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File Monitoring

Real Time Compliance Monitoring Software for Files

ComplianceBuilder™ File Monitoring (CB-File) is a module within ComplianceBuilder™ that facilitates the monitoring of files that are subject to 21 CFR Part 11 constraints.  CB-File allows you to import existing data from laboratory instrument files, Microsoft® Excel spreadsheets, Microsoft® Word documents, or any other file based system. CB-File helps you quickly integrate your desktop applications with legacy data sources, while at the same time facilitating compliance with 21 CFR Part 11.

CB-File monitors the following file types:

  • 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
  • Any file-based system

“Being able to track the life-cycle of desired files has repeatedly enabled my team to quickly resolve discrepancies saving valuable time in file forensics work and in documentation.” 

– Feedback from a ComplianceBuilder™ User

Key Features

  • File Version Comparison Plug-ins. Application-specific plug-ins can be utilized which enable CB-File’s “Compare” functionality. Simply choose the two files you want to compare, and CB-File generates a comparison report highlighting the differences in the files. Plug-ins are available for Microsoft® Excel, Microsoft ®Word, and any text file.
  • Multi-Platform Support. Additional application-specific plug-ins can be developed and delivered to suit your specific requirements.
  • File Change Notifications occur whenever a file is added, modified or deleted in a managed directory. CB-File then issues a notification that appears 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, including additions, deletions, and modifications.
  • File Version Tracking. Upon detecting a file change, CB-File stores the file version in a secure Data Repository.
  • Flexible Managed Folders. 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.
  • Intuitive Folder Manager. 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.
  • Audit Trail Report. The 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. It also displays changes made to your managed directories’ configuration set up over a specified time period.
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