ComplianceBuilder™ is a real-time monitoring solution designed to enable 21 CFR Part 11 compliance. ComplianceBuilder (CB) is a mature, proven, and fully configurable real-time compliance monitoring software solution which provides 21 CFR Part 11 compliance across IT subsystems. By generating the audit trail and enabling electronic signatures, ComplianceBuilder allows you to securely track changes across all IT subsystems including file systems, databases, laboratory, or manufacturing process equipment. It can be configured to monitor any file-based system for changes including additions, deletions, and file modifications.
To enable data integrity, CB enhances the security of the applications to a new level through a security wrapper that can be placed around the application and file storage area. ComplianceBuilder offers complete flexibility in establishing your managed folder criteria by specific directory, workstation, file type, or file server.
Upon detecting a file change, ComplianceBuilder stores the file revision in a unique, secure data repository for ready retrieval of revision history. ComplianceBuilder provides complete flexibility to configure the system to monitor based on customer’s business rules to enable functionality such as managing eSignatures, user sign-offs or even setting up email alerts with no impact or interference to any application performance.
Additional security features such as user access control, data security, full audit trail, and a central data archive enable customers to prevent unauthorized use including file/data deletion or modification. ComplianceBuilder is offered in different license models based on customer’s need to manage compliance in one system, across multiple sites, or the enterprise – be it a file system (any file type including Word, Excel or any data file) or a database such as SQL Server, Oracle, or MS Access, or any instrument (Instron, UV-VIS, Special Microscope, Chemstation etc.). ComplianceBuilder truly helps as one-stop solution to remediate compliance challenges across the organization.