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.
|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.