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Open Text Introduces New Collaborative Solution To Speed Product Development For The Pharmaceutical Industry
Livelink Certification Addresses FDA Electronic Record and Electronic Signature Regulations
Waterloo, ON - 2001-09-11 - Open Text™ Corporation (Nasdaq: OTEX, TSE: OTC), a worldwide leader in delivering collaborative commerce solutions, today announced the availability of Livelink Certification™. Livelink Certification is designed specifically to meet the requirements of the United States Food and Drug Administration's (FDA) 21 CFR Part 11 regulations governing electronic records and electronic signatures. This new solution builds on Livelink®'s collaborative functionality to offer a unique and industry-specific solution for FDA-regulated companies, such as those in the pharmaceutical and related life-science industries.
Livelink Certification adds to the already powerful collaborative features of Livelink helping Open Text customers, such as Pfizer, Bristol-Myers Squibb and Zimmer Inc., gain greater efficiencies.
Livelink Certification is designed to meet the pharmaceutical industries' need to manage an explosion of information while accelerating drug discovery and development. As the use of electronic format for presentation of records and documentation to support FDA applications and other submissions increased, the FDA recognized the need to provide guidelines to ensure the authenticity, date of creation, and appropriate internal approval of these submissions. The 21 CFR Part 11 regulations provide guidelines for the pharmaceutical industry to collaborate electronically with the FDA.
"Open Text is the first company to provide a pharmaceutical solution that directly addresses the FDA's electronic records and signature requirements,” said Martin Sumner-Smith, Open Text's vice president of pharmaceutical solutions. "Livelink Certification is fully integrated as part of the secure, reliable Livelink platform, unlike other offerings that rely on third parties to add functionality, adding complexity and uncertainty to these mission-critical applications."
Livelink Certification provides robust tools for administering electronic signing rights, including the ability to delegate certain users as signature administrators. Livelink Certification also enhances workflow by adding the ability to initiate a workflow from a document and by adding a new signature workflow step. In addition, this solution provides enhanced audit features including the ability to track unauthorized access attempts, inactive user sessions, and document signing events.
"Companies purchasing document and records management software increasingly demand digital signature compliance, such as 21 CFR Part 11 from the FDA and the new Environmental Protection Agency's regulations. In fact, within the pharmaceutical industry, software that cannot be deployed in a Part 11 compliant manner will be rejected in the first round cut," says Richard Lysakowski, executive director and chief science and technology officer, CENSA, one of the world's leading industry associations dedicated to driving advanced electronic record-keeping systems and collaborative technologies. "The pharmaceutical industry clearly prefers a single, integrated and supported product offering. By meeting the rigorous requirements of the FDA's Part 11 regulation, Open Text has demonstrated its commitment to life science and related vertical markets."
Livelink Certification adds to the already powerful collaborative features of Livelink helping Open Text customers, such as Pfizer, Bristol-Myers Squibb and Zimmer Inc., gain greater efficiencies.
Livelink Certification is designed to meet the pharmaceutical industries' need to manage an explosion of information while accelerating drug discovery and development. As the use of electronic format for presentation of records and documentation to support FDA applications and other submissions increased, the FDA recognized the need to provide guidelines to ensure the authenticity, date of creation, and appropriate internal approval of these submissions. The 21 CFR Part 11 regulations provide guidelines for the pharmaceutical industry to collaborate electronically with the FDA.
"Open Text is the first company to provide a pharmaceutical solution that directly addresses the FDA's electronic records and signature requirements,” said Martin Sumner-Smith, Open Text's vice president of pharmaceutical solutions. "Livelink Certification is fully integrated as part of the secure, reliable Livelink platform, unlike other offerings that rely on third parties to add functionality, adding complexity and uncertainty to these mission-critical applications."
Livelink Certification provides robust tools for administering electronic signing rights, including the ability to delegate certain users as signature administrators. Livelink Certification also enhances workflow by adding the ability to initiate a workflow from a document and by adding a new signature workflow step. In addition, this solution provides enhanced audit features including the ability to track unauthorized access attempts, inactive user sessions, and document signing events.
"Companies purchasing document and records management software increasingly demand digital signature compliance, such as 21 CFR Part 11 from the FDA and the new Environmental Protection Agency's regulations. In fact, within the pharmaceutical industry, software that cannot be deployed in a Part 11 compliant manner will be rejected in the first round cut," says Richard Lysakowski, executive director and chief science and technology officer, CENSA, one of the world's leading industry associations dedicated to driving advanced electronic record-keeping systems and collaborative technologies. "The pharmaceutical industry clearly prefers a single, integrated and supported product offering. By meeting the rigorous requirements of the FDA's Part 11 regulation, Open Text has demonstrated its commitment to life science and related vertical markets."
About Livelink
Livelink is a highly collaborative commerce and knowledge management application. Its richly-featured enterprise services include virtual team collaboration, business process automation, enterprise group scheduling and information retrieval services, all tightly integrated into a solution that is easily customized and extended. Livelink is essential to the effective management and development of communities of interest that span organizations and industries. For everything from the creation of complex e-community relationships to the automation of simple e-business processes, Livelink delivers true dynamic collaboration between individuals, organizations, and large trading communities. Livelink servers are fully Web-based and open-architected to ensure rapid deployment and easy access to its full functionality through a standard Web browser. For more information, visit www.opentext.com/livelink/.
About Open Text
Open Text provides collaborative commerce solutions for e-business that enable users to extend and build CRM, SCM and ERP applications and allow them to work together within and across organizations. Open Text has pioneered the development of innovative intranet, extranet and e-business applications. Since creating one of the first search engines to index the World Wide Web, the Company has remained at the forefront of Internet-based technologies. Its solution family called Livelink enables individuals, teams, organizations, and global trading communities to collaborate on e-business applications that facilitate e-commerce and other transactions among Global 2000 organizations. For more information, visit www.opentext.com.
Trademark
Copyright (C) 2001 by Open Text Corporation. Livelink and Open Text are trademarks or registered trademarks of Open Text Corporation. This list is not exhaustive. Other product and company names herein may be trademarks of their respective owners.
Release Disclaimer
This news release may contain forward-looking statements relating to the deployment of Livelink by customers, and future performance of Open Text Corporation. Forward-looking statements 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 final prospectus for the Company's initial public offering of common stock in January 1996, Form 10-K for the years ended June 30, 1998, June 30, 1999, and June 30, 2000, and Form 10-Q for the quarters ended September 30, 2000, December 31, 2000 and March 31, 2001. Forward-looking statements 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
