Regulatory compliance of ImmunoSpot® Readers

The hardware and software of ImmunoSpot® Readers has been designed to meet regulatory compliance standards.

We offer IQ and OQ for our regulated customers. Our ImmunoCompliance™ Package includes a three-tier offering.

Feature Basic Extended Advanced
ImmunoSpot® Professional Software for ELISPOT data evaluation and correction
Instrument Qualification Reference Plate
ImmunoQualify™ - Software tool for periodic instrument performance qualification
Application-level user authentication
Integrated barcode reader for automated, high throughput plate labeling during acquisition
ELISPOT data security features for identifying raw data modifications
RAID recovery system for data backup/recovery
Data Access Protection Service
Extended Log Service
CTL ImmunoData™ Storage - Integration Package

Learn more about the regulatory compliance of CTL’s software.