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Computerworld - Pfizer Inc. is embarking on an effort to consolidate more than 30 document management systems in order to streamline regulatory submissions.
At the same time, the New York-based drug giant has started an effort to standardize on XML for authoring to meet new federal regulations.
The projects stem from the challenges associated with meeting new submission requirements from the U.S. Food and Drug Administration and other agencies, said Christopher Lee, director of worldwide regulatory operations at Pfizer.
A consolidated content management system will allow the company to meet these evolving submission requirements without having to deploy tactical point solutions or revise content multiple times, Lee said.
Pfizer plans to build the content repository by using technology from the Documentum Inc. unit of Hopkinton, Mass.-based EMC Corp.
The content management system consolidation will span operations in 26 countries and different corporate groups such as research and marketing to create one seamless flow of information to support regulatory submissions, according to Lee.
The company is also defining "authoritative sources" of content so information about a single subject -- such as a drug compound -- can be limited to one location.
Consolidating content management systems will likely allow Pfizer to more easily integrate content needed for regulatory submissions that may now be created on disparate systems, said Nathaniel Palmer, an analyst at Delphi Group in Boston.
"It will be a huge effort ... if they're able to do it successfully, the advantages would be tremendous around the life cycle of information and being able to trace back to the origins of that information," Palmer said.

Consolidating Pfizer's content management systems should improve the work done in its laboratories, the pharmaceutical company says. Image Credit: The Associated Press

At the same time, Pfizer plans to convert all of its regulatory submission-related content from Word to XML.
Beginning in October, the FDA will require that pharmaceutical companies submit changes to product labeling in an XML format. Most pharmaceutical companies, including Pfizer, now deliver these changes in Word documents.
Pfizer will decide in the next 30 days whether to use an outside vendor to convert existing documents to XML or build in-house tools to do the job.
The company plans to create documents directly in XML by using tools from Arbortext Inc. in Ann Arbor, Mich., Lee said.
In parallel, the company is building a common template that can help in the process of converting Word documents to XML.
"From a business standpoint, Word right now introduces the opportunity for variability," which hinders efforts to standardize company documents,Lee said.
In addition, an XML-based authoring system will allow the people writing the content -- often physicians -- to focus solely on content without having to worry about structure of the document, he said.
However, Palmer noted that there will be cultural challenges associated with migrating authoring to XML. "You have fiefdoms ... that aren't going to easily change," he said.

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