Don Bridges interviews Bernie Coney of Wyeth Pharmaceuticals and learns how one division of the company moved to a standard because they needed to meet regulatory compliance, but soon realized it also helped them achieve consistency, efficiency, and higher-quality documents. Now they are taking that message to senior folks at Wyeth to say that this technology not only offers compliance, but can also increase efficiency-and they have the data to prove it.

Don Bridges (DCL): Bernie, first of all, can you tell us what you do at Wyeth?

Bernie Coney: I work in the labeling group. Our department supports the U.S./European labeling and the company core data sheets. I work in the operations group where we support SPL (Structured Product Labeling), submission-ready documents, and as part of that, I also head a project that is focused on structured content; implementing tools to support the labeling group--mainly with XML.

Don: You mentioned XML, What was the catalyst for Wyeth to get interested in XML?

Bernie: We originally looked at PIM (Product Information Management, a European regulatory standard) and SPL as two health authority driven standards that both employed XML technology. So we formed the project to really look at the tools that were available on the market to try to enhance the business by using XML as a common solution.

Don: So it sounds like with XML, there were both some compliance issues and some of what I'll loosely call business issues. Maybe focusing on the business side, what business issues do you see XML solving at Wyeth?

"…quality and efficiency improved because we're editing documents once, and in an editing session, you can create all your changes in XML. By rendering from XML, you get the multiple outputs that you need."

Bernie: We have, as any large organization would, typical document management challenges within labeling. We create multiple versions of the label; some for submission to a health authority, others for different groups within the company that use the labeling. Having different versions of a document presents the challenge of ensuring high quality. The challenge can be to make sure that the text is consistent across all these documents. What I think we've seen from XML is that it applies consistency to the formatting and content, because you extract the content and the format, which helps resolve some of our document management challenges. We've seen the quality and efficiency improved because we're editing documents once, and in an editing session, you can create all your changes in XML. By rendering from XML, you get the multiple outputs that you need. There were obvious compliance commitments that required SPL but I think the other side is efficiencies, greater consistency, and higher quality with the use of XML.

"…the other side is efficiencies, greater consistency, and higher quality with the use of XML."

Don: But as I'm sure you realized, XML is not a free ride. There are some expenses with it. When you're presenting the concept of XML to your management for buy-in, do you present it as a compliance solution or as a business solution?

Bernie: I would say for the better part of the three years that we've been working on the project, it's been around compliance. With PIM and SPL, the driver when you talk to management is around compliance but I think lately, we've looked at some of the other things we've been talking about,

"…this technology not only offers compliance, which is the more obvious business case, but can add greater efficiency."

which are efficiency and quality. We've seen improvements in turnaround time internally for the group that renders documents and its metrics have improved over the last year. Those are some of the messages that we're now starting to take to senior folks at Wyeth; to say that this technology not only offers compliance, which is the more obvious business case, but can add greater efficiency. And we've seen data that shows that we're improving the business process.

Don: So there's been a transition from the compliance side to a "Hey, this can make us be faster, quicker, and smarter in the way we do our business."

Bernie: Yes.

Don: Very interesting transition. We've heard some content creators are very reluctant to adopt XML authoring tools. Is that the case that you've seen at Wyeth, and how do you handle it if it is?

"I think we've developed expertise within a small segment of our group initially so they got very savvy with XML and then started to branch that out to the larger user group."

Bernie: I think the biggest challenge that we've faced was moving people from Microsoft Word to an XML editor. If you think about how broad the use of Word is in people's daily lives. Within our labeling group, they used Word for so much of what they do day to day. When we switched to an XML based process, it was really challenging to move users who are non-technical users, people with backgrounds in science, to XML. It was a challenge mostly around the formatting and the usability of the tools. The feedback that we received from our users was that our editor was not user-friendly. But I think we've seen in working with different vendors that there's a real push towards user-friendly editors. I think the shift from Word, which has a sort of unlimited formatting, user friendly editor, to XML which is much more structured, brings with it the challenge of really priming your users to explain why the technology is beneficial. That took a lot of effort on our part. I think you can say we did a lot of work to educate the users on XML. But if the tool is much more intuitive, you may have to do less of that educating.

Don: So it sounds like training is a critical piece of the process as well.

Bernie: Yes.

Don: How important has it been to get users involved early and develop what I'll call "super-users" to help you come up with a working solution that would be adopted by the people that are actually going to be using the tools?

"Because we developed the expertise internally, the "super-users" kind of get empowered."

Bernie: I think we've done a good job of partnering with our IS team, and we involved the users from the requirements stage through the user acceptance testing phase of our project. I think we've developed expertise within a small segment of our group initially so they got very savvy with XML and then started to branch that out to the larger user group. But, I think the "super-user" concept helped create ownership of the technology, which was good, and it created peer to peer mentoring and help in a very constructive way for our group. Because we developed the expertise internally, the "super-users" kind of get empowered. They own the technology and they can help foster confidence, which aided change management. They liked it, and they understand that the tool has benefits, so that when they're working with a new user of the tool-- a person new to XML--they're there giving the good messages and the pep talks and pushing people forward. So, I think it's been really critical to the project, and I think it's been a great change management tool.

Don: Well Bernie, that's some great insight. I do appreciate you sharing your thoughts with us. Thank you very much!

DCLNews
August 2008