Product News

An integrated quality and US FDA– compliance management system is preconfigured to address medical device industry needs specifically and to exceed the GMP and 21 CFR Part 11 requirements for software. The modular approach of the EtQ Medical Device (GMP) FDA-management software solution maximises flexibility and automation, with connection functions closing gaps between production systems and the enterprise’s quality system. Modules for nonconforming material and complaint handling connect to enterprise resource planning and customer relations management systems to automate the creation and assignment of event reports, and then production systems are automatically updated throughout the event resolution process. The software is designed to minimise the number of corrective and preventive actions through the use of an advanced filtering model that includes root cause analysis. An automated validation module can shorten the duration of the validation process from weeks to minutes.
EtQ UK
Stourbridge, UK +44 845 519 2025
www.etquk.com