Quality Pitch
Harris says that when she speaks with pharmaceutical companies, her pitch concerns quality management systems based on enterprise content management (ECM) technology. But she notes that although the term “ECM” is a familiar one across many industries, it is not necessarily appropriate for the life science industry. “I talk about ‘content lifecycle management,’ which is more about how they see processes, rather than the capabilities of the systems.

“We get concerns about records management and archival capabilities; it’s unique to this industry,” says Harris. “Customers ask about archival formats. They want to be able to access documents and records years from now.”

Functions First
In many cases, and in spite of the “enterprise” in ECM, early pharmaceutical customers started by building applications for such particular functions as clinical trial management or CAPA. “Customers are now coming back saying, ‘We have a quality group that’s using the platform, as well as other groups. We are now seeking enterprise integration,’” says Harris.

The Open Text system is Web based, so users have found that they can build applications on top of the content management platform.

“Creating enterprise transparency is a major challenge [because] the product development stages become segmented between departments, and content does not transition efficiently through the phases of the drug life cycle. Inconsistent processes can lead to not only project [slowdowns] but also legal and regulatory risks,” adds Brett Shellhammer, Open Text senior vice president for business solutions, in a company statement last June.

In highly regulated businesses, transparency comes down to content management.

Managing Business Processes
A May survey conducted by AIIM-The Enterprise Content Management Association, in Silver Spring, Md., found that users are seeking to leverage their ECM investments through a systematic focus on organizational processes. For many, that focus is taking the form of business process management (BPM) initiatives.

The study found that, although most of the more than 800 responding organizations have begun BPM initiatives, there are few best practices. “The BPM market is at a relatively less mature stage than the ECM market,” states AIIM President John Mancini, in a July announcement of the results.

Information technology and records management specialists each represented 23% of the survey participants, followed by those focused on document management (18%), senior executives (9%), and line of business managers (8%).

A Difficult Task
“There are many challenges to doing it right,” says Carl Frappaolo, AIIM’s vice president for market intelligence. “BPM initiatives must be preceded by clear executive leadership and detailed process design.”

Many are not, it seems. Some 36% of respondents reported little to no success with their BPM initiatives. AIIM attributes this response to several factors, including the fact that some respondents have not yet undertaken a BPM initiative and the reality that such rollouts are, in fact, difficult. Some 16% reported an “initially difficult” rollout, yielding 52% whose impression is either initially or completely negative.

Some of this difficulty may be due to discrepancies in the way implementers view the relationship between business process management and enterprise content management. In a separate state-of-the-ECM-industry survey conducted by AIIM earlier in the year, 30% of respondents reported that they see BPM as a subset of ECM, while 26% see ECM as a subset of BPM.

Further Integration
BPM also requires integration with other existing corporate systems, further complicating implementation. Yet most organizations reported an expected payback period of three years or less, said Frappaolo.

Some 68% of respondents identified a specific group within their company as responsible for BPM, yet no single group emerged across industries. The information technology (IT) group was the number one identified owner of BPM but received only 21% of responses.

Also, only 22% of respondents reported cross-department/enterprise-wide installations with BPM. Some 32% reported implementation at the departmental level only.
Half of the survey takers were from large organizations – more than 1,000 employees. Midsize companies of 100 to 1,000 employees comprised 26%, and the remaining 24% were from small organizations.

Harris of Open Text says that when prospective pharmaceutical company clients first approach her, they are often at the clinical trial stage. Their first conversation sometimes begins this way: “I have too much paper here…it’s all over the place…I’ve got to get my regulatory content under control!”

But “it’s not just about regulated content anymore,” she says. “It’s about choosing a cross-enterprise platform: controls, litigation support, document management, finance, legal. There are lots of different stakeholders saying, ‘We want our process sitting on your platform.’”

Document Management Plus
For example, in vitro diagnostics company BioMérieux (Marcy l’Etoile, France), which in late July launched VIDAS C. difficile Toxin A&B, a test for the detection of a bacterium responsible for fatal nosocomial epidemics, sought an electronic document management system. The group, which designs and markets systems used in clinical and industrial applications and provides related services for the installation and maintenance of instruments, worked with Open Text and wound up with much broader capabilities:
• A regulated document lifecycle, from creation and editing to approval, publication, and records management;
• The capability for employees to set milestones and dates and receive alerts and e-mail notifications;
• Integration with the company’s existing enterprise resource planning system, enabling direct printing, reprinting, and error report generation upon failure;
• Audit functionality;
• Process consistency and conformity; and
• Support for FDA recommendations.
In another example, Purdue Pharma (Stamford, Conn.) chose Microsoft Corp. (Redmond, Wash.) and Interse A/S (Washington, D.C.) to help automate and enhance the management of its clinical trial documentation.

The Purdue document management solution is based on Microsoft Office SharePoint Portal Server 2003 and Interse’s iBox metadata management and search solution. Purdue uses the solution to create clinical project document sites.

Simplified Search
“Before deploying Office SharePoint Server and iBox, our staff could spend days trying to find a document,” said Anthony Sclafani, assistant director for collaborative business solutions at Purdue, in an announcement. “Sorting through file shares was a manual process, which was a problem with multiple financial and logistical implications.”
Purdue is known for its research on persistent pain. Like all pharmaceutical companies, Purdue produces hundreds of thousands of pages of documentation per clinical trial. The iBox solution integrates and supports Office SharePoint Server 2003, providing metadata management and search capabilities. For instance, the company is now able to automatically associate up to 38 industry-specific metadata tags with each document, enabling more relevant searches and helping users search across documents in new ways.