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Title 21 CFR Part 11

Arrigo Local fulfills the requirements of Title 21 CFR Part 11 from v1.4.75 and later.

The following security additions were added to Arrigo Local in order to support Title 21 CFR Part 11:

  • A user state that can be used by a system administrator to force a user to change password, or to block a user from logging in altogether.
  • An option to not allow the system administrator to delete users.
  • Possibility to require the user to enter his/her password for each maneuver in Widgets and Views in Arrigo Local (electronic signatures).
  • Possibility to allow or require the user to write comments for maneuvers in Arrigo Local.
  • Possibility to set user passwords to expire after a configurable number of days.
  • Possibility to block a user or the system after a maximum number of failed login attempts, and automatically sent e-mails to the user and the system administrator when the maximum number is reached.
  • Possibility to configure user password requirements.

Arrigo Local configuration

Maneuver Panel

The visibility/usage of the new Maneuver Panel is controlled using the Arrigo theme file. In order to activate the Maneuver Panel you must complete these steps:

  • Navigate to %ProgramFiles%\Arrigo\Arrigo Local\Frontend
  • Create the folder theme, if it doesn't already exist.
  • Inside the theme folder, create a new file called theme.json. Make sure that the extension (.json) is correct, as Windows sometimes hides the extension and a file called theme.json.txt is created.
  • Open the file theme.json in an editor with administrative privileges
  • If the file is new/empty, simply paste the following snippet and save the file: 
{
  "ManeuverPanel": "Yes"
}
  • If the file already contain entries, paste the following snippet at the end of the file (before the last curly bracket }): 
  , "ManeuverPanel": "Yes"

Use an online JSON validator to verify that there are no errors in the file. JSONLint is a good, free validator (simply paste the entire content of the theme.json file and validate).

  • Save the file and perform an IIS Reset (Press start, type run, press Enter, type IISreset and press Enter again)

Info

Only Maneuver style DialogBox works with the new maneuver panel. No ClickOnly Elements. Both widgets and Animation view elements works in DialogBox Maneuver style.

Password expiration notice

You can control the password expiration notice through the theme file.
Once activate, users will be notified when they have 10 or fewer days left before their password expires.

  • Navigate to %ProgramFiles%\Arrigo\Arrigo Local\Frontend
  • Create the folder theme, if it doesn't already exist.
  • Inside the theme folder, create a new file called theme.json. Make sure that the extension (.json) is correct, as Windows sometimes hides the extension and a file called theme.json.txt is created.
  • Open the file theme.json in an editor with administrative privileges
  • If the file is new/empty, simply paste the following snippet and save the file: 
{
  "passwordExpirationCheck": "Yes"
}
  • If the file already contain entries, paste the following snippet at the end of the file (before the last curly bracket }): 
  , "passwordExpirationCheck": "Yes"

Use an online JSON validator to verify that there are no errors in the file. JSONLint is a good, free validator (simply paste the entire content of the theme.json file and validate).

  • Save the file and perform an IIS Reset (Press start, type run, press Enter, type IISreset and press Enter again)

Note

Note that you have to activate the password expiration notice to be able to change password without using the "Request new password via email" functionality.
If the notice is activated, users can change passwords directly in the UI.

Auto logout

You can control the auto logout feature through the theme file.
Once activate, users will be automatically logged out after a set minutes of inactivity.
This time is set/configured using the regular Arrigo User Administration interface.

  • Navigate to %ProgramFiles%\Arrigo\Arrigo Local\Frontend
  • Create the folder theme, if it doesn't already exist.
  • Inside the theme folder, create a new file called theme.json. Make sure that the extension (.json) is correct, as Windows sometimes hides the extension and a file called theme.json.txt is created.
  • Open the file theme.json in an editor with administrative privileges
  • If the file is new/empty, simply paste the following snippet and save the file: 
{
  "enableAutoLogout": "Yes"
}
  • If the file already contain entries, paste the following snippet at the end of the file (before the last curly bracket }): 
  , "enableAutoLogout": "Yes"

Use an online JSON validator to verify that there are no errors in the file. JSONLint is a good, free validator (simply paste the entire content of the theme.json file and validate).

  • Save the file and perform an IIS Reset (Press start, type run, press Enter, type IISreset and press Enter again)

Electronic signature & Maneuver Comment

These features are controlled using the file Comp:\EXOscadaWebSettings.ExoXml.
The same settings as for EXOscada are applicable in Arrigo.

Request password

In order for this function to work, you must first configure the EXOscada Email Add-in. Instructions on this can be found in the EXOscada help system.
Also make sure that all users have a configured email address (in the User Administration) and that no duplicate email addresses exist.

Patch EXO installation

In order to get the "Request new password via email" functionality to work, you must complete these steps:

  • Download the file EXOscadaWeb.zip
  • Extract all files
  • Copy the files to %ReginInstallationFolder%\Texts, overwriting any existing files

If you omit these steps, a "Request new password" email will still be sent but it will contain a non-working link.

Warning

All localization files are stored in RAM-memory as well (if used). To reload the files, a complete restart of all loaded dlls is required. (Use "Stop all EXO progams" to unload the dll.). Restart EXOscada/EXO.