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1+ | £1,643.000 |
Product Information
Product Overview
0554 1705 is a ComSoft CFR 21 Part 11 software for requirements according to CFR 21 Part 11 for the programming and readout of Testo data logger. It includes all the functions of ComSoft Professional. This ComSoft CFR 21 Part 11 is a validatable software and fulfils all requirements of the FDA (Food and Drug Administration) in a closed system. Conformity with the CFR guidelines is confirmed by an independent institute. It supports Testo data loggers from the instrument series testo 174, testo 175, testo 176 and testo 184 and can be run on Windows® 10; Windows® 11; Further operating systems on request.
- Administration of user groups by administrator
- Storage of raw data in tamper-proof file format
- Recognition of carry-over errors thanks to test sums
- Inactivity lockout to prevent unauthorized access
- Monitoring of login/logout activity, successful/unsuccessful use of digital signatures
- Alteration of raw data with the help of an Audit Trail
- Software for pharmaceutical requirements
Technical Specifications
Validatable Software
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English
Testo 174, 175, 176 and 184 Series Data Loggers
No SVHC (23-Jan-2024)
CFR 21 Part 11
Download
Windows 10, 11
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Technical Docs (1)
Legislation and Environmental
Country in which last significant manufacturing process was carried outCountry of Origin:Germany
Country in which last significant manufacturing process was carried out
RoHS
Product Compliance Certificate