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...
Process automation releases your engineers for the work their brains are intended for. That work is creativity and problem-solving. By implementing process automation, you improve the team’s morale. Firstly, they get more focus time for deep work and designing better...
There’s simply too much information. We all know this. So how can the “single pane of glass” (SPOG) dashboard simplify quantitative data? And why is data driven analytics of interest to companies? Every day, more data arrives in our inbox – text messages, reports,...
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...
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...
What is Engineering Operations (EngOps)? Why do you need it, and how do you effectively deploy it?There’s a strange interplay between IT and engineering teams in most firms. That’s because the tech stack that engineers need to design, build, test, and release products...
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 beauty of business process automation How often have we entered the same information into two different systems and wondered, “Why do I have to waste my time doing this?” These are computers, aren’t they? Shouldn’t this information flow where it needs...
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...
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...
