X-Form+Q-and+A

See SPL e-Books for more answers.

Some comments (from [|piercecc]

We've successfully used XForms to complete 13 PIs which list close to 1,000 NDC numbers, without outside vendor help. This wouldn't have been possible without the PragmaticData validator, and a learning how to text edit XML. The XForms does fine if you are listing one or two products on a PI, but starts to bog down even the fastest computers once you get over about 6 products listed. It isn't hung up, if you let it sit for 10-20 minutes after you push each button, it would eventually go.

Here's how we did it....

1) Use XForms to fill out the content of labeling and one/two drug listings. We cut and pasted our PI from a PDF, which seemed to introduce characters incorrectly.

2) Validate at this point to make sure the drug listing is accurate (fix errors before using this as a template to add the rest).

3) Use a text editor (or we found Rustemsoft.com XMLFox Editor (shareware) VERY helpful, because it puts the XML in a nice outline format and you can switch from the code to the view on two tabs). It also has a validate function that helps look for errors in the XML structure.

4) Copy the product going from to and repeat as many times as you need for each product code. It takes some learning, but going through it line by line you can see where the information goes (between "", for example). With all the code there from the template, it doesn't take long to go through and replace all the information to list additional products.

5) Use the Pragmatic validator often. It takes you right to the errors (even if they aren't always self-explanitory).

Just wanted to let people know there are some success stories out there....

[25-Aug-09]

Subject:
Inserting JPEGs using X-forms

Question:
How do we insert images (JPEGs) for SPL using X-forms

Answer:
Here is a slide deck with a pictorial description of the process to be utilized to insert (reference) images in SPL R4 content of labeling/listing documents.



Reference(s) :
This message is one in a series of additional training notes produced by the FDA to assist SPL authors with the creation and/or submission of valid SPL documents.

Subject:
Opening documents in X-forms

Question:
When I’m working with the X-Files that are saved on my computer, I can save them as x-files but then I can not open them?

How do I work on the X-Files and save my data?

Answer:
To save your SPL documents when using the downloadable version of the SPL Xforms to create SPL documents, please see step six in the attached document.

To edit your SPL documents, select the "Open" button, navigate to the location on your computer where the SPL document has been saved and select that file.