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Open Text: Life Sciences Companies Quickly Turning To ECM Software to Manage Compliance
More Than 100 Life Sciences Companies Now Using Open Text's Livelink
Chicago, IL. - 2005-02-01 - Open Text™ Corporation (Nasdaq: OTEX, TSX: OTC), the world's largest provider of Enterprise Content Management (ECM) software, said today it continues to see strong demand for its ECM solutions among pharmaceutical and biotechnology companies, with more than 100 life sciences companies now using its Livelink software. Life sciences firms are turning to ECM to help them manage the complex processes and enormous volumes of information needed to gain regulatory approvals for new drugs and medical devices.
In the last year, about 43 life sciences companies adopted or expanded their Livelink solutions. These companies include BioMarin Pharmaceuticals, CancerVax, Anadys Pharmaceuticals, Cell Therapeutics, Pharmion, Tercica Medica, Amylin, La Jolla Pharmaceuticals, Santarus and XOMA, Ltd. The companies are among a long list of life sciences companies utilizing Livelink, including Roche, Genzyme, bioMérieux, Inc., Chiron and Celgene.
What’s driving the need for ECM in life sciences? The particularly demanding compliance requirements in this sector are the main factor. The worldwide life sciences industry is one of the most heavily regulated and data intensive markets. Product development can take decades and involve the collaboration of many hundreds of people in multiple organizations around the globe. Millions of pages of documentation and data must be carefully managed in accordance with strict guidelines set forth by government regulators in multiple countries, including the U.S. Food and Drug Administration (FDA).
Companies use Open Text’s Livelink to manage documents and other content at all stages—from target selection, research, clinical development and manufacturing, through to market introduction and sales. Information is managed in accordance with regulations such as the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11, as well as emerging industry standards such as Secure Access for Everyone (SAFE), an industry initiative to establish an open, global standard for secure and legally enforceable digitally signed documents exchanged between companies and with their regulators. Open Text’s life sciences industry solutions include:
•Livelink for Clinicals -- Designed to manage the capture and review of all trial-related information throughout the setup, conduct and review of clinical trials. It provides a robust repository that supports both electronic and paper formats. Support is provided for several industry leading scanning solutions, as well as electronic data capture and e-mail.
•Livelink for Collaborative Submissions -- A comprehensive, collaborative environment for the authoring, review, approval, assembly, export, and long-term management of all regulatory documents and submissions. It combines a full document management feature set, rich metadata support, huge scalability, and a wide range of secure, collaborative business-process tools.
•Livelink for Regulated Documents -- A complete solution to securely manage key documents throughout a controlled lifecycle in compliance with relevant regulatory requirements such as CFR 21 Part 11.
"The life sciences industry is extremely competitive, so building efficiencies into the regulatory approval process is very important for customers," said Dr. Martin Sumner Smith, Vice President of Pharmaceutical and Life Sciences Solutions at Open Text. "ECM software does that by helping customers reduce the risk of errors, improve business process execution and ensure that documentation supporting the development of life-saving drugs and medical devices is both accurate and accessible to appropriate staff whenever they need it."
In the last year, about 43 life sciences companies adopted or expanded their Livelink solutions. These companies include BioMarin Pharmaceuticals, CancerVax, Anadys Pharmaceuticals, Cell Therapeutics, Pharmion, Tercica Medica, Amylin, La Jolla Pharmaceuticals, Santarus and XOMA, Ltd. The companies are among a long list of life sciences companies utilizing Livelink, including Roche, Genzyme, bioMérieux, Inc., Chiron and Celgene.
What’s driving the need for ECM in life sciences? The particularly demanding compliance requirements in this sector are the main factor. The worldwide life sciences industry is one of the most heavily regulated and data intensive markets. Product development can take decades and involve the collaboration of many hundreds of people in multiple organizations around the globe. Millions of pages of documentation and data must be carefully managed in accordance with strict guidelines set forth by government regulators in multiple countries, including the U.S. Food and Drug Administration (FDA).
Companies use Open Text’s Livelink to manage documents and other content at all stages—from target selection, research, clinical development and manufacturing, through to market introduction and sales. Information is managed in accordance with regulations such as the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11, as well as emerging industry standards such as Secure Access for Everyone (SAFE), an industry initiative to establish an open, global standard for secure and legally enforceable digitally signed documents exchanged between companies and with their regulators. Open Text’s life sciences industry solutions include:
•Livelink for Clinicals -- Designed to manage the capture and review of all trial-related information throughout the setup, conduct and review of clinical trials. It provides a robust repository that supports both electronic and paper formats. Support is provided for several industry leading scanning solutions, as well as electronic data capture and e-mail.
•Livelink for Collaborative Submissions -- A comprehensive, collaborative environment for the authoring, review, approval, assembly, export, and long-term management of all regulatory documents and submissions. It combines a full document management feature set, rich metadata support, huge scalability, and a wide range of secure, collaborative business-process tools.
•Livelink for Regulated Documents -- A complete solution to securely manage key documents throughout a controlled lifecycle in compliance with relevant regulatory requirements such as CFR 21 Part 11.
"The life sciences industry is extremely competitive, so building efficiencies into the regulatory approval process is very important for customers," said Dr. Martin Sumner Smith, Vice President of Pharmaceutical and Life Sciences Solutions at Open Text. "ECM software does that by helping customers reduce the risk of errors, improve business process execution and ensure that documentation supporting the development of life-saving drugs and medical devices is both accurate and accessible to appropriate staff whenever they need it."
About Open Text
Open Text™ is the market leader in providing Enterprise Content Management (ECM) solutions that bring together people, processes and information in global organizations. Throughout its history, Open Text has matched its tradition of innovation with a track record of financial strength and growth. Today, the company supports more than 17 million seats across 13,000 deployments in 67 countries and 12 languages worldwide. For more information on Open Text, go to: www.opentext.com
Trademark
Copyright © 2005 by Open Text Corporation. LIVELINK and OPEN TEXT are trademarks or registered trademarks of Open Text Corporation in the United States of America, Canada, the European Union and/or other countries. This list of trademarks is not exhaustive. Other trademarks, registered trademarks, product names, company names, brands and service names mentioned herein are property of Open Text Corporation or other respective owners.
Release Disclaimer
This news release may contain forward-looking statements relating to the success of any of the Company’s strategic initiatives, the Company’s growth and profitability prospects, the benefits of the Company’s products to be realized by customers, the Company’s position in the market and future opportunities therein, the deployment of Livelink and our other products by customers, and future performance of Open Text Corporation. Forward-looking statements may also include, without limitation, any statement relating to future events, conditions or circumstances. Forward-looking statements in this release are not promises or guarantees and are subject to certain risks and uncertainties, and actual results may differ materially. These risks and uncertainties include, among others, risks involved in the completion and integration of acquisitions, the possibility of technical, logistical or planning issues in connection with deployments, the continuous commitment of the Company's customers and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Form 10-K for the year ended June 30, 2004. You should not place undue reliance upon any such forward-looking statements, which are based on management's beliefs and opinions at the time the statements are made, and the Company does not undertake any obligations to update forward-looking statements should circumstances or management's beliefs or opinions change.
For more information, please contact
Margaret E. Dobbin
Director, Industry Analyst Relations
Open Text Corporation
+1-519-888-7111 ext.2410
mdobbin@opentext.com
Director, Industry Analyst Relations
Open Text Corporation
+1-519-888-7111 ext.2410
mdobbin@opentext.com
