Whenever I get a chance to see any kind of motor racing I am amazed at how many displays the engineers use to watch and monitor all the data coming from the cars. Modern performance racing cars produce a lot of data about the engine, tires, fuel consumption,...
Automated development, rather than just automated builds, offers a more holistic approach to automating the development process including building, testing and deployment. It is the cornerstone of Continuous Integration (CI). CI uses a model of small incremental...
One of the common tasks for any system administrator is managing disk space on a server. It doesn't matter what operating system the server is running, free disk space is always something you keep an eye on. I won't go into a boring lecture on why managing disk space...
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.
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...
SPK helps a tech manufacturer to increase security and availability of its CAD systems and data by moving them to the cloud—while helping them to save $30k per year. The Client A well-known maker of power distribution units for IT racks and related equipment...
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...
BackgroundA diversified medical device company has a leading position in the global endoscopy device space. In this market, the company generates growth and differentiates its products primarily through incremental innovations and investment in research and...
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...
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...
How SPK was able to unify globally dispersed engineering teams to work, and communicate, in real-time. THE CLIENTA leading medical device manufacturer was facing a problem common to firms with growing engineering operations: As their product-development team grew,...
How SPK successfully improved a client’s engineering productivity and quality by creating a connected business system, leveraging separate, complementary platforms. Bridging TechnologiesMedical device manufacturing is a highly regulated industry. Even the slightest...