Quality Management System delivers unmatched out-of-the-box functionality
BENSALEM, Pa., Oct. 18 /PRNewswire-FirstCall/ -- 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
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