21CFR11 Manager
21CFR11 Manager
Compliance. Control.
The 21CFR11 Manager Extension empowers GBG Scheduler with tools to meet FDA 21 CFR Part 11 requirements—without burdening your team or slowing down your science. It ensures your automated workflows are compliant with electronic records and electronic signature (ERES) regulations, providing traceability and security where it matters most.
- Built for regulated environments
- Maintain compliance without sacrificing flexibility
Why labs choose 21CFR11 Manager
Built-in compliance
Native 21 CFR Part 11 support, fully integrated into the GBG Scheduler experience
Designed for audit readiness
Track, trace, and validate actions taken across your automation environment
Features of 21CFR11 Manager
Electronic signature support
Electronic signature support
Approve and verify key actions and changes with layered user authentication
Complete audit trails
Complete audit trails
Automatically generate and store detailed, timestamped records of all user and system activity
Robust user access control
Robust user access control
Assign roles and permissions at a granular level to ensure only authorized users can act
Tamper-proof logging
Tamper-proof logging
Safeguard critical data with logging that ensure traceability for compliance inspections
The 21CFR11 Manager Extension integrates seamlessly with GBG Scheduler. It brings built-in compliance capabilities to every part of your lab’s scheduling and execution workflow. Whether you're deploying a single cell assay or a multi-day screening protocol, you’ll meet compliance standards—without creating friction.
Additional resources
Support for your automation solution
Biosero ensures that you have visibility and control at your fingertips to maximize your investment.
- Training at your own pace
- Virtual troubleshooting
- 24/7 access to Biosero Portal
- Driver swaps
- Easy to upgrade and patch