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Compliance Software for File and Database Monitoring

ComplianceBuilder is a compliance software solution designed to provide real-time monitoring of 21CFR Part 11 compliance for any device, machine, file, application or computer system.

REAL TIME COMPLIANCE MONITORING SOFTWARE

ComplianceBuilder is a flexible compliance software solution designed to provide real-time monitoring of 21 CFR Part 11. By generating audit trails and providing configurable electronic signatures, ComplianceBuilder allows you to securely track changes across all IT subsystems including file systems, databases and laboratory equipment. It can be configured to monitor any file-based system for changes, including additions, deletions, and file modifications. This is accomplished through a security wrapper that can be placed around the application and file storage area and by monitoring file changes, including file creation, deletion or modification. ComplianceBuilder™ offers complete flexibility in establishing your managed folder criteria by specific director, workstation, file type, or file server.

Upon detecting a file change, ComplianceBuilder™ stores the file version in a unique, secure data repository for ready retrieval.  Events are configured to your business rules, allowing you to manage eSignatures, user sign-offs and alarms with no impact to application performance.

Additional security features, such as user access control, data security, full audit trail and a central data archive, enable you to prevent unauthorized use, including file/data deletion or modification. Offered as an on-premise or cloud-based solution, ComplianceBuilder™ enables immediate benefit by improving visibility into your total compliance risk.

21 CFR PART 11 Compliance:

ComplianceBuilder™ supports robust 21 CFR Part 11 compliance. The system records all actions in an independent, secure audit trail. Changes (additions, edits and deletions) are immediately reported for any authorized user prompted for a 21 CFR Part 11-compliant approval signature.  The system also captures electronic signatures from authorized workstations and, in accordance with Part 11 requirements, provides device and authority checks that limit access to authorized personnel. In addition, ComplianceBuilder™ supports biometric and non-biometric signatures (including PKI).

Additional features that promote Part 11 compliance include:

  • Comprehensive Application Security. A comprehensive application security layer integrates seamlessly into your existing security infrastructure, controlling both user administration and access to raw data. Layered security levels allow you to control access at both the application and file levels. Features such as sign-off authorization and Public Key Infrastructure (PKI) support add additional layers of security, enabling full enterprise compliance.
  • Full Audit Trail. A detailed audit trail records changes made to file-based systems, databases, and laboratory equipment. For file-based systems, perform full retrieval and comparison of file revisions, including spreadsheets, Word documents, text files, and PDF files.
  • Configurable Electronic Signatures. For e-signatures, three levels of interaction are supported, including 1) Silent, 2) Acknowledgement, and 3) Signature Confirmation.
  • Validation-Ready Platform. Xybion offers a comprehensive set of validation documentation templates and SOPs to support the implementation and deployment of ComplianceBuilder™ in highly regulated systems environments.  We offer comprehensive services to specifically customize validation documentation to meet your unique business requirements.
  • Microsoft® SharePoint Monitoring and Fraud Detection. ComplianceBuilder provides capabilities designed to monitor the SharePoint library and send the appropriate notifications if document downloads from the configured library exceed the specified time period. Upon fraud detection, an alert email is distributed to mitigate risk and allow for appropriate action from stakeholders.

Out-of-the-Box Functionality Includes:

  • Audit Trail
  • Electronic Signatures
  • Dashboards
  • Email Notifications
  • Database monitoring
  • Alerts
  • Version History
  • Controlled User Access
  • Spreadsheet Validation
  • Audit Schema Structure (DDL)
  • Multi-Platform Support, including Microsoft® SharePoint Server®, Microsoft®
  • SharePoint, Oracle Databases, and Microsoft® SQL Databases.

Benefits:

ComplianceBuilderTM enables organizations to monitor and track compliance with 21 CFR Part 11 in real time, reducing enterprise regulatory risk. Features such as full audit trails and workflow-based electronic signatures enable organizations to reduce or minimize compliance risks for critical file-based systems, databases, and laboratory equipment. Layered security features enable you to promote compliance with internal business practices and operating procedures, critical for companies operating in controlled GxP environments. As a flexible platform, ComplianceBuilder provides a best-in-class solution for monitoring business critical information and systems, including:

  • Files On Your Workstations Or Files Servers
  • Tables In Your Databases
  • Process And Manufacturing Equipment