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:
Observe main screen
Calibrate the Dissolved Oxygen and pH controllers
Modify sequence descriptions
View sequence contents and status
Modify sequence logging list
View alarms and events
Change log rate
View the log file list
View the digital output list
Configure, operate the pulsed digitals
Operate the graphics
Perform emergency stop, digitals safe
In addition to the Operator functions, the engineer may:
Change controller configurations
Create and profiles
Edit the alarm messages list
Archive and recover system databases
Edit the system configuration
Edit the system maintenance function
Edit the calculations page
In addition to the Engineer functions, the Administrator may:
Edit and change passwords
Menu for login user to system
The 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 define 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 a user isn’t present in the company, this option allows to deactivate an user account. An account isn’t deletable.
Acces level : User’s acces level
Password validity : time of password’s validity for each user. At the end of x days the user will be invited to reset his password. The last 10 passwords of each user are recording in database and are not reusable.
Inhibition : User account inhibition, if an user try to connect itself x time in vain, his account will be inhibited and only an administrator will desinhibited it.
Time before LOGOUT : Time of inactivity before logout, if an user is logged and he doesn’t do any action during x secondes, the user will automaticaly logout.
Verifier : Electronic sign, if this option is ticked it’s allow the user to sign electronically each filed action.
Trial number : Number of connection attempts allowed.