Xybion Corporation

Xybion provides a total compliance and quality management solution for companies operating in heavily regulated industries.  As part of our total solution, we offer ComplianceBuilder, a unique solution that helps companies ensure they are properly monitoring all files, databases, and equipment in accordance with 21CFR Part 11 and other regulations. ComplianceBuilder™ provides real-time visibility and information security across your entire information enterprise.

Xybion’s comprehensive suite of GRC solutions allow organization to safeguard employee, partner, and customer information.  Organizational boundaries continue to evolve as we now work in a collaborative environment to drive innovation at a quicker pace and lower cost of ownership.  Identity information is now layered in Big Data virtual repositories and it is critical to maintain control of whom and how it is accessed.  Xybion’s GRC solutions are used by organizations that are most vulnerable to intrusion and identity theft.  Xybion GRC solutions support healthcare, US government, transportation, energy and shipping industries.  Xybion can help modernize the current identity management information architecture or simply augment existing systems to provide the required safeguards.

For access governance Xybion gives you the visibility and control necessary to:

• Understand what you have in your environment and who has access to it.
• Empower business managers to understand what employee entitlements actually mean and certify access accordingly.
• Establish a continuous process to ensure that every individual has the right access to do their job, nothing more.
• Establish the business processes, workflows and a systematic approach to managing critical events that impact employee, partner, and customer information.

Ask how Xybion can assist in solving identity management challenges.  In many cases, Xybion has been able to simply augment the systems that are currently in place.

ComplianceBuilder™ File (CB-File)

CB-File allows you to import existing data from laboratory instrument files, Microsoft Excel spreadsheets, and Microsoft Word documents or any other file based system. CB-File helps you quickly integrate your desktop applications with your legacy data sources, while at the same time helping you achieve 21 CFR § 11 compliance.

CB-File Detects and Monitors the followng:

• Configuration Files
• Excel Spreadsheets
• Word Document Files
• Text Files
• PDF Files
• Graphic Files
• Recipe Files
• Lab Instrument Data Files
• PLC Programs
• Access Databases
• SAS Data Sets

ComplianceBuilder File Features

File Version Comparison Plug-ins You can install application-specific plug-ins that enable CB / File’s “Compare” functionality. You just choose the two files you want to compare, and CB / File will generate a comparison report highlighting the files’ differences. Plug-ins are available for Microsoft Excel and Word, and for any text file. Multi-Platform Support. Additional application-specific plug-ins can be developed and delivered to suit your specific requirements.

Key Features

File Change Notifications occur whenever a file is added, modified or deleted in a managed directory. CB / File then issues a notification that pops up in the CB Agent window on a designated user's workstation. You can specify whether notification sign-off is required, and how long CB / File should wait before it “times out” an unacknowledged notification.

Browse Folders using your designated file-based systems for file changes: adds, deletes and modifications. Upon detecting a file change, CB / File stores the file version in a secure Data Repository. You have complete flexibility in setting up your “Managed Folders” file-monitoring program: by specific directory, by workstation or file server, or by file type. CB / File’s Folder Manager page displays managed files and file versions in a Windows-like hierarchy. You can view or download any file, display file attributes, or run the File Compare option.

File Audit Trail Report displays file changes in managed directories according to your report selection criteria: by folder, file name(s), sign-off workstation or a date/time range.

ComplianceBuilder Audit Trail Report displays changes made to your managed directories’ configuration and set up over a specified time period.