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)
testo ComSoft 21 CFR Part 11 Software (as download with registration) for PC installation, including instruction manual.