Analyzer Compliance

Regulatory compliance of ImmunoSpot® Readers.

About 1,000 of our ImmunoSpot® Readers operate in a regulated environment, having satisfied in house and third-party audits, including audits of regulatory agencies.

We offer IQ, OQ and PQ 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