ComSoft 21 CFR Part 11 software

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)

Hlavní technická data	Systémové požadavky Windows® 10; Windows® 11 ; others on request
Normy CFR 21 část 11 (při použití se softwarem testo CFR)

Systémové požadavky

Windows® 10; Windows® 11 ; others on request

Normy

CFR 21 část 11 (při použití se softwarem testo CFR)