Compliance Builder:
One Platform for
Total Compliance
Compliance Builder is dedicated software for real-time compliance monitoring. This purpose-built solution enables organizations to seamlessly manage electronic document and signature control compliance across all IT systems. Compliance Builder ensures 21 CFR Part 11 compliance, maintaining data integrity and security across files, databases, and applications for accuracy, traceability, and audit readiness.
What is Compliance Builder?
Compliance Builder is a real-time monitoring software that enables organizations to track data and changes across all major file types, including Microsoft documents, graphics, recipes, lab instrumentation files, and SAS datasets, on any file-based system. With this comprehensive software, teams can examine file lifecycles in detail, ensuring compliance and data security at any scale.
Data security requirements are becoming more stringent, leaving large, established companies vulnerable to outdated systems, fragmented processes, and increased regulatory scrutiny. Managing large, diverse datasets with multi-user access and frequent changes makes tracking even more challenging and can cause companies to fall short of FDA 21 CFR Part 11 standards.
Compliance Builder is system-agnostic and enables teams to integrate advanced compliance tools with legacy data systems, safeguarding archives and extending the lifespan of existing infrastructure. Compliance Builder enables teams to generate a robust chain of custody, creating complete audit-ready records that enhance compliance and data integrity.
Key Benefits of Compliance Builder
Improved Compliance
A comprehensive monitoring system ensures 21 CFR Part 11 compliance and tracks data changes, downloads, and electronic signatures across diverse sources, including legacy databases, while providing complete chain of custody documentation.
Enhanced Flexibility
This software supports the most widely used file types and can be deployed within existing systems for simplified adaptability and long-term scalability.
Robust Security
Compliance Builder protects sensitive data with layered access controls, real-time alerts, email notifications, and database monitoring to minimize risk and ensure data integrity.
Greater Efficiency
Compliance Builder arrives with validation documentation templates enabling rapid deployment, while computer-generated audit trails reduce the need for inefficient, error-prone manual work.
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
Ensure 21 CFR Part 11 compliance by recording and securing all data events with audit trails and electronic signatures while reducing paper records and maintaining data integrity, transparency, and regulatory adherence.
Application Security
Compliance Builder integrates with existing security systems to control user access and protect raw data, with layered controls, sign-off authorization, audit trails, and file revision comparison capabilities.
Configurable Electronic Signatures
Utilize three configurable electronic signature levels: Silent, Acknowledgement, and Signature Confirmation, to align signature requirements with internal policies.
Database Monitoring & Audit Trail
Monitor structural and record changes across multiple databases with full audit trails and utilize a dedicated Microsoft SharePoint® module to detect unusual download activity and send alerts to prevent fraud and data leaks.
Configurable Security Options
Utilize flexible security options, including electronic signatures, user sign-offs, and folder-level email alerts without impacting application performance.
Why Choose Compliance Builder?
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. Compliance Builder is system-agnostic and works with nearly any file type or database, including Oracle, SQL Server, and Microsoft Access. It compiles highly detailed audit trails, which include user ID, timestamps, and chain of custody details.
Instem ensures cost-effective deployment of Compliance Builder with simplified integration into existing systems, meaning companies avoid the costs of 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
Capture every data event with secure, time-stamped records in standardized formats.
Electronic Signatures
Enable compliant electronic signatures aligned with 21 CFR Part 11.
Dashboards
Gain real-time visibility into compliance status and data events.
Email Notifications & Alerts
Receive instant updates on critical changes or anomalies.
Database Monitoring
Track structural and record-level changes across multiple databases.
Revision History
Retrieve and compare full histories of file or database changes.
Controlled User Access
Receive instant updates on critical changes or anomalies.
Multi-Domain Support
Scale compliance monitoring seamlessly across enterprise environments.
Frequently Asked Questions
Does Compliance Builder integrate with existing systems?
Yes. It works across various file systems, databases, Microsoft SharePoint®, lab and manufacturing equipment, and integrates with current security systems.
How does Compliance Builder support compliance?
It provides audit-ready documentation, electronic signatures, and full revision history while adhering to 21 CFR Part 11 requirements.
Will implementation impact performance?
No. Compliance Builder operates independently of applications, ensuring monitoring and security features run without slowing down system performance.
What support and training are provided?
Instem offers implementation assistance, validation templates, user training, and ongoing support to ensure smooth adoption and long-term success.
Get a Free Demo Today
Compliance Builder ensures seamless 21 CFR Part 11 compliance across all files, datasets, and instruments. With simplified integration and validation, it provides a single, cost-effective solution to safeguard data integrity and maintain regulatory compliance—delivering immediate efficiency gains and long-term value. Strengthen your compliance strategy with Compliance Builder.