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ComSoft 21 CFR Part 11 Software

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Product code: 0554-1705

Backorder Now, once ordered your item will dispatch before the 26th of May 2025, call 1300 737 871 (NZ 0800 737 871 to confirm).

The ComSoft 21 CFR Part 11 software means you get validatable software for programming and readout of Testo data loggers and for archiving data. It fulfils all the FDA's 21 CFR Part 11 requirements.

-Intuitive and validatable software for the pharmaceutical industry.

-Graphic and tabular display of all measurement parameters.

-Effortless creation and management of reports.

-Digital signature and audit trail for maximum security and safety.

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$3,013.00 AUD + GST
 $3,314.30 AUD Inc. GST
The ComSoft CFR 21 Part 11 software is validatable software and fulfils all the FDA's requirements in the framework of a closed system. Conformity with the CFR directives is confirmed by an independent institution.
Advantages and functions of the ComSoft 21 CFR Part 11 software
- Digital signature and audit trail for the traceability of user activities offer maximum security and safety
- Storage of raw data in tamper-proof file format
- Detection of transfer errors using checksums
- Inactivity lockout to prevent unauthorized access
- Intuitive and clearly-structured user interface. It guides users through individual work steps and enables effortless export of data, creation of reports and carrying out of analyses
- The software offers the opportunity to display and evaluate all recorded measurement parameters in both graphic and tabular format
- Measurement menus can be individually tailored and the data loggers can be brought together and organized into groups in clear tree structures according to the application site and intended use. That enables clear display of the whole transportation route
- Further advantages: Online measurement, creation of formulas, scientific-statistical evaluation (min./max./mean value, limit value violation)

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