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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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Integrated Quality Management Software 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 GMP and 21 CFR Part 11 software requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. These modules are tightly integrated to deliver a best-in-class FDA Management Software solution.
Connected to the Production Systems
EtQ Connectors close the gap between production systems and the quality system. Modules like nonconforming materials and Complaint handling connect to ERP and CRM systems to fully automate the creation and assignment of events. Production systems can then be automatically updated throughout the event resolution process. For example, to trigger the release of product based on the MRB disposition; or update the complaint status based on the CAPA investigation results.
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Advanced Filtering of Events
EtQ's unique FDA Compliance Management Software System is designed to minimize the number of CAPAs using an advanced filtering model:
Closed-Loop
The EtQ Medical Device (GMP) FDA Compliance Software System is pre-configured to initiate various post-CAPA processes, including electronic distribution of CAPA results, Change Management, and Employee Training.
eValidation
EtQ offers an automated validation module that will shorten the validation process from weeks to minutes. EtQ's unique eValidator™ comes preloaded OQs and PQs for all the pre-configured modules.
Electronic Submissions to the FDA (eMDR)
EtQ Reliance eMDR Submission Tool enables Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to the Food and Drug Administration (FDA). This methodology allows companies to electronically automate the quality process for medical device, and comply with quality and compliance standards, including those of the FDA.
BROCHURES
EtQ Medical Device
Available Modules
EtQ Reliance
WHITE PAPERS
Managing Your Risk Has its Rewards
Beyond CAPA: Using Risk Assessment to Streamline your Quality System
PRODUCT PAPER
EtQ Integration Management
EtQ's Integration APIs are able to provide an enterprise quality management solution that integrates information silos, making timely coordination and communication easy to achieve and removing any information gatekeepers. This focused integration of information silos greatly improves productivity across the enterprise, and makes crucial data immediately available to the resources that need it, when they need it.
CASE STUDIES
FUJIJILM
FUJIFILM Manufacturing U.S.A., Inc. implemented EtQ Reliance in 2006, to help unify its sites and consolidate the company's quality and environmental processes. As Fujifilm moves forward, they plan to expand EtQ Reliance to cover its process safety management and FDA regulations. FUJIFILM Manufacturing, U.S.A., Inc. has utilized the robust features and modules of EtQ Reliance to coordinate compliance efforts across multiple sites, combine crucial processes for quality and environmental management, and expand the quality and compliance system for the long term.
Categories this company is listed under in the North American Suppliers Directory:
- Manufacturing Equipment and Software: Software: Design software (177 companies)
- Manufacturing Equipment and Software: Software: Manufacturing software (262 companies)
- Manufacturing Equipment and Software: Software: Regulatory software (137 companies)
- R&D, Design, and Business Services: Software development/Validation (236 companies)
