Mesa Labs DataTrace® Pro Software is the core application for the DataTrace® MPRF and MPIII wireless data logging systems, providing a comprehensive solution for critical process monitoring and validation in highly regulated industries like pharmaceutical, healthcare, medical device manufacturing, and food processing. The software is specifically designed to meet stringent regulatory requirements, including FDA 21 CFR Part 11 and GxP compliance, with available validation packages (IQ/OQ/PQ documents) and a Validation Manual.
Key Capabilities
- Regulatory Compliance: Integrates smart security and regulatory features essential for audit trails, data integrity, and electronic record-keeping.
- Data Analysis & Reporting: Enables the creation of custom report templates, simplified report generation in PDF format, detailed data analysis, and user-defined pass/fail conditions. It can perform complex calculations like lethality (F0, PU) for food processing and sterilization.
- Calibration Management: Features in-software pre- and post-calibration verification and utility interfaces with metrology equipment for automated calibration checking and adjustment.
- Alarm & Notification System: Users can set numerous alarms and receive email notifications for deviations, fault detection, and calibration-due warnings.
- Scalability: Available in tiered licenses (Basic, Plus, LAN Server) to support single-user desktop applications up to large-scale network deployments with shared databases across multiple installations.
Target Users and Use Cases
DataTrace Pro is essential for Quality Assurance (QA), Validation, and Manufacturing teams responsible for ensuring product safety and process efficacy. Primary use cases include process validation and monitoring during:
- Sterilization: Steam, Ethylene Oxide (EO), and other modalities.
- Thermal Processing: Pasteurization, Retort, Canning, and Lyophilization (Freeze-Drying).
- Environmental Monitoring: Temperature, pressure, and humidity monitoring in critical storage and manufacturing environments.
