GlobalSubmit Suite 2010 Beta Test

GlobalSubmit is hard at work on the next version of their software suite.  In addition to several improvements to both REVIEW™ and VALIDATE™, the next update will also include PUBLISH™, their long anticipated eCTD and RPS publishing tool.  As I’ve previously mentioned, I joined the GlobalSubmit team at DIA 2010 and was given a demonstration of an early version of the software.  I was impressed with the new features, and so when GlobalSubmit asked me to participate in their beta testing program this summer, I jumped at the chance.

The GlobalSubmit team provided each of the beta testers – select regulatory professionals along with regulators at FDA and Health Canada – with a laptop that was preloaded with all of the latest GlobalSubmit software.  Each week, GlobalSubmit hosts a webinar in which they introduce a new program or feature and explain its functionality.  Then they turn us loose to test it out on our own and provide feedback.  We have the ability to use demo submission files or to import actual eCTD applications of our own so that we can fully evaluate the software.

So far, I’ve had an opportunity to thoroughly test two of the most exciting new features in the suite, PDF validation and CrossCheck.

GlobalSubmit improved the utility of VALIDATE significantly with the addition of PDF validation to the battery of checks performed on your submissions.  The software now checks every PDF file in your sequence for a host of errors, such as:

• PDF security features enabled
• Application number in the fillable FDA form does not match the actual application number
• Incorrect PDF version
• Broken bookmarks
• Broken hyperlinks
• Incorrect initial view settings

Many of the errors identified by the PDF validation are errors that we currently manually check for as part of our Quality Control (QC) process.  With this information now included automatically in the validation report, our submissions specialists can quickly correct these errors and republish the submission before it ever makes it to our QC reviewers.  This feature will certainly help improve the quality of eCTD submissions while reducing the time required to find and correct errors.

REVIEW also received a noteworthy upgrade with the inclusion of the CrossCheck feature.  This feature is a powerful tool for the QC process.  When you select the CrossCheck function, the window is divided into three zones:

Click for Full Size Image

Zone 1 displays a list of every bookmark and link contained within a selected document.  When you select an entry on the list in zone 1, the actual PDF page that contains that link is displayed in zone 2 and the actual PDF page of the destination is displayed in zone 3.

If you’ve ever QC’d a submission before, you’ve experienced the tedium of clicking on every single bookmark and hyperlink, verifying that you were taken to the correct destination, then going back to the original page and repeat the process for the next link.  CrossCheck will revolutionize this process.

With this feature, you’ll only need to use the “down arrow” key to scroll through each entry on the list in zone 1.  Each time you scroll to the next entry, zones 2 and 3 are automatically updated to display the source and destination PDF pages.  I was able to check bookmarks and links in documents in a fraction of the time it would’ve taken the old way.  I’ve demonstrated this feature for several of the project managers here at Cato Research, and “awesome” was the most common response.

While testing both of these features, the only negatives I encountered were a few minor user interface annoyances that I expect to see improved upon before the final release.

Full Disclosure: Cato Research is a member of the GlobalSubmit Signature Partners program.  However, the opinions expressed in this blog post are those of the author alone and were not subject to approval by GlobalSubmit.

Related articles:

• Advice from Evan Richardson, Cato Director of Reg Ops, for Sponsors New to eCTD (theectdsummit.com)
• DIA 2010 – Week in Review (ask-cato.com)
• Top FDA Processing Issues with eCTD: A Recent Update (theectdsummit.com)