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ETQ
399 Conklin St., Ste. 208
Farmingdale, NY 11735
Tel: 516/293-0949
Fax: 516/293-0784
Web: http://www.etq.com/medicaldevice
E-mail: info@etq.com
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| EtQ Releases Enhanced Print to PDF Features into its Quality Management System | EtQ's Risk Assessment Module Incorporates Risk to the Quality System |
EtQ Medical Device (GMP) is an integrated quality and FDA compliance management system that has been pre-configured to specifically address the needs of the Medical Device Industry, and exceed 21 CFR Part 11 and GMP requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. The EtQ Medical Device (GMP) FDA Compliance Software System initiates various post-CAPA processes, including electronic distribution of CAPA results, Change Management, and Employee Training. Key modules include: Risk Assessment, CAPA, Document Control, Centralized Reporting, Nonconforming Materials, Audits, Complaint Handling (with eMDR Submission), Meetings, Planned Deviation, Change Management, Quality Records, Calibration & Maintenance, and more!
In the highly competitive Medical Device market, only the most innovative and cost-effective products will survive. Success in this industry requires adherence to applicable FDA regulations, and may also involve meeting ISO standard requirements. Device Manufacturers are challenged with maintaining Quality Management systems that can adapt to the changing market needs, provide tools to shorten product development lifecycles, manage the supply chain, and are compliant with a wide range of regulatory requirements. Having an FDA Compliance Software system to maintain compliance to the variety of regulatory requirements, and adapting to business processes is very important to the medical device industry.
As more companies rely on Contract Manufacturers to bring their medical device products to market, it is important that the systems implemented allow for increased visibility downstream. EtQ's FDA Compliance Software provides integration at multiple levels of the process, allowing contract manufacturers to take part in the overall medical device industry, without direct access to the main system.
EtQ's FDA Compliance Software is designed specifically for the medical device industry, and our staff has developed the test scripts necessary to ease system validation. Because EtQ's FDA Compliance Software is usable right out of the box, and configurations are executed at the server level, the need to extensive validation across the enterprise is less than comparative Quality and FDA Compliance Management Software systems in the market.
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EtQ is the leading Enterprise Quality and FDA 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.
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