FARMINGDALE, NY (07-23-08): EtQ has announced the implementation of EtQ Reliance for Medical Devices at Stereotaxis-designers and manufacturers, of an advanced cardiology instrument control system for use in a hospital's interventional surgical suite, for the treatment of arrhythmias and coronary artery disease.
Stereotaxis recognized the need for a strong Quality Management System (QMS) to help them maintain a high level of quality and compliance. Using EtQ's robust set of modules such as Document Control, Complaint Handling, Change Control, and Corrective/Preventive Action, Stereotaxis will be able to automate their business process and collaborate across the enterprise while providing a high level of flexibility to configure the software to meet their business needs.
Of particular interest to Stereotaxis, was the ability for a QMS to integrate with their existing Customer Relationship Management (CRM) system, Salesforce.com, to handle customer complaints. EtQ is able to provide the high level of flexibility that Stereotaxis needs and, acting as a Web-service to Salesforce.com, allows customer complaints to be integrated and in turn, answered more quickly and accurately.
EtQ is also able to provide a solution that is flexible enough to match their business processes exactly, while maintaining compliance to FDA requirements. Enhanced security features, electronic signatures, audit trail tracking, and more have enabled Stereotaxis to use EtQ to maintain compliance to FDA initiatives.
"Using EtQ, Stereotaxis will be able to streamline and configure the system to improve business processes while meeting the demands of the FDA," stated Morgan Palmer, Chief Technology Officer at EtQ. "EtQ's flexible QMS will allow Stereotaxis to become more efficient in their operations, reduce quality issues, and make compliance a competitive advantage for their brand."
Stereotaxis, Inc. designs, manufactures, and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite (cath lab), for the treatment of arrhythmias and coronary artery disease. Stereotaxis' system allows physicians to navigate catheters, guidewires, and other delivery devices, both its own and those the company is co-developing with partners, through the blood vessels and chambers of the heart to treatment sites in order to effect treatment. Stereotaxis' system's components consist of Niobe magnetic navigation system, Navigant advanced user interface, Cardiodrive catheter advancement system, and disposable interventional devices.
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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