While PTC’s Windchill remains a popular PLM solution, more and more organizations are embracing SaaS. This transition to cloud-based products has businesses expecting their PLM solution to adapt with them. For many, SaaS isn’t just a want, but a need. Let’s explore...
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...
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
Over the years, Lifetime’s products have continued to grow more complex. With a focus on innovation and continuous improvement, the manufacturer recognized the need to digitize and standardize its engineering and manufacturing workstreams. Paper-based processes and...
Digital transformation is taking over the manufacturing industry. Implementing a digital thread is key to successful digital transformation as it ensures streamlined workflows and accessible data. Digital thread implementation can be enhanced with the integration of...
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
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...
