Versioning, Linking the analyzer and software, O_643 – BUCHI DuMaster D-480 User Manual

Page 74: O_644

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Operation Manual D-480

©BÜCH Labortechnik AG

Copyright Note

74

Restricted access to menu functions

The software restricts access to the menu functions on the basis of three user groups:

The lowest user group may only perform actions required in routine operation.

The middle user group may also perform actions requiring experience, e.g. calibration.

The top user group may also perform actions requiring a great deal of experience, e. g. changes
to the system configuration.

The software also prevents unauthorized individuals from interfering with the system when the
authorized user is not present. If the user has not performed an action for some time, the software
prompts him to log in again.

Versioning

Versioning

If 21 CFR Part 11 functionality is enabled, a new version of the document is created as soon as an
analyzed sample is changed.

Version identification

Every version is identified as follows:

with an index number,

with the date of creation,

and with the name of the user who made the change.

The current version is number 0, the previous versions are indexed -1, -2, etc.

Protection of previous versions

Previous versions are write-protected, i.e. they cannot be edited but only viewed or printed out.

Linking the analyzer and software

Background

It is important that the analysis data can be unambiguously allocated to the analyzer with which they
were generated. This allocation is performed via a serial number. In every instrument, the individual
serial number is stored in a memory module and queried by the software when you launch the
program. The program can only be operated in combination with the analyzer if the serial number
matches the software licence number. This ensures that the analyzer is always operated together
with the same software and the settings recorded in the logbook.

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