This week we want to cover a utility that allows users to manage the buildup of files that eat up space on your storage device. We are speaking about WinDirStat, which is a tool that presents a graphical view of your entire storage drive (or from a folder level)....
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...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
Many companies utilize static analysis tools in some fashion. However, we often find they are not leveraging them to their fullest potential. At SPK and Associates, we believe in driving quality up front, at the Engineering Desktop, and not relying solely on finding...
Improve Your Ability to Sell Software into Medical Device Companies – In this paper we will share five things you can do to make your software application more attractive to medical device companies.
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.
Read about one of our customer experiences in helping to accelerate their software build system.
Software Development Lifecycle (SDLC): In our last article we discussed speeding up your build by leveraging tools such as Electric Accelerator. In this article we will discuss the process of Continuous Integration (CI) along with a customer experience utilizing...
Holes in your IT infrastructure can make for some awkward situations. Whether you're dealing with sensitive customer information, upcoming product designs, or simply just don't want people messing with your stuff, maintaining system integrity can be difficult....
When on the internet, there's always concerns of security. If you're listening on some services but not others, you need to modify the Linux firewall to allow this. Also, if there's undesirable clients accessing ports and hacking, IPTables is an effective...
Software asset management tools, particularly license usage and monitoring software are gaining more and more interest among large corporations. It should come as no surprise since by utilizing such tools they stand to gain upwards to 10% in cost reductions and that...
Developed by Electric Cloud, Electric Commander is an extremely versatile tool for enhancing and automating your organization’s software development build-test-deploy cycle. Commander makes it possible to eliminate unnecessary lag time between phases of the...