User Interface Window
Information to Text File
Saves the text in the Code Search Result and Processing Information Window
to a Rich Text Format File (*.rtf)
SPL File (XML)
Renders the selected SPL file to a comprehensive and searchable Tree View.
Exits the Application
Arrange and/or tile multiple windows on the screen for better editing
SPL Data Edit
Window - Single Information Item:
Double Click or select and press enter on the item to be edited.
Data Edit Window - Multiple Information Item:
Double Click or select and press
enter on the parent item of the items to be edited.
R4 Processing Information Window
SPL Document Menu
Creates a New and empty template for SPL R4 Document
authoring: Establishment Registration, Drug Listing, NDC Labeler Code Request
Open an existing SPL R4 document.
Hint: You can create SPL R4 document templates for your different submissions.
Save Settings As...
Save the authored SPL R4 Settings Document to file.
Creates a HTML Report containing all data of the SPL
R4 File - The Report can be used for company internal documentation purposes.
Note: This functionality creates the folder "SPLReportImages" in the
same folder where the report file is saved. If you move the report file to
another location, the "SPLReportImages" folder
needs to be copied as well.
Search and/or replace text in the SPL R4 Document.
Note: you can search also for empty values
Product Label from Word...
With this menu the Product Label in Microsoft Word Document Format can be
imported to SPL Document being authored. Please see Product Label
user manual section for details.
LOINC Codes to Product Label
With this functionality, required LOINC codes can be added retroactively to
the SPL document being authored once the Label has been imported from Word Document.
Creates the SPL file for FDA submission from the
SPL R4 Document authored.
Connects to the FDA/Pragmatic Data
online Validator under:
online Validator discovers
95% of the errors in an SPL document.
Its strongly recommended that an SPL Document is checked with the online
Validator before being submitted to FDA
Search Code System
by Code or Name
With this utility the SPLCodeSystems.mdb database can be searched for available codes by
name or the code itself - Code systems provided are: LOINC, NCI Thesaurus and
Enter the text to be searched, select the desired code system then press enter or click
All codes and names found are displayed in the Log window.
To clear the Info Window content, click the "Clear" button.
If you want to copy Text from the SPL Info Window you can use MS Windows Command
CTRL+C, or right click.
Whenever an Item in the document tree has to be coded with a code system, the
data entry form will display the search button "[?]" enter, the name
or code then click the button. Corresponding codes will be listed.
Editing SPL R4 Document Information and Building SPL file for submission
The SPL R4 Document Information is displayed as a tree view, you can
navigate via mouse or keyboard trough the tree items and edit the desired data.
edit an information item, double click it or press enter on your keyboard.
Depending on the SPL R4 information to be entered, the application renders Code
Search Functionalities, Drop Down lists etc.
can be dragged and dropped between tree items even on different SPL R4 Document
Windows (left mouse button) and from the code system search results (right
you are done with the SPL R4 document authoring, the SPL file for FDA submission
can be generated with the menu function "SPL R4 Document" >
right mouse button provides additional editing and import functionalities on
tree items - the menu entry displayed depends on the selected tree item.
Shows the Data Edit Window depending on the selected
Allows to set the back color of the selected item.
This function is useful to mark items for later editing.
Opens the file or folder of the selected item (e.g.
IDs and GUIDs
Creates the ID/ GUIDs needed in SPL Document Sections of all sub-items of
the selected tree item.
Data from Existing SPL File...
Imports data to selected tree item
from an existing SPL file - e.g. from SPL files available on Daily Med
Create a copy of the selected information item
Add more Information to the selected Information
Copy Information Item Name and Text to Clipboard
All/ Collapse All
Expand/ collapse SPL R4 Document Tree
Remove Selected Information Item
about the data requested by FDA for SPL R4 submissions and on authoring SPL R4
Documents can be found under:
SPL R4 Online Resources
An online validation tool for SPL R4 Documents is provided under: