Cybersecurity should be baked into the onset of IT and product development processes. Additionally, treating cybersecurity as an afterthought opens your organization up to vulnerabilities and risk. Therefore hardening your IT product cybersecurity with a tool like...
What is Computer Systems Validation (CSV)? Additionally, why does the Food & Drug Administration (FDA) require them for the Medical Device industry? More importantly, how can CSVs be efficiently completed and managed? Let’s explore why you can’t skip that...
In Part 1 of this article, we talked about the banking innovation industry threats and market conditions. We discussed how DevOps and CI/CD tools can help to mitigate threats. We also discussed why tools like Jenkins, CloudBees CD/RO and CloudBees Software Delivery...
Welcome to part 1/2 of our blog exploring banking innovation industry threats and market conditions. We will discuss how DevOps and CI/CD tools can help to mitigate threats. Part 1 will also discuss why tools like Jenkins, CloudBees CD/RO and CloudBees Software...
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. In fact, the content in this article may not be “new news” for you either, but as with other regulatory requirements, it’s useful...
https://www.youtube.com/watch?v=Og6826J7EOo Video Transcript: I'm Carlos Almeida, VP of Engineering at SPK and Associates. I've spent most of my professional life doing software engineering. 25 years plus in the world of high tech in the electronic design automation...
SPK helps this global enterprise to boost product development efficiencies, increase compliance reliability, generate reports with a single click, and shave weeks off their development/release cycles. The Client A respected global medical device powerhouse, with more...
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...
Background Apublicly traded medical device manufacturer with 33,000 employees and several international locations approached SPK and Associates for assistance in streamlining their validation processes. The validation process took months, but the customer wanted...
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...
The importance of test management, especially in highly-regulated industries, cannot be overstated. Efficient management of testing requirements leads to safer products, effective production, and satisfied customers. The PTC Windchill Requirements Validation &...
An important part of creating any product intended for use in any regulated industry vertical is that the manufacturer should have identified all of the risks involved in using the device. Then, they must have done their best to mitigate those risks before their...