Image
    1. Home
    2. ComSoft 21 CFR Part 11

    ComSoft 21 CFR Part 11 v4.6 - software

    Product no. 0554 1705
    testo ComSoft 21 CFR Part 11 software
    ZAR 39,637.40with VAT ZAR 45,583.01
    +27 87 7112277
    Submit a request
    Your advantages
  1. Intuitive and validatable software for the pharmaceutical industry
  2. Graphic and tabular display of all measurement parameters
  3. Effortless creation and management of reports
  4. Digital signature and audit trail for maximum security and safety
    5. 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.

    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)

    Delivery Scope

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

    Related Products

  5. testo 176 H1
    testo 175 H1 - Temperature and humidity data logger
      Product no.:
      0572 1754
      ZAR 7,638.95with VAT ZAR 8,784.79
      1
    • testo 175 T1
      testo 175 T1 - Temperature data logger
        Product no.:
        0572 1751
        ZAR 3,807.65with VAT ZAR 4,378.80
        1
      • testo 175 T2
        testo 175 T2 - Temperature data logger
          Product no.:
          0572 1752
          ZAR 4,730.00with VAT ZAR 5,439.50

          • Technical data

          General technical data

          System requirements
          Windows® 10; Windows® 11 ; others on request
          Standards
          CFR 21 Part 11 (in use with testo ComSoft CFR-Software)

          Downloads

          Product brochures

          Software

          x

          Delivery within South Africa

          For purchases via our Online shop

          Didn’t find what you were looking for? Tell us your measurement job, we’re happy to help!

          Hello Testo team, I have the following query:

          Please note our Data Privacy Statement.

          Submit query now

          Mail Contact
          PhoneCall +27 87 7112277 +27 87 7112277