Automated development, rather than just automated builds, offers a more holistic approach to automating the development process including building, testing and deployment. It is the cornerstone of Continuous Integration (CI). CI uses a model of small incremental...
One of the common tasks for any system administrator is managing disk space on a server. It doesn't matter what operating system the server is running, free disk space is always something you keep an eye on. I won't go into a boring lecture on why managing disk space...
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
