FDA Warning Letter: What It Is, Common Reasons, and How to Respond Properly An FDA Warning Letter is an official alert indicating that a company has violated significant regulations that could affect the […]
Read MoreWhat is a VPN? A VPN (Virtual Private Network) is a digital security service that allows users to access the internet as if they were connected to a private network. In simple terms, […]
Read MoreThe Importance of Change Control and Testing Before Software Updates In an era of rapid technological innovations and increasing cyber threats, efficient change management for software becomes crucial. A recent case that exemplifies […]
Read MoreEm 2011 a agência reguladora americana FDA (Food and Drugs Administration) lançou o programa Case for Quality com o objetivo de identificar as práticas adotadas por fabricantes de equipamentos médicos para atender as […]
Read MoreNos últimos anos as diversas normativas do Sistema de Gestão de Qualidade (SGQ), desde normas generalistas como a ISO 9001:2015 até normas especificas como a RDC 301 de 21 de agosto de 2019, […]
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