The US Food and Drug Administration (FDA) has defined mandatory regulations to ensure final product quality through proper design, analysis, and control of manufacturing operations. Specifically, 21 CFR Part 11 regulation is a comprehensive legislation that describes the required controls for utilizing electronic records and electronic signatures. TrakSYS supports compliance with 21 CFR Part 11 through management of electronic records, audit trails (defined by workflow and procedures), and electronic signatures.
TrakSYS actively monitors and records changes to the existing infrastructure configuration, setpoints, products, tasks, maintenance activities, and recorded values. Any can trigger notifications for the needed authorization via multi-layer electronic signatures. Since Comprehensive electronic records are kept, TrakSYS readily produces in-depth reports for detailed analysis and regulatory compliance
Features and benefits
- No changes to current infrastructure required
- Comprehensive electronic data record keeping
- Thorough task and notification management
- Electronic signature validation
- Comprehensive reports and analysis
- Compliance with FDA 21 CFR Part 11 document management standards
- Improved final product quality