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.
Cybersecurity
CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends
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...
Security layers on a modern website
Last time, we looked at a basic website design. Now it’s time to start digging into the details around what’s really being used behind the scenes. This time, we’ll focus on security aspects. When a user starts their browser and connects...
Enterprise Storage – Do you really get what you pay for?
In my last blog post, I touched on my experience with Network Appliance filers and remote server monitoring. This week, I will be discussing alternative storage solutions, and how they measure up to one of the biggest players in the Network Attached Storage...
How to Build a Corporate Web Infrastructure
As an IT professional, one question I’ve heard more than once is: “Why do I need you – I can setup a computer, a web server, a database, etc”. My answer varies based on the audience but essentially comes down to: if you are entrusted with a company’s...
