Quadra 4 Operator Manual
Tomtec
149
11.0 Tomtec FileSystem Watcher Service
(21CFR Option)
The Tomtec FileSystem Watcher Service is an optional software package that can be
added to monitor and log changes to files in specified folders.
11.1 FileSystem Watch Marketing Information
Overview
The Tomtec File System Monitor and Logging service is one component in a CFR11
compliant system. The other component is the Operating System that runs the software.
The Operating system is responsible for general security.
The Logging service is responsible for 3 operations, monitoring user program changes,
logging operations performed by the machine, and storing program options (on Quadra
Systems.
11.1.1 System Security
The users operating system (we require XP Professional for CFR11 compliance) is
responsible for general security. What this entails, is:
a. User login.
Each user that can operate the machine, in ANY fashion whether writing or running
programs, must have a unique login ID with a secure password.
Users cannot share ID’s or passwords, or the system IS NOT CFR11 compliant.
The logging service must be “secured” it is set up so that only people in the
Administrators group, can start/stop the service or change its configuration. It is up to
the administrators of the system, to determine who is in this group, they have the ability
to shut the system off or change its operation.
b. File System:
The directory that the logging service uses must be secured also, otherwise any user
that knows where the directory is, can just delete anything they want.
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