Compliance-ready features for regulated environments
Cell Microsystems has launched 21 CFR Part 11 software for its CellRaft® AIR System. Designed specifically for CellRaft AIR workflows, this licensed add-on extends the platform’s proven single-cell isolation capabilities into regulated development environments. As biopharmaceutical, cell therapy, and gene editing programs advance toward clinical and commercial milestones, development teams face rigorous demands for data integrity, traceability, and documentation. The software supports traceability from single-cell identification to clone selection, helping laboratories generate documentation for quality and regulatory review.
The CellRaft AIR System enables researchers to image, track, and isolate single cells and monoclonal colonies through a gentle, fluidics-free workflow, reducing cellular stress. The new software extends these capabilities with a validation-ready framework for managing electronic records and workflow approvals.
The software provides:
- Secure user authentication and role-based access control
- Electronic signatures for workflow approvals and audit readiness
- Automated audit trails with time-stamped event logging
- Protected electronic records with controlled data access
- Improved traceability of clone selection and monoclonality documentation
- Data retention and reporting tools for quality and regulatory review
For more information, visit the product page.