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.
We invite you to download our paper on the topic of 483 Observations.
Access governance is vital for ensuring data is safe and secure. In this eBook, we will explore how to maintain compliance with security regulations for IT teams utilizing Atlassian tools.What You Will Learn We will explore: Why identity governance matters in...
One of the largest causes of inefficiency across industries is disconnected systems. In the automotive industry, software teams need to communicate with product engineers more than ever. Forward-thinking organizations are addressing this challenge by embracing...
Hello everyone, and welcome back to today’s SPK and Associates blog: Why Integration Matters for Modern Engineering and Product Teams. My name is Michael Roberts. I’m the Vice President of Sales and Marketing here at SPK and Associates, where we work with...
The future of Atlassian is here! Leap into the future with Atlassian cloud and unlock speed, scale, and AI-powered teamwork. Atlassian has announced the sunset of Data Center products by March 2029, marking a pivotal shift to a cloud-first future. From Data Center to...