ImmunoCompliance™ ELISPOT
CTL, as the leader in ELISPOT technology, has carefully elevated its products and solutions onto a platform that permits the entire ELISPOT process taking place within an environment ready to fulfill the requirements from Part 11. CTL has combined instrumentation and software with a powerful "Part 11 framework." Features include:
Secure data storage
Audit trails
Record retention management
Access control
Data integrity
To facilitate GLP regulated workflow, CTL offers ImmunoCompliance. The ImmunoCompliance™ package consists of CTL’s ImmunoQuality™ package and CTL’s ImmunoData™ Storage Software and includes the following components.
ImmunoSpot® Analyzer
CTL’s ImmunoSpot® Analyzers have integrated a variety of features to meet regulatory requirements including an encoder controlled device check of the data source verifying well positions during acquisition, a barcode reader permitting the verification of the plate alignment, and a RAID system supporting data recovery.
ImmunoSpot® ImmunoCapture™
ImmunoSpot® ImmunoCapture is a login controlled application that stores data directly into the ImmunoData Storage Software where all files are assigned an object type with attributes for further record control such as retrieval and subsequent processing. The application also creates a log file recording data entries made during automated routine operation.
ImmunoData™ Storage Software
The ImmunoData™ Storage System integrates the ImmunoSpot® platform with 21CFR Part11 compliant data controls for file based audit-trails, data security, check-in, check-out and lifecycle management of records. Not only does this allow the user to scan, count and review ELISPOT assays under the control of a powerful record management system, also is this system seamlessly integrated in Windows® and can accommodate any other document or data file.
ImmunoSpot® Counting
Counting results are kept separate from the raw data in order not to obscure the previous data. All data delivered in Excel®, text, or other formats is monitored for possible changes. Audit trails are automatically generated for each data file.
ImmunoSpot® Quality Control
In the quality control step, the user makes the ultimate judgment of the quality of the results. The software permits the capture of annotations for each well indicating what and why changes were made.
ImmunoQualify™ Software
ImmunoQualify™ is a software tool that permits the qualification of the reader’s status on a regular and repeating basis. It automatically compares CTL’s artificial reference plate with the actual reference value that is unique for each device.
ImmunoQuality™ Package
CTL’s ImmunoQuality™ Package can also be purchased separately. ImmunoQuality™ is a hardware and software package with GLP compliant features including the ImmunoQualify™ software, ImmunoSpot® Professional Software, Instrument qualification reference plate, integrated barcode reader, user authentication, ELISPOT data security, and RAID system for data backup and recovery.