ComSoft 21 CFR Part 11 - software

SKU: 0554 1705

Category: Accessories

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

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.

Delivery time: 6 - 7 Workdays (DE - int. shipments may differ)

1.695,27 €

incl. 19% VAT , plus

MSRP: 1.994,44 € incl. 19% VAT

(Save 15%, i.e. 299,17 €)

Product Description

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)