CSC releases ''Common Sense'' Validation methodology for enterprise and document management systems; first of its kind for SAP R/3 in the life sciences industry.

CLEVELAND--(BUSINESS WIRE)--Nov. 21, 1996--Computer Sciences Corp. (NYSE:CSC) announced the release of its new Common Sense Validation (CSV) methodology for conducting Food and Drug Administration-compliant validation of new enterprise information and document management systems -- specifically, those built upon packages from SAP Inc. and Documentum Inc.-- in the life sciences and health-care industries.

The SAP segment of the methodology, currently being deployed at several multinational life sciences companies, represents the first of its kind for large-scale validations of SAP R/3 client/server systems.

Enterprise and document management information systems, like other areas related to drug development and production, are subject to strict FDA regulations. Validation of new systems to FDA standards is typically expensive and time-consuming -- particularly if it is being conducted by a life sciences company's in-house information systems or quality assurance staff.

The CSV methodology helps reduce the time and expense associated with such projects by taking advantage of validation best practices from across the industry. Representing the culmination of many labor-years of work, CSV incorporates a high-level strategic approach to validation projects, and a detailed working knowledge of both specific systems applications and industry business processes.

The result is a validation methodology that is efficient, cost-effective and intuitive. Furthermore, rather than simply completing validation tasks, CSV generates useful information throughout the application's life, which enables companies to upgrade their systems or re-test activities more easily.

``Common Sense Validation is a natural evolutionary step from the validation methodologies used for years on equipment and automated systems,'' said Dr. Michael Breggar, the developer of CSV and director of regulatory strategies for CSC's Global Life Sciences Practice.

``Many companies in the FDA-regulated industries have embraced high-level information systems such as SAP, yet the sheer enormity and complexity of these applications have made it difficult for companies to effectively and efficiently validate the systems for compliance with FDA regulations.

``CSV enables us to take the lessons learned from hundreds of past validation projects and apply them quickly to significantly shorten the time frame and reduce the costs associated with the validation project.''

The Common Sense Validation approach is supported by Steven Gaines, director of the pharmaceutical industry business for SAP Inc.

``This is clearly a large step in the right direction,'' said Gaines. ``Common Sense Validation effectively utilizes the tool sets and other information developed by SAP geared toward the regulated process industries. CSC's approach is logical and complete, and ties in nicely with the quality commitments we have put in place at SAP worldwide.''

CSV -- which also can be applied to other applications, such as Laboratory Information Management Systems (LIMS) and Manufacturing Resource Planning (MRP) systems -- generally is deployed as part of a larger business transformation project that spans numerous functions and hundreds of activities. As a result, its emphasis goes well beyond technical considerations.

``Our CSV methodology demands the confluence of highly specialized skills and a broad industry perspective,'' noted Jim Doyle, a vice president with CSC and managing director of the company's Global Life Sciences Practice.

``The professionals conducting the validation must not only know the technology -- in this case, SAP and Documentum -- but also must understand the intricacies of FDA regulations and the business processes unique to the life sciences industry.

``CSC brings all of that to a project, in addition to expertise in managing large-scale initiatives and helping companies define and prepare for the future.''

CSC combines strong industry expertise 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 $5.2 billion and nearly 40,000 employees in 600 locations worldwide, CSC has been serving a wide range of industries and government entities for nearly 40 years.

CONTACT: Computer Sciences Corp.

Bernie Thiel, 216/449-3600, ext. 2277

[e-mail]