FARMINGDALE, NY (01-03-08): EtQ has announced the implementation of EtQ Quality Management System at Amedica Corporation; an emerging orthopedic implant company focused on using its silicon nitride ceramic technologies to develop and commercialize a broad range of innovative, high-performance spine and joint implants for the growing orthopedic device market.
Using EtQ's robust set of integrated modules such as Calibration & Maintenance, Document Control and Training, Amedica 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.
EtQ has been able to provide a solution that is flexible enough to grow with Amedica as they expand their operations, and grow their business. "For Amedica, 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 Glen McCarty, Chief Executive Officer of EtQ.
EtQ is able to provide a solution that is flexible enough to match business processes exactly, while maintaining compliance to FDA requirements; with enhanced security features, electronic signatures, audit trail tracking and being able to maintaining compliance to FDA initiatives.
Amedica Corporation develops, manufactures, and hopes to one day commercialize joint and spine implants made of silicon nitride ceramic, a material thought to be more durable, resistant, and patient-compatible than that of traditional implants. Amedica's lead product candidates are spinal implants branded as Valeo and intended to restore and maintain vertebrae alignment in the neck and lower back. The company expects to launch these products by mid-2008, pending US Food and Drug Administration approval. It also plans to launch a clinical trial of its Infinia family of ceramic hip and knee implants.
Amedica will use IPO proceeds to finance the development and commercialization of these lead products. It also wants to build its sales, marketing, and distribution capabilities; establish commercial manufacturing facilities; and fund research for future products.
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.
EtQ is a trademark of EtQ Management Consultants, Inc. All other product names and company names are trademarks or registered trademarks of their respective owners.