LogTag Software Analyzer - Digital Signature (FDA 21CFR11)

Software package "Digital signatures"

This package allows users with the appropriate access authorization to provide a LogTag data recording with different, previously assigned digital signatures.
These digital signatures are saved together with the data recording in the LogTag file and provide the following information:

• The full name of the signatory
• The date and time at which the signature was executed
• The meaning associated with this signature (e.g. file creation, verification, acceptance or responsibility)

Digital signatures are permanently stored with the LogTag file.
Users with corresponding access authorization can be clearly assigned via user name and password.

LogTag uses a "client-server" architecture to manage access authorization.

In addition to the standard software "LogTag Analyzer", two other programs are used: "LogTag User Server" and "LogTag Event Viewer"

LogTag Analyzer

This is the standard software for configuring and reading out LogTag data loggers. It runs on those PCs that read out and analyze LogTags and save the data.

LogTag User Server

LogTag User Server is normally installed on a network server, but can also run on the same PC as Analyzer, provided that the safety requirements of FDA 21 CFR 11 are met.
The User Server software controls access to the user and signature database for all correctly configured LogTag Analyzer clients and records the activities of individual users in the "audit log".

LogTag Event Viewer

The LogTag Event Viewer allows you to view the audit log. This software is normally installed on the same PC as LogTag User Server, but can also run on other PCs, provided they have access to the directory in which the event log files are stored.