Xybion Corporation’s upgraded Compliance Builder v11.0 enhances and facilitates real-time compliance monitoring services with improved access control, audit trail, file security, and multi-language support features (including Mandarin), thus enabling global life science organizations to leverage new business opportunities.
The new version helps to prevent 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 designated applications and authorized users access to critical digital data.
In addition to the e-signature facilities the new version shall provide a means for Review and Approval of all actions performed by instrument operators. All reports have been updated to generate in PDF format as well, all of which can be digitally signed and maintained by the system further eliminating the need for paper records.
Application security has been enhanced to ensure only properly trained operators may utilize instrument software secured by Compliance Builder. Any unauthorized attempts to access a workstation or secured application will be recorded.
The additional features of CB v11.0 enable organizations to enhance the monitoring and tracking of 21 CFR Part 11 compliance, reducing enterprise regulatory risk.
