CTL Compliance

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 to take place within an environment ready to fulfill the requirements from 21 CFR 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™ Package-Basic, which includes the following components:

ImmunoQualify™ instrument calibration package, assuring proper functioning of the instrument, using a CTL reference plate. This is a functionality most people working in GLP environment need in order to calibrate their analyser on a regular base. How frequent this calibration should be is entirely dependent on the respective SOPs. The CTL reference plate has a validity of 12 months;

Application/password protection is a function which appears when the analyser is switched on, asking for a password to proceed working with the device. You can allocate different passwords for the different applications thus preventing a user from unauthorized work on a certain part of the software, e.g. you can restrict certain people only to their tasks, like only to capturing the images or capturing and analysing, or just analysing, doing the QC etc. The most common way of applying the application/ password protection is when a lab technician is responsible for capturing the images and analysing the plates, however, a more qualified person (scientist) will be entitled to do the QC;

User role-based access control permits you, beside the above-listed possibilities, to also check on the log book which user has executed which task;

Data security feature, which detects raw data manipulation. This function is also needed in the GLP environment for a reviewer to check if the raw data have been manipulated or tempered with after capturing. If data were tempered with, the following message will come up: Invalid signature;

RAID system for data backup and recovery as security measure against a hard drive crash. RAID system is a hardware component in your data processing unit. Your data are stored immediately and permanently on two hard disks, i.e. you have two identical mirrored images all the time;

Barcode reader. Researchers working with patient samples are obliged not to disclose the identity of the patients, therefore the plate is labelled with a barcode and the barcode reader in the system uses it to name the file. This makes the identification of the plates simpler and more efficient than the automatic numerical plate/file name generation allocated by the system when barcodes are absent.

ImmunoSpot® Analyzer

CTL ImmunoSpot® Analyzers have integrated a variety of features to meet regulatory requirements including an encoder controlled device check of the data source that verifies well positions during acquisition; a barcode reader permitting the verification of the plate alignment; and a RAID system supporting data recovery. And all ImmunoSpot® Analyzers are manufactured under ISO 9001:2008 standards.

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 21 CFR Part 11-compliant data controls for file-based audit trails, data security, check-in, check-out, and life cycle 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, this system also seamlessly integrates in Windows and can accommodate any other document or data file.

ImmunoSpot® Counting

Counting results are kept separate from the raw data in order to not 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 on the quality of the results. The software permits the capture of annotations for each well indicating what and why changes were made.

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CTL Compliance

ImmunoCompliance™ ELISPOT