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.
Your IT service desk is about to change. Find out what's shaping the future. Three factors — enterprise service management (ESM), collaboration, and intelligent service management — are driving the transformation of the service desk. To better meet customers’ needs...
CloudBees SDA Analytics has more power than you think One of the main features of CloudBees SDA is CloudBees Analytics, powered by ElasticSearch. It’s a powerful tool for displaying continuous integration data and there are loads of useful metrics available from...
“It’s Time to Get Rid of the IT Department.” That was the title of an opinion piece recently published in the Wall Street Journal. Provocative? Sure. My answer to this is not “yes,” but many of the author’s points are valid. The Same Old IT Department? No, the IT...
(Originally published in 2012, updated January 2022.) One of the common tasks for any system administrator is managing disk space on a server. A common question is how to increase disk space on a linux system. I won't go into a boring lecture on why managing disk...