|
|
 |
 |
|
| |
What can I do to make CODESOFT Enterprise 6.x or above 21 CFR Part 11 Compliant? |
|
| |
In order to fit into an 21 CFR Part 11-compliant system, label design software must meet several criteria. Below are 3 ways a user can make CODESOFT Enterprise 6.x or above meet those criteria:
Step 1 - Secured Access for Label Design:
- Choose User Manager from the Tools menu or CODESOFT Program Group (in the Start menu). From the User Manager you can set up new groups or add new users.
Adding New Groups
- Choose New Profile from the User menu.
- Enter a name for that group.
- By default all new groups have Administrator rights. You will need to determine what rights you want your groups to have by checking/un-checking security rights.
Adding New Users
- Select the group you to which you wish to add a user and choose New User from the User menu.
- You will be able to select one of your already set user accounts from your network. Please note that in order to be bound by the rights set up in the preceding steps, users will have to log into the local machine as the user defined in the User Manager.
- Save your changes and close the User Manager.
Step 2 - Print Entered and or Retrieved Data Only:
- Right mouse click on an existing Form field and go to Variable properties…
- From the properties box make sure the Local Variable Value is empty and select the check box titled "Restore after printing".
- Repeat the above steps for all variables on your label.
Step 3 - Save Printed Data to a log file:
- Choose Printer Logfile from the Tools menu.
- Click on the radio button to turn on logging. Give the log file a name as well as location. Also select the default editor for the log file (Notepad and Microsoft Excel are examples).
- Click on the Options tab
Select from the list of logfile contents things you wish to include:
- Choose All Variables
- Choose the File Format type
- Define a Date Stamp if you choose.
|
|
|
|
