One of the powerful features of a full enterprise product lifecycle management (PLM) system is being able to post process content uploaded to it. For example, adding a watermark, or changing a revision of a document automatically. The idea behind Solidworks Workgroup...
Often times when I am using PTC Integrity (now PTC Windchill RV&S), I am performing the same or similar tasks over and over again. By default, PTC Integrity offers you something called your Quick Query where you can save a query and run it over and over again. But...
Today, we're bringing you a rewind of the most popular IT Infrastructure posts of 2011. Enjoy these favorites from our blog as this year winds down. Number 5 -Â Solve 100 Problems with a Bootable USB Flash Drive What everyday device can be used for troubleshooting 100...
In my previous post regarding wireless security, I mentioned that a single source of authentication for users is the most ideal in a corporate environment. The advantages of using one source for authentication are vast. One of the biggest advantages is that users only...
One item I’ve done repeatedly while doing network consulting services is configuring high availability (HA) networks. The recommended way is Virtual Router Redundancy Protocol (VRRP). This requires that you have two firewalls for every location and they run in...
One of the most important aspects of our Linux server management service is operating system patching. With Windows, Microsoft has made this trivial by means of the Windows Update utility. Microsoft is the single source of the patches, and assuming that the patches...
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...
The goal of a typical system administrator is to get a job or task done as quickly as possible, without worrying about how elegant a solution might be. Reusing any existing scripts, tools, or utilities are always the first line in tackling the job. Often times, the...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
In my last post, I gave an overview of Bacula, the enterprise-level free backup software. For this post I wanted to dig into the software a bit more and show how simple it is to setup a weekly backup job. One of the first things we do at SPK when working with a new...
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.