Telelogic DOORS® Extends Market Leadership Through Electronic Signature Software Integration With NuGenesis Technologies
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Telelogic, (Stockholm Exchange: TLOG), a leading global provider of solutions for advanced software and systems development, today announced that Telelogic DOORS has been integrated with NuGenesis® SDMS to provide customers an enhanced electronic signature capability. DOORS was acquired by Telelogic from Quality Systems & Software in August 2000 and was named the market leader for requirements management by the Standish Group in its December 2000 industry report.
With NuGenesis SDMS electronic signature capability at the document level, DOORS can now support the development of projects and systems in compliance with Food and Drug Administration (FDA) Title 21 - Code of Federal Regulations - Part 11 (21 CFR Part 11) regulations. Under these rules, companies producing controlled substances and devices for the medical/healthcare industry can now use electronic records and signatures in lieu of paper records and handwritten signatures for documentation, provided they comply with 21 CFR Part 11. The NuGenesis solution supports full compliance with 21 CFR Part 11.
"Integrating DOORS with the electronic signature solution from NuGenesis Technologies provides medical and healthcare customers with an extremely powerful requirements management solution," said Bill Philbin, senior vice president, global product organization at Telelogic. "When combined with the benefits of automation, synchronization and integration, electronic signature capability that is equivalent to a handwritten signature at a document level further strengthens DOORS' position as the industry's pre-eminent requirements management tool."
The patented NuGenesis Scientific Data Management System (SDMS) is designed for the collection, storage, retrieval and reuse of electronic information and is especially useful in the laboratory environment. NuGenesis SDMS automatically captures and catalogs both human-readable and machine-readable data from a variety of laboratory and business applications, and stores that data in a central repository. Once in the database, scientists easily access the data from any location via the Internet, and can then share their analyses and interpretations with colleagues across the enterprise.
"Offering the e-signature capabilities of NuGenesis SDMS with Telelogic DOORS will significantly streamline software software and systems development processes in the heavily regulated life sciences," says Bernie Prusaczyk, vice president business development and channels for NuGenesis Technologies. "Furthermore, by providing a fully automated, 100% paperless solution to software and systems engineers/developers, this partnership creates many new market opportunities for both companies to explore."
Advanced Electronic Records Capabilities
Medical and healthcare professionals can now manage their information on a secure database while maintaining access to information throughout the documents retention period. Tracking of changes to a document, such as author, date, time, and signatures, are captured and logged as part of the electronic record. The integrated capability of Telelogic DOORS and NuGenesis SDMS ties together a solution for electronic records management and compliance with the FDA's 21 CFR Part 11.
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