File Monitoring Software

Real Time Compliance Monitoring Software for Files

ComplianceBuilder™ File Monitoring Software (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, 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 lifecycle 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, 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: Use 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, 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.