Telelogic DOORS® Gains Ground in Medical Device and Pharmaceuticals Market

Telelogic DOORS® Gains Ground in Medical Device and Pharmaceuticals Market Telelogic DOORS® Supports FDA Audit Requirements MALMÖ, Sweden and IRVINE, California - December 18, 2002 - Telelogic, (Stockholm Exchange: TLOG), the leading global provider of solutions for advanced systems and software development, is expanding its presence in the medical device and pharmaceutical industry. With the ubiquitous use of computers and software in the industry for the capture and storage of data, the federal Food and Drug Administration enacted Title 21 CFR 11, a broad regulation that governs the creation, verification and archiving of electronic records. "The integrity of the record is very important, both during generation of the record and as records are kept, to document safety, efficacy and quality," explained Alan Goldhammer, associate vice president for regulatory affairs at PhRMA (Pharmaceutical Research and Manufacturers of America). "The scope of the regulation is quite extensive, and we need electronic signatures and validation throughout the process." Increasingly, FDA-regulated companies are turning to Telelogic DOORS to gain traceability, reliability and confidence in their electronic data. DOORS, the world's leading requirements management tool, is a multi- platform, enterprise-wide system designed to capture, link, trace, analyze and manage changes to information to ensure a project's compliance to specified requirements and standards. "DOORS helps solve the problem of creating and maintaining electronic records for FDA-regulated companies," said Gene Skrzypczyk, founder of SkripTek Partners, Inc. SkripTek works primarily with companies in the medical device and pharmaceutical industry to help them with their FDA- related validation documentation needs. Skrzypczyk was introduced to DOORS by one of his clients; now he recommends DOORS to his other customers. When a drug manufacturer decides to buy a software package for a chromatography machine, for example, it's not a simple matter. Companies must demonstrate compliance and traceability throughout the process. They must have an audit trail that details the purchase plan, the requirements for the system, the request for proposals, the vendors' responses, the validation plan for the system itself and the test results that prove the software meets the requirements. The process and record keeping becomes even more complicated when it involves building a medical device, manufacturing a drug or running clinical trials. "They have to document all of this with an emphasis on the traceability matrix. Typically, they will use Word and Excel documents, circulating sequential documents. Managing that from a practical standpoint is quite complicated," Skrzypczyk explained. "These companies understand requirements management, so they see the value of DOORS immediately. With DOORS, all the information is together in one location, with end-to-end traceability and a complete history of changes," he said. "The benefit is incredible. They can validate their systems more quickly, get the systems running more quickly and reduce overhead." The introduction of electronic signature capability in DOORS 6.0 SR1 provides even more advantages for FDA-regulated companies. Not only do these companies need to keep an extensive audit trail, they must verify the authenticity of the data and records with time-stamped signatures. "We need the ability to produce copies of old records. A lot of companies will keep records electronically and then print out a copy, sign that and kept that as a record," said Bernie Liebler, Director of Technology and Regulatory Affairs at AdvaMed (Advanced Medical Technology Association). AdvaMed is an industry group that represents more than 1,100 manufacturers of medical devices, diagnostic products and medical information systems. "But the FDA is unhappy about hybrid systems. You can't have paper and electronic systems," Liebler said. The electronic signature capability in DOORS 6.0 SR1 allows users to electronically sign baselines. DOORS baselines provide a time-stamped, unalterable historical record of all the information - including traceability links, user comments and changes made - that is stored in DOORS. "The electronic signature capability against baselines is a powerful new feature," said Paul Raymond, Vice President Product Management, Requirements Management Tools for Telelogic. "We are the only vendor that provides this capability. With DOORS, you can baseline at each stage in the process, sign it electronically, and preserve that record electronically. We support full compliance with the FDA regulations." Future releases of DOORS will expand the electronic signature capability even further, to offer customers greater flexibility with when and how they want to provide electronic signatures. "We're the experts in requirements management," Raymond said. "DOORS is a proven solution, used in mission- and life-critical projects with as many as 5 million requirements and 4 gigabytes of data. "Anyone can use DOORS' electronic signature capability to get formal sign-off, but no other industry puts so much emphasis on it," Raymond added. "DOORS' reliability, scalability and capabilities make it a perfect match for the strict demands of the pharmaceutical and medical device industry." DOORS is used by many of the industry's leading companies, including Abbott Labs, Bayer Diagnostics, Beckman Instruments, Bristol Myer Squibb, CVS, GE Medical, HP Medical, Kaiser Permanente, Merck Medco, Ortho Biotech, Pfizer, Siemens Medical, St. Jude Medical Inc. and Wyeth. About SkripTek SkripTek Partners, Inc. was founded to provide unique solutions for the manufacturing and laboratory workplaces. SkripTek partners with top- level organizations committed to providing first class products and services to improve productivity and/or regulatory compliance for laboratory and manufacturing operations. These products and services typically are related to enhancing data management, data collection and information dissemination. For more information, please visit www.skriptek.com. About PhRMA The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country's leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. The industry invested more than US$30 billion in 2001 in discovering and developing new medicines. PhRMA companies are leading the way in the search for new cures. For more information, please visit www.phrma.org. About AdvaMed The Advanced Medical Technology Association, AdvaMed, (formerly HIMA) is the largest medical technology association in the world. We represent more than 1,100 innovators and manufacturers of medical devices, diagnostic products and medical information systems. Our members manufacture 90 percent of the US$71 billion of health care technology purchased annually in the United States and more than 50 percent of the US$169 billion purchased around the world annually. For more information, please visit www.advamed.org. About Telelogic Founded in 1983, Telelogic® is the leading global provider of solutions for advanced systems and software development. The company's integrated best-in-class software tools, supported by professional services, enable companies to automate their entire development lifecycle, resulting in improved quality and predictability with reduced time-to-market and overall costs. To ensure interoperability with third-party tools, Telelogic's products are built on an open architecture and standardized languages. As an industry leader and technology visionary, Telelogic is actively involved in shaping the future of advanced systems and software development by participating in industry organizations like 3GPP, ETSI, INCOSE, ITU-T, MOST, OMG and others. Headquartered in Malmö, Sweden with U.S. headquarters in Irvine, California, Telelogic has more than 800 employees worldwide. Customers include Alcatel, BAE SYSTEMS, BMW, Boeing, DaimlerChrysler, Deutsche Bank, Ericsson, General Motors, Lockheed Martin, Motorola, NEC, Nokia, Philips, Siemens and Thales. For more information, please visit www.telelogic.com. ### Telelogic, Telelogic DOORS, Telelogic Tau and Telelogic DocExpress are the registered trademarks of Telelogic. Telelogic Synergy and ActiveCM are trademarks of Telelogic. All other trademarks are the properties of respective holders. Contact Americas/Asia: Contact Europe: Michael E. Donner, VP, Marketing & Ingemar Ljungdahl, Communications Chief Technology Officer Telelogic Americas Telelogic AB Phone: +1 (949) 885-2496 Phone: +46 40 650 00 00 E-mail: michael.donner@telelogic.com E-mail: ingemar.ljungdahl@telelogic.com ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.waymaker.net/bitonline/2002/12/18/20021218BIT00910/wkr0001.doc http://www.waymaker.net/bitonline/2002/12/18/20021218BIT00910/wkr0002.pdf