Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
PDM/PLM-Product Data and Lifecycle Management
Using IBM Rational Packaging Utility
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...
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...
Using Windows ClearCase Variables – CLEARCASE_PRIMARY_GROUP and CLEARCASE_GROUPS
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...
Computer System Validation: A Closer Look at 21 C.F.R. §820.70(i) and FDA Warning Letters
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Using the New ClearQuest Eclipse Client
Have you noticed that Rational ClearQuest 7.0 now comes with a new default Eclipse client? Wonder what is happening to the old Windows client and what the difference between the two is? Then this post is for you! Download the attached PDF file below to get the...
Upgrading from ClearCase/ClearQuest 7.0 to 7.1
As an IT engineering expert for SPK and associates, a California based IT services company, I write blog posts on topics such as Software Configuration Management and other Engineering Applications. This week I’d like to blog about my experiences in upgrading...
Defining PDM and PLM Software: Why You Want Both
Choosing and evaluating products for managing data is a daunting task. With the ease of access to broad, general information – which is often conflicting – getting your decision-makers and Very Important People using the same vocabulary is the first step to developing...
Welcome to SPK’s New Website and Blog!
Welcome to SPK’s new website and blog! We’ll be posting a lot of great tech info here in the coming week and months, so be sure to subscribe or check back often. You’ll hear from everyone on our team at some point or another – which is good since more minds = more...
