Life sciences regulated industries, medical devices manufacturers, etc. Ludovic flahaut commercial quality manager microport crm. Excellent validation and statistical skills that provides stability and compliance to the processes. More than 550 global companies, spanning industries including electronics, heavy industry, food and beverage, and medical devices, use etq to secure positive brand reputations, deliver higher levels of customer loyalty and enhance profitability. Apr 15, 2020 compliance management, medical devices, qms software why fda compliance needs a defined capa process. More than 500 global companies, spanning industries including automotive, biotech, food and beverage, manufacturing and medical devices, use etq to secure positive brand reputations, deliver higher levels. See the list of the best quality management software for businesses in south africa. Morgan joined etq to create the companys first software application and is now responsible for reliance, etq s flagship product for quality, environmental and safety management. Feb 22, 2011 qms software recommendation us based, hemp iso 9000, iso 9001, and iso 9004 quality management systems standards. For medical devices which incorporate software or standalone software, the iec 62304 also demands a qms and recommends an iso 485. What is a medical device quality management system qms.
Owner of the quality management system, its processes and quality objectives for their design, maintenance, monitoring and continuous improvement regarding quality assurance and quality control warehouse health officer. Etq the best in class compliance platform designed specifically for qms, ehs, risk, gmp and iso requirements. Isidoro flores rodriguez sr quality assurance manager. Etq provides a compliance management platform that enables organizations to implement compliance processes, create new processes and automate and control their. Qms software recommendation us based, hemp iso 9000, iso 9001, and iso 9004 quality management systems standards. More than 500 global companies, spanning industries including automotive, biotech, food and beverage, manufacturing and medical devices, use etq to secure positive brand reputations, deliver higher levels of customer loyalty and enhance profitability. Qms for medical devices industryleading solutions for medical device quality and compliance management. Managing industry best practices to drive product innovation and patient safety assurx medical device manufacturing quality management software qms is designed to balance the complexity of global quality management and regulatory requirements while maintaining a high level of flexibility to adapt to continual industry and operational changes. Etq for medical devices integrated quality system etq medical device is an integrated quality and compliance management system that has been preconfigured to specifically address the needs of the medical device industry, and exceed 21 cfr part 11 requirements. Connectwise, sysaid, office 365, bmc remedyforce software lifecycle. Gregory pierre schaeffer associate quality assurance. Etq has developed a leading quality management software solution that provides a holistic and scalable solution for automating processes, integrating business systems, and fostering collaboration and continuous improvement.
Most medical devices will require some form of a qms. Etq is the leading provider of quality, ehs and compliance management software, trusted by the worlds strongest brands. The pharmaceutical industry is very dynamic and exciting. Compliance management, medical devices, qms software why fda compliance needs a defined capa process. May 08, 2020 etq is the leading provider of quality, ehs and compliance management software, trusted by the worlds strongest brands. Etq is the leading provider of quality, ehs and compliance management software, trusted by the worlds strongest brands, like kimberlyclark, novartis, herman miller and chobani. The validity of the quality management system will be examined by external auditors usually notified bodies and internal audits. Etq updates flagship quality management system industry today. Ajay b pazhayattil pharmaceutical management consultant. Medical device manufacturing quality and compliance. Ludovic flahaut commercial quality manager microport. Greenlight guru is the only electronic quality management software eqms designed by medical device professionals specifically to meet the unique needs of medical device companies. Aside from the documents you will need for your individual jurisdiction, iso requires you to document elements like.
Etq is the leading quality, ehs and compliance management software provider for identifying, mitigating and preventing highrisk events through integration, automation and collaboration. Carolina beverage had two specific criteria in mind when looking for a software vendor to meet their needs the software had to be user friendly and a comprehensive solution for all document management processes. Enterprise quality management software blog medical devices. About etq is the leading provider of quality, ehs and compliance management software, trusted by the worlds strongest brands. Intellect has been helping organizations meet their compliance and quality needs for over 19 years. Risk analysis of qms software validating software we use for qms. Its especially true for certifying to iso 485 for medical device quality management, as medical device manufacturers must provide extensive documentation as evidence of the safety of their productsand the effectiveness of their quality processes. Quality management software qms solutions are accessible in the market as they offer a horde of functionalities, including complaint treatment. Medical device manufacturers are faced with a wide range of quality and compliance challenges. As etq s chief technology officer, morgan continues to drive the innovation and strategy that make etq the leading provider in the markets it serves. Representative of company with cofepris and responsible to perform any activity required for health officer in nom059. Etqs unique modular approach provides unparalleled flexibility and automation.
Latest version of etq reliance qms software brings more. To earn your iso 485 certification, youll need a documented quality management system qms that complies with the standard and all applicable regulatory requirements. More than 550 global companies, spanning industries including electronics, heavy industry, food and beverage and medical devices, use etq to secure positive brand reputations, deliver higher levels of customer loyalty and. Quality management software market segmentation, future. Qad qms cebos, etq reliance including evalidator, etq fwe it service management. Qms for medical device, quality management software. Qms for medical device, quality management software medical. Quality management software qms solutions are accessible in the market as they offer a horde of functionalities, including complaint treatment nonconformance, calibration, document control, and. Intellects eqms is a powerful, centralized, and integrated solution to manage your quality needs today and tomorrow.
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