IT outsourcing has become prominent in nearly every area of the economy -- to the point that its benefits are taken for granted. We're aware of the saving of money, of cloud technology providing cost effective high availability infrastructure, and so forth. The...
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.
This week’s posting deals with Rational licensing on the Windows platform. We are going to have a look at setting up a Windows Rational license server and how to configure it. It also turns out that with the arrival of Rational 7.1.2, a new version of the license...
Everyone loves a one-click installer, but setting this up can be a headache, especially when a company changes the way this is done. You can setup your installation script to install both PADS9.3 and PADS9.3_update1 with a double-click of the mouse! Here are the first...
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 week we take up the topic of creating IBM Rational patch install areas for pre-7.1 versions. As we have discussed in previous weeks, there are a number of tools in Rational 7.1 and beyond that introduce much automation into patch management. However, there are...
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...
As Senior Systems Integrator for SPK and Associates, a California based IT services company specializing in infrastructure management services, I recently completed an interesting project. The goal was to create an ESX cluster for a small engineering group...
This week we continue on the topic of installing using IBM Installation Manager. But with a bit of a difference. Instead of bringing up the IM install GUI and using it to conduct the installation, we will take a step toward greater installation automation and create...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
In this post, we talk about how to use IBM Rational Packaging Utility along with Installation Manager to first create an installation package containing multiple products (in this case ClearCase and ClearQuest 7.1.2, and License Key Administrator 8.1.1). Then we will...
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...