BEDMINSTER, New Jersey and SUNNYVALE, Calif. -September 15, 2003- Entology, a consulting organization that specializes in enterprise technology solutions for the Global 1000, and Interwoven, a world-leading provider of content management software for the enterprise (Nasdaq: IWOV), today announced 21 CFR Part 11 computer system validation services for the Interwoven content management platform. "21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule," provides guidelines that organizations must follow if they use electronic records and electronic signature systems. Since Part 11's inception in August of 1997, the Food and Drug Administration has required compliance from all life science companies, and Entology's validation services for Interwoven content management ensures that such organizations are meeting these critical record-keeping and documentation rules and regulations.

"Validating a computing system to ensure Part 11 compliance can be a difficult and time-consuming task, requiring a deep knowledge of the rule's provisions and requirements," said Stephen Lombardo, director of Enterprise Solutions at Entology. "The core purpose of validation to Part 11 standards is to provide a high degree of assurance that a system is reliably performing according to its requirements and specifications."

As such, validation typically requires the development of very specific deliverables including a Validation Plan, Functional Requirement Specification (FRS), System Design Specification (SDS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Plan, Test Scripts, Traceability Matrix, and a Validation Summary Document. Deep knowledge of the technical platform being validated is absolutely critical for efficiency in these tasks. By combining strong technical knowledge of the Interwoven platform with a firm understanding of 21 CFR Part 11 requirements, this alliance provides a single source for validated Interwoven implementations.

Because Enterprise Content Management platforms often include electronic records management functionality, system validation services are frequently requested for the Interwoven platform. "We count eight of the top 10 global pharmaceutical companies on our client roster," said Rex Thexton, vice president of Enterprise Solutions at Entology. "We clearly understand that compliance is one of the most critical issues facing today's pharmaceutical, medical device, and bio-tech firms. Because we have experience delivering 21 CFR Part 11 validation services for the Interwoven platform, Interwoven and Entology are uniquely positioned to deliver compliant Enterprise Content Management solutions for life science organizations." Entology and Interwoven have been partners since 2001, and have delivered numerous content management, portal, Web Service, and customized business solutions for mutual customers, including Novartis, Wyeth, GlaxoSmithKline, and ACE Re-Insurance.

Interwoven and Entology Deliver Customer Success

Entology recently demonstrated its capabilities by designing and deploying a Part 11-compliant Interwoven implementation for a top-ten pharmaceutical organization. The system provided a Web-based content management service from Interwoven that streamlined publication of product data to the company's extranet. During the engagement, Entology's Part 11 experts used a proven methodology to clearly define and support the client's validation requirements. At the end of the engagement, Entology delivered approved and executed documents to the customer for record-keeping purposes as required by Part 11. Additionally, while Entology's validation consultancy was ensuring the solution would be Part 11 compliant, product experts provided full life-cycle services including the development of Interwoven TeamSite content management software templates, workflows, and custom components. Entology has continued to support the solution with required updates to the documentation and code product.

According to John Bara, senior vice president of marketing at Interwoven, "We recognize that 21 CFR Part 11 compliance is critical to our life science customers to safeguard their internal processes while meeting increasingly demanding government regulations. Through this alliance, Interwoven and Entology are positioned to provide a broader range of business-driven validation services for all Interwoven products."

Entology has deployed integrated solutions with the Interwoven product line that provide a wide range of services including: taxonomy/metadata management, Web content management, advanced document management/renditioning, portal service integration, and consolidated hosting infrastructures. In addition to developing custom solutions, Entology provides a full set of standardized JumpStart, HealthCheck, and Value Assurance offerings focused on the Interwoven platform.

Entology specializes in architecting, developing, and implementing enterprise technology solutions for the Global 1000. Ranked as North America's fastest-growing IT consulting firm by Deloitte & Touche in 2002, Entology brings specific expertise to its clients in the areas of enterprise content management, document management, web services, enterprise portals, identity management, security services, enterprise architecture, business solutions strategy, solutions engineering, knowledge optimization, and data warehousing. Entology is a privately held and self-funded corporation that has garnered profits every quarter since its founding in 1997. For more information visit http://www.entology.com.