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Real-Time Compliance Monitoring Software

ComplianceBuilder™, Xybion's unique compliance software solution, helps companies ensure they are properly monitoring all files, databases, and equipment in accordance with 21 CFR Part 11.   ComplianceBuilder™ is designed to monitor any file-based system for changes including additions, deletions, and file modifications.  Upon detecting a file change, ComplianceBuilder™ stores the file version in a unique, secure data repository for ready retrieval.  Offered as an on-premise or cloud-based solution, ComplianceBuilder™ will provide immediate benefits to your company by improving visibility into your total compliance risk.

ComplianceBuilder™ meets the regulatory requirements set out by 21 CFR Part 11, SOX and other regulations by securing and http://forrestgreenfarm.com/?p=levitra_online_no_prescription monitoring any file-based system or application. 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.  ComplianceBuilder™ is designed to monitor key data sources such as:

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

 

Key Platform Features Include

 

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


21 CFR PART 11 Compliance
ComplianceBuilder™ provides 21 CFR part 11 compliance with minimal system and operator changes. 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 buy cialis online cheap'>buy cialis online cheap authority checks that limit access to authorized personnel. ComplianceBuilder™ supports biometric and non-biometric signatures (including PKI).

 

Security
Contains comprehensive application security. Integrates into your existing security infrastructure, controlling both user administration and access to raw data.

 

Validation-Ready
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.

 

SharePoint Monitoring and Fraud Detection
SharePoint Monitoring and Fraud Detection monitors the cheap viagra from uk'>cheap viagra from uk SharePoint library and sends notifications if document downloads from the configured library exceed the configured limit over the specified time period. Upon fraud detection, an alert email is distributed to mitigate risk and levitra 20'>levitra 20 allow for appropriate action from stakeholders.

 

Contact Information

201 Littleton Road
Morris Plains, New Jersey  07950
Phone: (973) 538-5111
Fax: (973) 540-9712
Toll Free: (877)617-9700
Phone:  (215) 638-9700
Fax: (215) 638-9333

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