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...
Windows ClearCase has a couple of very useful environment variables - CLEARCASE_PRIMARY_GROUP and CLEARCASE_GROUPS. These variables can be a bit confusing at first blush, but they turn out to be rather important for controlling access to VOB elements, and creating...
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Many customers of SPK & Associates utilize the IBM/Rational suite of products. As IBM partners we are often asked to define, configure and deploy IBM tools and processes. SPK has provided Engineering Technology Services to Medical Device companies for over 12...