CDC Solutions Unveils EZsubs Compliance for Regulatory Publishing in Life Sciences.

Business Editors/Hi-Tech Writers

PHILADELPHIA and CHIPPENHAM, U.K.--(BUSINESS WIRE)--March 11, 2002

Out-of-the-box solution with integrated content management system

meets strict requirements of worldwide regulatory bodies

CDC Solutions Ltd. (www.cdcsolutions.com), the leading global provider of document-based solutions to the Life Sciences industries, today announced the availability of EZsubs(TM) Compliance for regulatory submissions publishing.

EZsubs Compliance helps companies manage the generation and delivery of high-quality content for the whole of the submissions publishing process in one "out of the box" solution. Complete with a built-in Documentum 4i(R) content management (CM) system and CDC Solutions Professional Services, this latest addition to the EZsubs suite offers the scalability essential for growing companies, while providing all the necessary functionality to meet the strict requirements of the European Medicines Evaluation Agency (EMEA), the U.S. Food & Drug Administration (FDA), and other regulatory bodies throughout the world.

Philip Padfield, Chief Executive Officer of CDC Solutions said, "Bringing a new product to market involves supporting a highly distributed, collaborative R&D process with massive volumes of content. This content takes the form of information from clinical trials, case reports, and other important research produced during the development phase. With a manual process, assembling this information and presenting it in a form acceptable to the regulatory authorities takes precious time out of a product's patent protected life and may jeopardize the `first to market' opportunity. To streamline this business process, companies are implementing content management and delivery technologies, utilizing a highly automated electronic publishing system to perform more work with fewer resources. This also speeds the approval process by improving information accuracy and consistency, which equates to an improved and accelerated revenue stream for the submitting company."

EZsubs Compliance is a complete solution for companies wanting to achieve electronic regulatory submissions with minimum time taken for installation and roll-out of a complete CM system.

Offering version control, the ability to audit the entire lifecycle of the approved documents, and fully automated electronic submissions publishing from one integrated platform, EZsubs Compliance includes those functions of a CM system that enable companies to meet regulatory requirements including 21 CFR Part 11.

This, and similar rules, establishes what is needed by the FDA and other regulatory agencies to ensure that electronic records and electronic signatures are trustworthy, reliable, and generally equivalent substitutes for paper records and traditional handwritten signatures.

Compliance with these rules is essential for demonstrating to the regulatory bodies that proper reviewing, auditing, and versioning of documents has been maintained throughout the R&D process.

Jim Cook, Chief Technical Officer of CDC Solutions added, "Because we focus entirely in the Life Sciences arena and we listen carefully to what the regulatory bodies and our customers tell us, we are able to develop turnkey systems that are both technically sleek and functionally relevant. We design our technology specifically for compliant content delivery, complete with all the components necessary to be installed and rolled-out quickly and seamlessly, thus minimizing the time and additional resources required by consultants and clients' IT staff to implement the solution."

Key Benefits

EZsubs Compliance is designed to simplify and standardize the regulatory publishing process, enabling improved product time-to-market and longer revenue within patent protection. Among the key benefits of EZsubs Compliance are:

-- Achieve regulatory compliance of 21 CFR Part 11

-- Compile information from multiple file formats

-- Manage the whole submissions document lifecycle

-- Repurpose information assets

-- Apply submissions templates for multiple regulatory requirements

-- Dramatically improve efficiency

While satisfying the latest regulatory guidelines immediately, these benefits allow highly automated compilation of compliant electronic output, and facilitate reports and submission content that can be easily leveraged for future needs.

Product Availability

EZsubs Compliance is now generally available for shipment to customers, and requires minimal additional equipment to run on Windows 2000. Installation services and product training are provided for effective implementation, deployment, and end use. For pricing and additional information, contact CDC Solutions at [phone] in Europe or 610/834-9021 in the U.S.

Product Demonstration Seminars Scheduled

CDC Solutions is offering free Web-based seminars on Wednesday, March 27 and Thursday, March 28, 2002 to deliver an overview and live demonstration of EZsubs Compliance. Seminars in English, French, and German will be offered throughout each day to accommodate global languages and time zones. Visit www.cdcsolutions.com/WebSeminars.asp to register.

About CDC Solutions Ltd.

Founded in 1994, CDC Solutions is the leader in high performance document-based solutions to the Life Sciences industries. The open, flexible technologies developed by CDC Solutions enable Life Sciences companies to meet the strict standards of regulatory authorities across the world, helping them achieve quality, accuracy, and data integrity to deliver reports and submissions reliably on time.

CDC Solutions helps compress the regulatory submissions and approval process, improving speed to market, cost control, and productivity: all of which contribute to ensuring patients' and physicians' timely access to new drugs. CDC Solutions develops products in-house, employing a team of developers and regulatory specialists who actively pilot new initiatives with clients and partners. Through its strategic business partners, CDC Solutions' technology is used to address the needs of other document intensive industries such as engineering, utilities, and finance.

For more information, call [phone] (United Kingdom) or 610/834-9021 (CDC Solutions Inc., North America), or visit the CDC Solutions website at www.cdcsolutions.com.

CDC Solutions, CDC Solutions Inc., EZsubs Publishing Suite, PDFfusion, PDFrender, PDFaqua, PDFtools, PDFcontrol, Xport and Xtensia are trademarks or registered trademarks of CDC Solutions Ltd. All other product and company names mentioned herein are trademarks of their respective holders.