Security access

According to 21 CFR Part 11 regulation C-BIO has four hierarchical levels of access, each with its own password.
The levels are: Viewer (without password), Operator, Engineer, and Administrator.
Each level has different access for different features of SCADA:

VIEWER:

• Observe main screen

OPERATOR:

• Operate controllers
• Calibrate the Dissolved Oxygen and pH controllers
• Start/stop sequences
• Modify sequence descriptions
• View sequence contents and status
• Modify sequence logging list
• View alarms and events
• Change log rate
• Start/stop batches
• Start/stop profiles
• View the log file list
• View the digital output list
• Configure/operate the pulsed digitals
• Operate the graphics
• Perform emergency stop

ENGINEER :

In addition to the Operator functions, the engineer may:

• Change controller configurations
• Perform calibrations
• Edit sequences
• Create and modify profiles
• Edit the alarm messages list
• Archive and recover system databases
• Edit the system configuration
• Edit the system maintenance function
• Edit the calculations page

ADMINISTRATOR :

In addition to the Engineer functions, the Administrator may:

• Edit and change passwords

Menu for user login into the systemThe system can perform an auto-logoff of the current user after a configurable time of user inactivity has elapsed.

The creation or modification of new users are restricted to the Windows Administrator account or Administrators group.

All users have a unique user name and password

A user is defined by the following parameters :

• User ID: Identity of the user (15 characters maximum)
• User Name: Name of the user (15 characters maximum)
• Password: Password of the user (15 characters maximum)
• Active: status of the user account. When the user is not present in the company, this option allows to deactivate this account. An account is not deletable.
• Acces level: User’s acces level.
• Password validity: time of user password validity. At the end of X days the user will be asked to reset his password. The last 10 passwords of each user are recorded in the database and are not reusable.
• Inhibition: User account inhibition, if the user tries to connect to the system X times in vain, his/her account will be inhibited and only administrator will be able to activate it.
• Time before LOGOUT: Time of inactivity before logout, if the user is logged in and he does not perform any action during X seconds, the user will be logged out automaticaly.
• Verifier: Electronic sign. If this option is ticked, it allows the user to sign electronically his/her every filed action.
• Trial number: Number of connection attempts allowed.