Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
Software Development & Release 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
Migration of Your ClearQuest User Database in 7 Steps
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...
Leveraging Group Policy to Setup Wireless Access
In my last post, I introduced Clonezilla as an easy way to deploy Windows-based workstations into a corporate environment. But once a workstation enters the corporate network, what sort of policy applies to it? What sort of actions can a user take on their...
Moving IT Help Desk To A Cloud-based Jira Solution
SPK helps a leading nonprofit to streamline its internal IT support, while adopting best practice and saving money. The ClientA socially-conscious nonprofit research center found its internal IT staff overloaded. It’s a small group—just four people—who were tasked...
Using DevOps and Cloud to rapidly respond and scale
BackgroundSPK was contacted by a software company that provides healthcare cost optimization through a web platform. Their mission is to provide customers with a method to reduce spending while maintaining quality healthcare for their employees. With an expanding...
Reducing Software Deployment Time and Necessary Engineer Effort through Custom Automation and UI Implementation
BackgroundA major fintech and financial services firm implemented Electric Flow (now known as CloudBees CD) for software deployment. The organization spent too much money on man hours for weekend and overnight hours due to the need for engineers to “babysit” software...
Continuous Delivery pipeline with CloudBees CD for major insurance carrier
The ClientFounded in the early 1900’s, this major insurance provider administers health benefits to more than 4 million individuals. Because of the types of services this client provides to its customers, they are heavily reliant upon software technology and technical...
Lockheed Martin saves time, money, and tech muscle with GitLab
The world’s largest defense contractor uses GitLab’s end-to-end DevSecOps platform to shrink toolchains, speed production, and improve security. Lockheed Martin Corp., an American aerospace, defense, information security, and technology giant, has adopted...