Compliance monitoring with a multi-lingual support
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 (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.
Some of the exciting new key features in Compliance Builder 10.0 (Data Integrity Software)
- Multi-lingual Support:
Multi-lingual support 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:
Special functionality is added to prevent files from being accidentally or intentionally deleted by users while accessing the directories through a Secure Application feature.
- Audit Trail:
The newly added filters in CB v10.0 help customers generate an audit report 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.The event history report has been enhanced for applications which are accessed through a Secure Application feature that includes login/log out and login failure events.
- Access Control:
The modified access control feature allows only a designated and authorized CB user to sign off events in a reconciliation report. In the current version, only designated users (such as Admin) can sign off on reconciliation reports.
- 21 CFR Part 11 Compliance:
For enhanced 21 CFR Part 11 compliance, a feature has been added to configure the meaning of e-signatures for data events through Picklist. The existing feature allowing free text entry for sign off comments continues to be available. This can be monitored through audit trail to prevent super users (like Admin) from changing the choice of Picklist later. In addition, specific features 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 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