FARMINGDALE, NY (07-09-08): EtQ has announced the implementation of EtQ Reliance for Medical Device Software at CardioDx. CardioDx is developing a series of molecular tests for diagnosing cardiovascular disease that will enable physicians to make better-informed treatment decisions.
It was CardioDx's decision to move away from a decentralized Quality system and implement a software platform that would allow them to manage an enterprise Quality Management System (QMS), with the ability to integrate with their existing business systems and automate business processes.
EtQ has been able to provide a solution that is flexible enough to grow with CardioDx as they expand their operations, and grow their business. Using EtQ's robust set of modules such as Document Control, Training, and Corrective Action/Preventive Action, CardioDx will be able to automate their quality process, integrate quality to their operation, and collaborate across the enterprise while providing a level of flexibility to configure the software to meet their specific business needs.
"For CardioDx, EtQ is flexible enough to adapt and scale to their growing business, while maintaining the high level of compliance needed to meet the demand of the FDA," states Glenn McCarty, Chief Executive Officer at EtQ. EtQ is able to provide a solution that is flexible enough to match business process exactly, while maintaining compliance to FDA requirements, with enhanced security features, electronic signatures, audit trail tracking, and maintaining compliance to FDA initiatives.
Founded in 2004, CardioDx is a molecular diagnostics company located in Palo Alto, CA. CardioDx is developing clinically validated molecular diagnostics specifically for cardiovascular disease. Through novel molecular tools and informatics, the company's products and services empower physicians with more precise information and greater confidence for individual treatment decisions. CardioDx diagnostic tests will help cardiologists identify patients who will benefit most from advanced cardiovascular therapies, enabling them to deliver the right treatment to the right patient at the right time.
EtQ is the leading Enterprise Quality and Compliance Management Software for identifying, mitigating, and preventing high-risk events through integration, automation, and collaboration. EtQ uses best-in-class, integrated modules and enterprise application integration to manage and measure quality and compliance processes and execute organizational change. Key modules within the product include: Document Control, CAPA (Corrective and Preventive Action), Audit Software, Complaint Handling, Risk Management, Change Management, Employee Training, Project Management, Nonconforming Materials, Enterprise Reporting, and more than 20 additional compliance-oriented modules. With its world-class flexible workflow, collaborative platform, EtQ has developed a unique niche to support enterprises involved in various compliance management initiatives such as; cGxP (FDA), ISO 13485, ISO 9001:2008, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP, SQF and similar standards for compliance and regulatory management. EtQ has been providing compliance solutions to a variety of markets for over 15 years.
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