Compliance Builder

Compliance Builder is a dedicated software designed for real-time compliance monitoring, enabling organizations to manage electronic document and signature control compliance seamlessly across all IT systems. It ensures adherence to 21 CFR Part 11 standards, maintaining data integrity and security across files, databases, and applications, ensuring accuracy, traceability, and audit readiness.

The software allows organizations to track data and changes across various file types, including Microsoft documents, graphics, lab instrumentation files, and SAS datasets, on any file-based system. This comprehensive solution helps teams examine file lifecycles in detail, ensuring compliance and data security at any scale.

As data security requirements become more stringent, large companies face challenges with outdated systems and fragmented processes. Compliance Builder addresses these challenges by being system-agnostic, integrating advanced compliance tools with legacy data systems, safeguarding archives, and extending the lifespan of existing infrastructure. It generates a robust chain of custody, creating complete audit-ready records that enhance compliance and data integrity.

Key Benefits

• Improved Compliance: Ensures 21 CFR Part 11 compliance, tracking data changes, downloads, and electronic signatures across diverse sources, including legacy databases, with complete chain of custody documentation.
• Enhanced Flexibility: Supports widely used file types and can be deployed within existing systems for simplified adaptability and long-term scalability.
• Robust Security: Protects sensitive data with layered access controls, real-time alerts, email notifications, and database monitoring to minimize risk and ensure data integrity.
• Greater Efficiency: Comes with validation documentation templates for rapid deployment, reducing the need for inefficient, error-prone manual work through computer-generated audit trails.

Core Features

Compliance Builder offers a suite of powerful features designed to protect data, support regulatory compliance, and adapt seamlessly to organizational needs.

• 21 CFR Part 11 Compliance: Records and secures all data events with audit trails and electronic signatures, reducing paper records while maintaining data integrity and regulatory adherence.
• Application Security: Integrates with existing security systems to control user access and protect raw data, with layered controls and file revision comparison capabilities.
• Configurable Electronic Signatures: Offers three levels of electronic signatures to align with internal policies.
• Database Monitoring & Audit Trail: Monitors structural and record changes across databases with full audit trails, using a Microsoft SharePoint® module to detect unusual activity.
• Configurable Security Options: Provides flexible security options, including electronic signatures and folder-level email alerts, without impacting application performance.

Compliance Builder is an all-in-one solution for organization-wide compliance, eliminating the need for multiple tools to meet diverse system and database requirements. It is system-agnostic and works with nearly any file type or database, including Oracle, SQL Server, and Microsoft Access. It compiles detailed audit trails, including user ID, timestamps, and chain of custody details.

Instem ensures cost-effective deployment with simplified integration into existing systems, avoiding extensive IT overhauls. Built-in validation templates help ensure immediate compliance benefits, while automation replaces error-prone manual record-keeping to improve operational efficiency and accuracy.

How It Works

Compliance Builder enables comprehensive workflows to ensure data integrity, strengthen security, and provide transparency across your organization.

• Audit Trail: Captures every data event with secure, time-stamped records in standardized formats.
• Electronic Signatures: Enables compliant electronic signatures aligned with 21 CFR Part 11.
• Dashboards: Provides real-time visibility into compliance status and data events.
• Email Notifications & Alerts: Sends instant updates on critical changes or anomalies.
• Database Monitoring: Tracks structural and record-level changes across multiple databases.
• Revision History: Retrieves and compares full histories of file or database changes.
• Controlled User Access: Manages user access to ensure data security.
• Multi-Domain Support: Scales compliance monitoring seamlessly across enterprise environments.

Compliance Builder integrates with existing systems, working across various file systems, databases, Microsoft SharePoint®, lab and manufacturing equipment, and integrates with current security systems. It provides audit-ready documentation, electronic signatures, and full revision history while adhering to 21 CFR Part 11 requirements. The software operates independently of applications, ensuring monitoring and security features run without slowing down system performance. Instem offers implementation assistance, validation templates, user training, and ongoing support to ensure smooth adoption and long-term success.