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®
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).
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.