FARMINGDALE, NY (09-04-07): EtQ has announced the implementation of EtQ FDA Compliance Management System at EraGen Biosciences, Inc., a biotechnology firm that develops nucleic databases and other tools to help drug and diagnostics developers better use genomic information to streamline R&D processes.
EraGen is a rapidly growing company, and develop technologies used in many large-scale pharmaceutical and medical device companies. They needed a solution that would help them not only manage records and track CAPAs and training, but also allow them to scale with their growing operations.
"Using EtQ, EraGen will be able to streamline and configure their compliance system to meet their specific business needs," says Morgan Palmer, Chief Technology Officer at EtQ."Furthermore, EtQ's robust utilities and integrated set of modules enable them to automate their business processes while maintaining compliance to both ISO 13485 and FDA requirements." EtQ has been able to provide a solution that is flexible enough to grow with EraGen as they expand their operations, and grow their business.
EraGen is Biotechnology Company serving essentially all of the nucleic acid molecular diagnostic needs in the global healthcare market. They design, develop, manufacture and market the next generation of automated genetic testing products for early, accurate diagnosis of critical diseases. The company is developing nucleic databases and other tools to help drug and diagnostics developers better use genomic information to streamline their R&D processes. Molecular clinical diagnostics, bioterrorism threat detection, and personalized medicine are other markets the company is pursuing.
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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