The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
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CI/CD makes modern software development quicker and easier. Dive into this in-depth guide to explore what CI/CD can do for your organization.What You Will Learn Discover topics such as: CI/CD fundamentals The benefits of CI/CD Differences between CI/CD and...
In the rapidly evolving threat landscape, secure software development is essential. DevOps teams must embed security throughout the development lifecycle to reduce risks, meet compliance requirements, and deliver trustworthy applications. As a leading DevSecOps...
In the high-stakes world of aerospace engineering, failure is not an option. Whether developing spacecraft, military drones, or next-generation commercial aircraft, aerospace manufacturers must prioritize safety, reliability, and performance. One proven method for...
Corrective and Preventive Action (CAPA) is a cornerstone of quality management in regulated industries. The CAPA process is essential not only for addressing current issues but also for proactively preventing future ones. It’s systematic, closed-loop, risk-based, and...