Intellect has been helping organizations meet their compliance and quality needs for over 19 years. Ludovic flahaut commercial quality manager microport. Etq updates flagship quality management system industry. 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. Etq updates flagship quality management system industry today. Quality management software market segmentation, future. Life sciences regulated industries, medical devices manufacturers, etc. Qad qms cebos, etq reliance including evalidator, etq fwe it service management. Excellent validation and statistical skills that provides stability and compliance to the processes. As a leader, i am thrilled by the four fascinating daily opportunities that benefit patients.
Qms software recommendation us based, hemp iso 9000, iso 9001, and iso 9004 quality management systems standards. For example, companies making mediumrisk class ii or highrisk devices class iii devices will require a different qms implementation than companies making lowrisk, nonsterile, nonmeasuring, nonreusable. Etq is the leading provider of quality, ehs and compliance management software, trusted by the worlds strongest brands. Medical device manufacturers are faced with a wide range of quality and compliance challenges. 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. 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. What is a medical device quality management system qms. Etq is the leading quality, ehs and compliance management software provider for identifying, mitigating and preventing highrisk events through integration, automation and collaboration. Capa problems continue to bug medical device manufacturers as fda inspections increase. May 08, 2020 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.
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. To earn your iso 485 certification, youll need a documented quality management system qms that complies with the standard and all applicable regulatory requirements. Deployed to lead and implement quality management solution qms such as excellence through quality etq reliance webbased system inout of singapore to customers site i. Feb 22, 2011 qms software recommendation us based, hemp iso 9000, iso 9001, and iso 9004 quality management systems standards. Medical device manufacturing quality and compliance.
Most medical devices will require some form of a qms. 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. 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. 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. Connectwise, sysaid, office 365, bmc remedyforce software lifecycle.
Latest version of etq reliance qms software brings more. Etqs unique modular approach provides unparalleled flexibility and automation. Enterprise quality management software blog medical devices. 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. For medical devices which incorporate software or standalone software, the iec 62304 also demands a qms and recommends an iso 485. Isidoro has a strong background on pharmaceutical and medical devices quality systems. See the list of the best risk management software for businesses in south africa. Apr 15, 2020 compliance management, medical devices, qms software why fda compliance needs a defined capa process. 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. Gregory pierre schaeffer associate quality assurance. Compliance management, medical devices, qms software why fda compliance needs a defined capa process.
Representative of company with cofepris and responsible to perform any activity required for health officer in nom059. 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. Aside from the documents you will need for your individual jurisdiction, iso requires you to document elements like. 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. Jun, 2018 most medical devices will require some form of a qms. Qms for medical device, quality management software medical. Etq the best in class compliance platform designed specifically for qms, ehs, risk, gmp and iso requirements. When it comes to iso certifications, one thing companies can count on is a mountain of documentation. 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. Quality management software qms software etq reliance.
Ludovic flahaut commercial quality manager microport crm. About etq is the leading provider of quality, ehs and compliance management software, trusted by the worlds strongest brands. 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. Risk analysis of qms software validating software we use for qms. Qms for medical devices industryleading solutions for medical device quality and compliance management. The validity of the quality management system will be examined by external auditors usually notified bodies and internal audits. 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. Isidoro flores rodriguez sr quality assurance manager. 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. Etq provides a compliance management platform that enables organizations to implement compliance processes, create new processes and automate and control their. See the list of the best quality management software for businesses in south africa. Ajay b pazhayattil pharmaceutical management consultant. Qms for medical device, quality management software.
1550 126 881 1530 375 1401 1135 946 130 596 1592 98 172 394 1565 1049 1115 63 160 461 420 526 126 1069 225 615 531 921 497 134 1206 593 1244 416 1308