Note on Browser Comparability: The Pragmatic forms work with Mozilla Firefox (6 and higher), Internet Explorer (IE7 and higher), Google chrome (8 and higher) and Apple Safari (4 and higher). We recommend to use Mozilla Firefox and Google Chrome for better performance.

Note on performance for first time use: While using the forms for the very first time, the forms may take some time to load and certain operations can be slow. This is due to one time initialization cost for the forms.

Note on Submit to FDA Button: Submit to FDA is used for submission of SPL file through Pragmatic ESG Gateway. Before submission, we recommend to validate the file with the help of Validate button to resolve the errors and then try to submit the file. Please note that for document types No Change Notification(53410-7) and Out Of Business Notification(53411-5), Submit to FDA is not supported. We recommend to resend the past Establishment Registration instead of No Change Notification.

Tabs exist to split the form up and make it easier and faster to navigate.

1. The header tab is general document information.
2. The Data Elements tab is for product and indexing data elements.
3. The Content of Labeling tab is for the document text sections.
4. SPL View shows how the currently created SPL will look in the browser.
5. XML View is the full XML of the SPL and allows editing the XML directly.
6. Compare is for comparing 2 SPLs.
7. Help is this tab you are currently looking at.
8. Result tab will appear to show result of user actions such as validation or sending mail to FDA.

Collapse and expand form groups using the fat arrows shown on the top-left margin of collapsible groups. An arrow to the right (►) means a group is currently collapsed, click on it to expanded the group. An arrow downward (▼) means the group is currently expanded and can be collapsed by clicking on this arrow. Some key information about the group's content is displayed on the group title, as well as function buttons (see below). The group may expand on click of a function button depending on the operation corresponding to the function button.

To edit the files, you can type into any text field, drop down field (with direct type option) or auto-complete enabled text field, checkbox, etc.

There are 3 standard buttons which always have the same function "add" adds an item of the same kind, "delete" removes the present item, and "delete" clones the present item with all its data. Use the cloning mechanism if you intend to enter more complex structures repeatedly, such as for establishment organizations or parts of a product kit.

Copy & Paste functions are implemented for certain data elements. For example, addresses can be copied and pasted between different organizations or persons. Also, products (drug and devices) can be copied and then pasted to be parts of kits. If available, a button [%] means copy to clipboard and [&] means paste from clipboard.

To load an existing file, press the "Load File" button, select the file and press the "Load File" button in the file browser.

Adding data elements is possible by using the various other buttons which are presented by a single upper-case letter in square brackets (e.g. [A], [B], etc.) To understand the function of the buttons, please hover over them with the mouse to see the tool tip. The letters are chosen to be mnemonic and unambiguous, not always the initial of the data element name (e.g., "drug" and "device" both start with "D" hence we use the next distinguishing consonant "dRug" "deVice" to distinguish the two buttons.)

To add an image into content of labeling, take the following steps:

1. On the Section frame, click the "Image [+]" button.
2. Click on [Choose Image] button, select a JPEG image and press the "Choose Image" button in the file browser. Please select an image having a size less than 1 MB, otherwise it will throw an error message above the Tabs.
3. Finally add the image into the section text block using the "Insert/edit image" button that appears when the focus is on the Text block. You will be presented with a drop-down list of all images added in the previous steps. Pick one of those images, and without changing the Image URL field, click "Insert". Internet explorer will show only partial image if the image size is more than 32 KB.

For efficiency, always start with an existing SPL or template which most closely matches the new SPL you need to create. When creating an SPL from another SPL, be sure to delete the contents of identifier fields (e.g., document and section ids). Simply removing an old identifier will cause the system to automatically place a newly generated identifier in the empty field. When creating an SPL from a template, all identifiers are newly generated, hence there is no need for clearing identifiers when creating an SPL from a template.

For efficiency, use cloning and copy & paste as much as possible. If you need to enter multiple data element structures that are similar (e.g., multiple products that are minor variants of each other or different kit configurations), create one complete product data structure first and use that as a prototype to create the variants by using the clone button [#] or by copy [%] and then paste [&] into another structure. Be sure to have added all data elements for the prototype product and then simply modify them. For example, for 2 drug products with the same ingredients but different strengths create one product with all ingredients, clone it and only edit the strengths.