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Compliance Builder

Compliance Builder enables FDA 21 CFR Part 11 compliance by monitoring files, databases, and digital devices in GxP labs. It generates audit trails, supports electronic signatures, and prevents unauthorized data changes, ensuring data integrity for pharmaceutical, life sciences, and medical device companies.

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Software Info

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Compliance Builder Overview

Compliance Builder is a real-time auditing and security solution designed specifically for GxP laboratory environments, helping organizations meet FDA 21 CFR Part 11 compliance. Trusted by leading pharmaceutical, life sciences, and medical device companies, it monitors data files, databases, and digital devices to ensure data integrity and prevent unauthorized manipulation. The platform generates fully attributable audit trails, manages file revisions, and supports electronic signatures. It offers platform-agnostic monitoring, deletion protection, and workstation safeguards, enabling seamless compliance across file systems, databases, and lab or manufacturing instruments for robust regulatory adherence.

Features

Real-Time File and Database Monitoring

Comprehensive Audit Trail and Electronic Signatures

Version Control and Document Management

Customizable Reporting and Alerts

Compliance Builder Pricing Overview

Compliance Builder Score

Smyte Score

5 Number of Reviews 1

Smyte Score

The Smyte Score is a weighted average from leading review sites across the web.

100+ reviews for Software Name

Pros

Robust Compliance Monitoring:
Users praise Compliance Builder for its comprehensive real-time monitoring capabilities that ensure adherence to FDA 21 CFR Part 11 requirements.

Detailed Audit Trails:
The software reliably creates fully attributable audit trails and tracks all file changes, supporting regulatory audits.

Flexible & Platform-Agnostic:
It works across multiple IT systems and devices (file systems, databases, lab instruments), making it adaptable to various organizational setups.

Cons

Complex Setup & Configuration:
Some users mention that initial installation and configuration can be complicated, requiring dedicated IT resources.

User Interface:
A few users find the UI outdated or less intuitive compared to more modern software solutions.

Limited Customer Support:
Some reviews note slower response times and limited support availability during critical issues.

** Smyte uses AI to analyze online reviews, extracting key pros and cons by identifying patterns and summarizing customer feedback into actionable insights.