CSC announces creation of task force to help pharmaceutical companies deploy electronic records.

WALTHAM, Mass.--(BUSINESS WIRE)--May 27, 1997--

Will explore practical strategies to address business process

implications

In response to the recent Food and Drug Administration ruling that recognizes the validity of electronic records and signatures throughout the FDA-regulated healthcare industries, Computer Sciences Corp. (NYSE:CSC) has formed a task force to develop practical strategies for companies that wish to employ such technologies.

The final rule on electronic records and signatures (Federal Register Volume 62, Number 54), issued on March 20, 1997, described "electronic records, signatures and handwritten signatures executed to electronic records as equivalent to paper records..." This rule, according to CSC's Dr. Michael Breggar, is a great step forward in the industry's ongoing efforts to streamline the compliance process. However, he said, while the current technology supporting electronic signatures and records is robust and up to the task, many of the business processes in the healthcare industry are not.

"The electronic records and signature software and hardware on the market today are quite powerful, and have the potential to greatly help pharmaceutical, biotechnology and medical device companies to manage more efficiently the vast amount of information generated in relation to compliance," said Breggar, head of regulatory strategies at CSC Healthcare, the CSC unit spearheading the task force. "But the implementation of such technology has wide-ranging impacts on existing business processes -- most of which were designed to accommodate only paper records.

"As a result, these companies need to develop new strategies for not only integrating the technology into their organizations, but also for changing the ways in which employees work and communicate with each other."

As an example of how these technologies can affect a company's established processes, Breggar cites the routine practice of document management. The use of electronic technology for this task will allow multiple authors and reviewers to interactively create and approve documents (protocols, procedures, etc.), from multiple locations.

CSC's task force -- comprising 15 consultants from CSC Healthcare, three professionals working for pharmaceutical companies and one representative from the FDA -- is building a set of ground rules and parameters from which an effective deployment strategy for electronic records and signatures can be devised. These concepts are based primarily on task force members' knowledge of the industry and best-practice experiences in the delivery of similar systems and strategies in other regulated industries.

The ground rules and parameters address:

-- Employment/deployment strategy

-- Assessment methodology for effects on current systems

-- Cost/risk/benefit considerations

-- Means to incorporate the technology into an existing

infrastructure

-- Data collection and retention rules

-- Scope and boundaries of regulated vs. non-regulated functions.

In the future, the task force will focus its attention on determining the best practices for assessing and upgrading processes and systems to incorporate the new electronic record requirements. "This new rule has opened the door to the expanded use of electronic systems in the medical industry," said Breggar. "However, clear guidelines and a solid understanding of how to best utilize the technology will be necessary for the industry to seize the opportunity."

CSC combines strong industry experience with deep technology capabilities to help clients solve critical business problems. Specialized areas of expertise range from business process redesign and information technology transformation to large-scale systems integration, custom application development and outsourcing. With revenues of $5.6 billion and 44,000 employees in 600 locations worldwide, CSC has been serving a wide range of industries and government entities for nearly 40 years. For more information on CSC, visit the CSC Web site at http://www.csc.com .

CONTACT: Computer Sciences Corp.

Bernie Thiel, 216/449-3600