language support features (supporting Mandarin), thus enabling global Life Science organizations to leverage new business opportunities.

The new version will prevent any data loss due to accidental/intentional file deletion by users when directories are 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 is generated automatically for login/log out with session duration information when the screen lock functionality is used. Here, the user is allowed to perform reconciliation of an event sign-off timeout through an added feature of ComplianceBuilder v10.0. The additional features of CB v10.0 will enable organizations to enhance the monitoring and tracking of 21 CFR Part 11 compliance, reducing enterprise regulatory risk.

Some of the exciting new features in ComplianceBuilder 10.0:

  • Multilingual Support:
    Multilingual support functionality is one of the best added features of the new version, where a simplified Chinese language pack is included with CB v10.0. Other language packs can be added on demand.
  • File Deletion Control:
    Special functionality is added to prevent files from being accidentally or intentionally deleted by users while accessing the directories through a Secure Application feature within ComplianceBuilder v10.0.
  • Audit Trail:
    The newly added filters in CB v10.0 will help customers generate audit reports based on specific data events such as data creation, deletion, or modification. The latest version allows the user to generate an audit report during the login/log out session with duration information when the screen lock functionality is used. In addition, the event history report is enhanced for applications accessed through a Secure Application feature including login/log out and login failure.
  • Access Control:
    The modified access control feature will allow only a designated and authorized CB user to sign off on events in a reconciliation report. In the current version, any user, such as Admin can sign off on reconciliation reports which is now modified only to designated users.
  • 21 CFR Part 11 Compliance:
    For enhanced 21 CFR Part 11 compliance, a feature has been added to configure the meaning of e-signature for data events through Picklist. The existing feature allowing free text entry for sign-off comments continues to be available. This can also be monitored through audit trail to prevent super users like Admin from changing the choice of Picklist later. In addition, the specific features will enable the CB Admin to allow or prevent users from changing domain user passwords though CB.

Added support for new releases of OS and Database

Database versions where support continued, and new versions were 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 were added:

  • Windows Server 2016
  • Standard Windows Server 2012R
  • Windows 10
  • Windows 7

Browsers where support continued, and new versions were added:

  • Google Chrome
  • Explorer 11
  • Internet Explorer 10