Cell Microsystems adds Part 11 compliance software to CellRaft AIR

Cell Microsystems launched new software for its CellRaft AIR System on July 15, 2026, adding workflow controls designed to support 21 CFR Part 11 compliance. The update broadens the platform from discovery and cell line development into regulated cell-based workflows for biopharma, cell therapy and gene editing programs.

Why it matters: - Cell line development teams face tighter requirements for data integrity, traceability and documentation as programs move toward clinical and commercial stages. - The new software gives CellRaft AIR users compliance-focused controls intended to support regulated workflows without changing the platform’s core single-cell isolation approach. - The update could help labs bridge early discovery work and regulated therapeutic development on the same system.

What happened: - Cell Microsystems announced new software for the CellRaft AIR System on July 15, 2026. - The software is designed to support 21 CFR Part 11 compliance. - The launch expands CellRaft AIR from a discovery and cell line development platform into one that can support regulated cell-based workflows. - The company also said the software is designed specifically for CellRaft AIR workflows.

The details: - The software is built to support secure electronic records, audit trails, user accountability and process transparency throughout cell line development. - The platform supports traceability from single-cell identification to clone selection. - The software is positioned to help laboratories generate documentation for quality and regulatory review. - The workflow controls are described as validation-ready for regulated laboratories. - Key features include secure user authentication and role-based access controls. - The software includes electronic signatures for workflow approvals and audit readiness. - Automated audit trails provide time-stamped event logging. - Protected electronic records use controlled data access. - The software improves traceability of clone selection and monoclonality documentation. - Data retention and reporting tools support quality and regulatory review. - CellRaft AIR images, tracks and isolates single cells and monoclonal colonies through a gentle, fluidics-free workflow. - The technology keeps cells in a shared-media culture environment during colony formation. - Cell Microsystems says that approach reduces cellular stress and improves the success rate of monoclonal cell line development. - The company says the platform combines automated imaging, AI-assisted isolation verification and secure workflow controls in a single system. - The release says the expanded platform is intended to support monoclonal production cell lines, gene-edited therapeutic cell lines, cell therapy and CAR-T workflows, iPSC-derived cellular products, and rare or difficult-to-clone cell populations. - Cell Microsystems’ product line also includes BioFlux Shear Flow Systems, the CERO 3D Cell Culture & Bioreactor and lab services. - More information is available at the company’s CellRaft AIR page. - The company’s LinkedIn page is available at Cell Microsystems on LinkedIn.

Between the lines: - The launch is aimed at moving CellRaft AIR deeper into regulated manufacturing and therapeutic-development settings. - The emphasis on audit trails, signatures and controlled records signals a push to make the platform usable beyond research-only environments. - Cell Microsystems is trying to preserve the biological advantages of its isolation workflow while adding the documentation layer regulators and quality teams expect. - President Scott McGinnis said the software lets customers combine CellRaft AIR’s biological advantages with compliance infrastructure needed for therapeutic development and manufacturing workflows.

What's next: - Cell Microsystems is positioning CellRaft AIR for broader adoption in regulated cell-based programs. - The company is targeting teams developing monoclonal, gene-edited and therapy-focused cell products. - Future use will likely depend on how well the software fits validation, documentation and manufacturing requirements inside regulated labs.

The bottom line: - Cell Microsystems is turning CellRaft AIR from a discovery tool into a regulated-workflow platform by layering Part 11-oriented software on top of its single-cell isolation system.