Software provides quality management for ECM software.
Press Release Summary:
Combining Livelink ECM platform from Open Text(TM) Corporation with knowledge of Life Sciences industry, Quality Management System module allows regulated businesses to rapidly deploy quality management system that meets FDA's stringent electronic record-keeping requirements. Livelink ECM - QMS integrates key processes required by regulated industries, including Corrective and Preventive Actions, Audits, Training, and Regulated Document Management into enterprise-level solution.
Original Press Release:
Stelex Announce QMS Module for Open Text's Livelink ECM
Quality Management System delivers unmatched out-of-the-box functionality
BENSALEM, Pa., Oct. 18 /-- Stelex-The Validation Group, Inc. (Stelex), the market leader in providing enterprise-wide compliance solutions to the regulated industries, today announced the Quality Management System (QMS) module for Livelink ECM from Open Text(TM) Corporation, the largest independent provider of Enterprise Content Management (ECM) software and solutions. QMS for Livelink ECM will be demonstrated at Open Text's North American user conference LiveLinkUp 2007, in Orlando, Florida.
This groundbreaking product brings together Open Text's powerful Livelink ECM platform with Stelex' deep knowledge of the Life Sciences industry and regulatory issues. The QMS module allows regulated businesses to rapidly deploy a quality management system that meets the FDA's most stringent electronic record-keeping requirements.
The QMS module gives regulated industries, including pharmaceutical, medical device, biotechnology, and diagnostic companies, a flexible and expandable solution to manage quality issues and initiatives. QMS provides a fully integrated solution that complies with the electronic records provisions of the U.S. Food and Drug Administration's (FDA) 21 CFR Part 11, while addressing the needs for Pharmaceutical Best Practice (21 CFR 210 and 211), Biological Best Practice (21 CFR 600-680) and Medical Device Best Practice (21 CFR 820). The system is also configurable to meet the Quality System requirements of ISO9000, EPA QA/G-1, and similar standards governing regulated industries.
Livelink ECM - QMS integrates the key processes required by regulated industries, including Corrective and Preventive Actions (CAPA), Audits, Training and Regulated Document Management into an enterprise-level solution. Documents that are needed for audits, CAPA, training, etc. can be created, reviewed, approved, edited and maintained within the Quality Management System repository. Using the Livelink ECM platform, can assist in savings in hardware, software and maintenance costs throughout the system lifecycle.
"This highly configurable product provides out-of-the-box functionality that is unmatched in the industry," said Jim Day, Open Text Partner Manager at Stelex.
LiveLinkUp 2007
Open Text's LiveLinkUp 2007 Orlando Conference brings together customers, partners and industry leaders to review the latest in ECM strategies and technologies. LiveLinkUp 2007 is being held this year on October 23 - 25 at the JW Marriott Orlando Grande Lakes, Orlando, Florida. To see a live demonstration, visit Stelex in the Table Top Booth area. For more information, go to: http://livelinkup.opentext.com/orlando/2007/
About Stelex
Stelex is a consulting firm providing enterprise-wide compliance solutions to regulated industries in the Pharmaceutical, Medical Device, Diagnostic and Biotechnology sectors for over 20 years. The firm delivers a comprehensive suite of Validation, Technology, Regulatory and Business solutions. Learn more about Stelex at http://www.stelex.com/.
Stelex is a subsidiary of Vital Signs, Inc. (NASDAQ:VITL). Vital Signs, Inc. and its subsidiaries design, manufacture and market primarily single-use medical products for the anesthesia, respiratory/critical care, interventional cardiology/radiology and sleep/ventilation markets, achieving the number one market share position in five of its major product categories. Vital Signs is ISO 9001 certified and has CE Mark approval for its products.
CONTACT: Jim Day of Stelex, +1-215-352-1173, jday@stelex.com; or Michele Stevenson of Open Text, mstevens@opentext.com
Web site: http://www.stelex.com/
http://livelinkup.opentext.com/orlando/2007
