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.
|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||✕||✕||✓|