QIAcuity® Digital PCR System And 21 CFR Part 11 Regulations

As more laboratories transition to electronic systems, compliance with 21 CFR Part 11 becomes essential for maintaining data integrity and meeting FDA expectations. The QIAcuity® Digital PCR System exemplifies a compliant closed system, combining secure user-based access, detailed audit trails, and electronic signature support.

Beyond its robust compliance framework, QIAcuity enables a wide range of digital PCR applications for cell and gene therapy development and quality control. These include viral vector genome titration, vector copy number (VCN) analysis, genome integrity testing, residual host cell DNA quantification, mycoplasma detection, replication-competent lentivirus (RCL) detection, and gene expression analysis. This versatility makes QIAcuity an indispensable platform for regulated biopharma and advanced therapy workflows.

Access the datasheet to see how the QIAcuity system supports compliance at every stage of electronic record handling.