By: Xybion  09-12-2011

In today’s regulatory environment, change management is an essential requirement.  Organizations must have the ability to maintain their systems and monitor changes to ensure sustained compliance.  Common approaches to address these challenges sometimes includes file polling.  This is very inefficient and can often miss certain changes if timestamps and other attributes are not modified.

ComplianceBuilder™ is a unique application that monitors 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.


Compliance Builder offers complete flexibility in establishing your managed folder criteria by specific director, workstation, file type, or file server.  Compliance Builder is designed to monitor key data sources such as:

   Files On Your Workstations Or Files Servers

   Tables In Your Databases

   Process And Manufacturing Equipment


Compliance builder is offered on multiple platforms including Microsoft® SharePoint Server®


Compliance Builder is a cost effective solution that 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 authority checks that limit access to authorized personnel. ComplianceBuilder supports biometric and non-biometric signatures (including PKI).


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


Xybion offers a comprehensive set of validation documentation templates and SOPs to support the implementation and deployment of Compliance Builder in highly regulated systems environments.  We offer comprehensive services to specifically customize validation documentation to meet your unique business requirements.

Other products and services from Xybion



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Xybion offers a comprehensive portfolio of enterprise-ready products designed to help organizations effectively manage key business processes, drive efficiency, and ensure compliance with global regulations. Our applications leverage the latest advanced technology to ensure compatibility within your current technology environment. As a result of recent acquisitions, our portfolio has expanded to include enterprise GRC and Maximo product suite.


VitalPath Suite

Federated Content Management The Vital Path Suite™ specifically addresses organization’s need to integrate disparate content repositories with a single records management policy engine by creating a gateway to various repositories. The Vital Path Suite™ allows you to take full advantage of SharePoint’s collaborative content management capabilities and and make your SharePoint solution part of your overall enterprise content strategy.