Answer

How does the ImmunoSpot system comply with 21 CFR Part 11?

The ImmunoSpot® system supports Part 11 compliance by providing encoder-controlled high-precision stages and well verification, combined with device checks during data acquisition. The software prohibits overwriting of scanned images, spot counting results and quality-controlled files, and always maintains time-stamped backups of existing data. It also safeguards the data by recording both the operator ID and the encoder positions for each well.

In addition, ImmunoSpot® ensures data integrity by providing the ability to detect altered ELISPOT data records. All systems are set up with access limitations and are fully administrable using the Windows file privilege system.

For validation and calibration purposes, CTL provides consultation services and technical documentation to facilitate the customer's assessment process. CTL also provides its customers with individually tailored solutions so as to support efficient workflow of ELISPOT assays and general laboratory work.

For further information, please do not hesitate to get in touch with us.

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