Compliance Builder

Compliance Builder is a comprehensive compliance monitoring software crucial for pharmaceutical firms operating under GxP regulations to ensure 21 CFR Part 11 compliance. It aids in managing electronic document and signature control compliance across all IT subsystems with extensive security features like user access control, data security, audit trails, and a central data archive to prevent unauthorized usage.

The platform supports ALCOA principles, ensuring data integrity by being Attributable, Legible, Contemporaneous, Original, and Accurate, thereby safeguarding data against integrity compromises.

Key Features:

• Comprehensive application security
• Full audit trail capability
• Validation-ready platform
• Configurable electronic signatures

With real-time database compliance monitoring, Compliance Builder includes modules for supervising files, databases, and SharePoint. It supports any RDBMS, including SQL-based and custom-developed applications, facilitating CFR Part 11 compliance through real-time monitoring and data change notifications, using an easy menu-driven interface that requires authenticated acknowledgments.

Auditing is bolstered by creating audit tables for each database table, using triggers to track changes, and providing customizable reporting options that enable managing and monitoring RDBMS records. Reports are configurable to display selective data insights.

File and SharePoint Compliance:

The tool monitors an array of file types, from configuration files and spreadsheets to graphical files and lab instrument data. It is designed to handle any file type imaginable, ensuring thorough data management and protection.

For organizations using SharePoint, Compliance Builder ensures risk reduction and compliance via real-time email alerts and automated reporting features that prevent misuse of sensitive information by monitoring abnormal activities and download limits.

Compliance Builder's platform is compatible with various OS and database versions, including Oracle 12c, MS SQL Server 2016, and Windows 11, ensuring broad utility and adaptability in diverse IT environments.

Overall, the updated Compliance Builder v11.0 elevates real-time compliance monitoring, enhancing access control and data security processes, while supporting multilingual operations. This version also includes features like e-signatures, PDF report generation, and the File Deletion Control feature to mitigate data loss risks, thereby continuously reducing enterprise regulatory risk.