Every pharmaceutical company is concerned about the potential business impacts associated with structured product labeling in SPL and PIM. As the time for implementation approaches, and as more is understood about the degree of complexity that will ultimately be involved, the concern is growing.

Part of this concern arises because this is not the first time the pharmaceutical industry has looked at XML authoring, and what they saw in the past did not go over well. Pharmaceutical companies have understood the benefits of XML for years—they have also seen the “demos,” tried the products, and went away convinced that an XML editor was not a tenable tool for knowledge workers who were under pressure to produce critical documents.

Perhaps that is why a few industry executives sought out In.vision early last year—once it became clear that XML documents were not just a “good idea,” but something they would be required to do. These executives heard of In.vision’s success in deploying XML authoring of very complex documents in other industries, and wanted to know why it worked.

"I was not sure what to expect before attending the In.vision SPL workshop, but there is a clear rationale as to what is being done. I am comfortable that the product will be easy to use and learn."

"Now I feel better because I did not need to learn XML."

What these executives found is that while the technology behind In.vision’s success is very sophisticated, the business rationale is simple: In.vision’s Xpress Author allows people to create documents in Microsoft Word just as they always have.

With In.vision, XML is no longer a disruptive technology. Introducing XML word processing in Microsoft Word to authors is a breeze, especially when compared to the struggles that occur when users are forced to deal with the technical complexities of an XML editor.

In June of 2004 CDER organized an “SPL Challenge,” designed as an open forum where vendors could demonstrate their SPL solutions. In.vision submitted the required valid SPL document to the FDA just one week after learning of the challenge, and presented a solution that impressed the audience with its simplicity.

"I really think that the tool we use for creating the structured labels should resemble Word as much as possible."

"I was surprised that Xpress Author for Word could provide an automated database of drug properties: active ingredients, forms, etc."

Since then, Xpress Author has been tested in the field through hands-on workshops and Proof-of-Concepts with actual authors. The results are in: the Xpress Author SPL Accelerator has won overwhelming favor. Xpress Author has quickly become the leading solution for XML authoring of knowledge documents in the pharmaceutical industry, joining the other industries where this was already the case.

On March 18, 2005, the FDA revealed that Xpress Author would be used for review and commenting of submitted SPL documents in the ELIPS system that is to be implemented by Northrop Grumman and its partners.