CASE DESCRIPTION

Due to the Food and Drug Administration's mandate that all New Drug Applications be submitted in the electronic or paperless format (FDA Proposes First Requirement For Electronic Submissions, 2002), many information technology changes are taking place within Bayer Pharmaceutical. While most of the expenditures for the pharmaceutical industry are in the form of scientific research and development, many companies are now being forced to focus more on information technology. Bayer Pharmaceutical is not unique and its neglected document management system is now of prime concern and focus. In fact, one of its major competitors, Purdue Pharmaceutical, has already begun using such a system for the submission of NDAs. According to Martin Zak, Director of Information Technology:

"Our goal at Purdue Pharma is to become one of the top ten pharmaceutical companies within the next ten years. One of the keys to achieving this goal is by using Documentum 4i eBusiness Platform to manage the content of our company's strategic assets. With Documentum 4i, we will be able to streamline the approval process and speed products to market without sacrificing quality or safety. In this way, Documentum not only helps us but also helps the patients we ultimately serve." (Purdue Pharma L.P.: Speeding Time to Market with Documentum 4i, 2001)

Bayer faces many of the same challenges, yet there are different systems and procedures for each department within the company. Unfortunately, this autonomy is not productive and makes complying with government regulations virtually impossible, reduced efficiency and expanded cost notwithstanding. There are also multiple systems, many badly outdated, currently in use. Separate applications for storing documents electronically, archiving documents, compiling information for submissions, interacting with foreign databases, and retrieving statistical analysis all require valuable resources to maintain. Furthermore, most of these systems do not communicate well with one another or other departments such as statistics or project management.

Thus, Bayer's critical business challenges for the short term are to find new ways to implement its processes in light of the electronic NDAs. Its competitors, such as Purdue Pharma and Boots Healthcare, have already begun this process. They propose to use technology to:

• Foster high growth within a competitive marketplace and accelerate time-to-market for new products while adhering to stringent Food and Drug Administration (FDA) deadlines and compliance requirements necessary for approval.

• Virtually assemble content, securely and efficiently control the flow of content, authorize and verify recipients, and track changes involved for submissions to, and compliance with, regulatory agencies. A missed paperwork deadline can mean a six-month delay in the approval process and impede time to market.

• Manage multiple forms of content from content owners at multiple sites throughout the world and publish to an internal Web site.

• Meet regulatory compliance for manufacturing, standard operating procedures, and training documents. Be able to produce documents on demand, decreasing potential future audits. (Purdue Pharma L.P.: Speeding Time to Market with Documentum 4i, 2001)

By using a validated system for document management such as Documentum (like Purdue Pharma and Boots Healthcare have done), Bayer will be able to comply with the new FDA regulations, something not possible with the manual legacy system. Without superior technical support for many of the legacy systems, downtime will increase. All these factors lead to a forced decision to update. While there has been talk of a new document management system for some time, only now is it becoming reality.

The new system is currently undergoing many new challenges. The validation process and changeover are taking place at the same time. Instead of having a system in place and then using it for submission purposes, Bayer is developing standard operating procedures and using these new procedures at the same time. Furthermore, the legacy system is not being phased out. In fact, it has been the central archive for so many years, yet it cannot properly communicate with the new system. While the large-scale use of this legacy system will eventually be discontinued, it is not certain if it will ever disappear completely. What adds to the problem is that the old system was designed and built in-house for specific functions. The long-term goal is to integrate the old and new systems to take advantage of the current technology's speed and power (Supporting pharmaceutical research and development, 2001).