Integrated Compliance Software

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.

 

 

 

ComplianceBuilder™ is designed to meet the regulatory requirements set out by 21 CFR § 11, SOX and other regulations by securing and 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. Click the Thumb to view a full size screenshot
     
     

 

 

 

 

 

 

 

ComplianceBuilder 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

 

Key Platform Features Include

 

Multi-Platform Support

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

 

21 CFR PART 11 Compliance

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).

 

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 Compliance Builder in highly regulated systems environments.  We offer comprehensive services to specifically customize validation documentation to meet your unique business requirements. 

 

 

 

 

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on Compliance Builder