CTL's products and solutions platform permits the entire ELISPOT process to take place within an environment ready to fulfill the requirements of 21 CFR Part 11. CTL has combined instrumentation and software with a powerful "Part 11 framework."
- Secure data storage
- Audit trails
- Record retention management
- Access control
- Data integrity
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 an ISO 9001:2008 Quality Management System.
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.
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.
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.
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.
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