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Real-Time Compliance Monitoring Software to Ensure Data Integrity – v10.0

Xybion’s CB 10.0 to facilitate real-time compliance monitoring with a multi-lingual support feature

Xybion Corporation’s upgraded ComplianceBuilder™  v10.0, enhances and facilitates real-time compliance monitoring 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 being monitored through 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 key Features in Compliance Builder® 10.0 (Data Integrity Software)

  • Multi-lingual support functionality is one of the best-added features of the new version, where a simplified Chinese language pack is included with CB 10.0. Other language packs can be added on demand.
  • Special functionality is added to prevent files from being deleted by users (accidentally/intentionally) while accessing the directories through a Secure Application feature within ComplianceBuilder 10.0.
  • A special feature is added to allow the designated users to receive email on Sign-off Timeout events, thus helping in generating a reconciliation report.

The newly added filters to CB v10.0 will help customer generate audit report based on specific data events, such as data creation, data deletion or data modification. In addition, 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.

Further, the event history report is enhanced for applications accessed through a Secure Application feature to include login, log out and login failure events as well.

  • The modified access control feature will allow only a designated and authorized CB user to sign off events in a reconciliation report. In the current version, any user, such as Admin can sign off on reconciliation report which is now modified only to designated users.

For enhanced 21 CFR Part 11 Compliance, a feature is added to configure the meaning of e-signature for data events through picklist. However, the existing feature allowing free text entry for sign off comments continues to be available.

Further, this can be monitored through audit trail as well to prevent super user like Admin from changing the choice of picklist later. In addition, the specific features will allow the CB Admin to allow or prevent users from changing domain user password though CB.

a. 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

b. Operating System Versions where support continued, and new versions added:

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

c. Browsers where support continued, and new versions added:

  • Google Chrome
  • Explorer 11
  • Internet Explorer 10

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