Outer package in package group is the innermost package in the real world, you can check in SPL View.Outer package in package group is the innermost package in the real world, you can check in SPL View.You must provide your electronic signature in the preceding field. An electronic signature is any symbol attached to or logically associated with this submission executed by you with the intent to sign this submission and the above statement.

Pragmatic Structured Product Labeling Editor ("SPL XForms")

Copyright (c) 2010 Pragmatic Data LLC. All rights reserved.

It appears that your browser installation is unable to run Java applets. In order to use this form Java applets must be working. Refer to the section "Java Required" on the Help tab for more details. Please also refer to the FDA SPL XForms web pagefor troubleshooting help and other advisories.

 Template

HeaderData ElementsContent Of LabelingSPL ViewClipboardResultXML ViewHelp Show Metadata This is related to Medicated Feed Mill

To begin, load an existing file or select template and press the "Load Template" button. When creating a new file, begin by choosing a template that most closely matches your use case.

Technical Notes

Note on Browser Comparability: the Pragmatic forms work with Mozilla Firefox (6 and higher), Internet Explorer (IE, 7 and higher, up to 10 but not yet including 11), Google chrome (8 and higher) and Apple Safari (4 and higher). The forms work much faster in Internet Explorer 8 than Internet Explorer 7. We recommend Mozilla Firefox.

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.

Java Required

Currently the Pragmatic forms require working Java applet support. Without applet support some limited functions can work, but a red note will appear, informing that Java applets are not working.
We recommend to clear Java applet cache whenever Java applet is upgraded.
Steps to clear Java cache:
Java Control Panel (In system Settings -> Control Panel)-> General -> Temporary Internet Files -> Setting... -> Delete Files ...
check Cached Applications and Applets and then click on Ok.

Add SPL link in Exception Site List
Below are the steps to add SPL XForms link to Exception Site list for latest Java version -
1. Go to Control Panel --> Programs --> Java
2. Go to Security tab --> click on Edit Site List
3. Click on Add button to enter the URL.
4. Enter the URL of pragmatic SPL Xforms as http://pragmaticdata.com/spl/form/ (Do not forget to put forward slash at the end of the URL)
5. Click on OK button after entering the URL location. This will open Security Warning panel.
6. Click on Continue button to accept the entered URL location.
7. Ensure that entered URL has been added in the Exception Site List.
8. Click on Ok button to exit. And now load the SPL xforms from http://pragmaticdata.com/spl/form again. This will successfully load the SPL xforms.

If you do not require the ESG Gateway, install the latest Java from http://www.java.com/en/download.

If you required ESG Gateway on same computer, please follow the ESG Gateway instructions to update to most recent Java which ESG supports.

If the browser shows a dialog asking for permission, allow it. For example,
1. If the browser shows a dialog "Do you want to run this application?", allow it and check the "Do not ask again" checkbox option (which appears on clicking the "show options").
2. When using IE there may be a warning dialog box, saying "This application would like to use an old version of Java". You should choose Run with latest version, OK to proceed further.

 
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"Internet Explorer Running Slow" Warning

To avoid, Internet Explorer running slow warning. For some operations, internet explorer may give a warning message - "A script on this page is causing Internet Explorer to run slowly..." To avoid this message, To avoid this message, donwload and save this link. Execute it from this link itself or execute the downloaded file using mouse double click. Try form operations after restarting Internet Explorer. Note that this needs to be done only once.

Usage

Tabs exist to split the form up and make it easier and faster to navigate. The header tab is general document information. The Data Elements tab is for product and indexing data elements. The Content of Labeling tab is for the document text sections. SPL View shows how the currently created SPL will look in the browser. XML View is the full XML of the SPL and allows editing the XML directly. Compare is for comparing 2 SPLs. Help is this tab you are currently looking at. 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 collapsable 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. You can further add or remove data elements by clicking on the lightweight buttons, which are marked by single-letters in square brackets, such as [+], [-], [R], etc. To understand the meaning of the other buttons, you can hover with the mouse cursor over them to see a tool-tip explaining the function.

There are 3 standard buttons which always have the same function [+] adds an item of the same kind, [-] removes the present item, and [#] 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.

To save a file, press the "Save" button. The file name of the new file will always be the document id with the '.xml' or '.zip' extension. To save a file created from a template for the first time, or to save the file at a different location, press the "Save In" button and choose the location (folder) with the file browser. The file will be saved in that folder under the document id with '.xml' or '.zip' extension, so it is not necessary or possible to choose a different name.

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 the image will not be uploaded and the form will display the 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. To ensure the text box height is resized, you may need to press the return key entering a line break.

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.

 
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Advanced Options
Temp  Repository URL URL localPath path imagePath Show Clipboard

For help, click the "Help" tab. Refer to the FDA SPL XForms web page for troubleshooting help and other advisories. For any remaining unanswered questions email may be sent to spl@fda.hhs.gov and spl@pragmaticdata.com.


Copyright (c) 2010-2012 Pragmatic Data LLC. All rights reserved.

Government Restricted Rights Legend:The Pragmatic XForms SPL product is restricted computer software under the provisions of FAR 52.227-14 with Alternate III under the contract HHSF223200950194P and FAR 52.227-19under the contract HHSF223201110180C, Pragmatic Data LLC grants to the FDA a perpetual, non-exclusive, and non-transferable license to use the product and to permit the public to use the product through websites operated by the FDA. Any other rights regarding the use, duplication, or disclosure of this computer software, according to FAR 52.227-14 Alternate III (d), shall be specified as follows:

The FDA may distribute the product to the public through a redistributable file delivered by Pragmatic Data to the FDA for this purpose. The license to redistribute this file shall be granted only to the FDA and is not transferable and not assignable to other parties. Pragmatic Data grants to the public receiving this file from the FDA a perpetual, non-exclusive, and non-transferable limited license to use the product at no charge. "Use" of the product shall mean to manually encode SPL content for data submissions to the FDA, but not to make the product available to others and not to embed it into larger works or web sites.

Under the restricted rights in data clause, Pragmatic Data reserves the right to modify the software and reserves all rights of redistribution of so modified software.

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