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 | ✕ | ✕ | ✓ |