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...
Compliance & Regulatory
DevOps and CloudBees Accelerate Banking Innovation Part 1
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: How To Avoid FDA Warning Letters C.F.R. 820.70(i)
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...
Problems that Engineers in Regulated Industries Face
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...
Streamlining Design Controls For A Leading Medical Device Maker
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...
The Power of the Cloud – Med Device Company Boosts Operational Efficiency and Customer Satisfaction
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...
Leading Medical Device Company Achieves Major Efficiency Boost by Utilizing SPK’s SolidWorks CSV Expertise
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...
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...
Test Management in Windchill RV&S (PTC Integrity)
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 &...
Risk Management in Windchill RV&S (formerly PTC Integrity Lifecycle Manager)
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...
9 Things You Need To Know About Cybersecurity and Protected Health Information (PHI) breaches
In the past 18 months, there have been breaches of security related to protected health information (PHI) at Broward Health, Florida Healthy Kids, and the Accellion FTA Hack. In turn, these breaches resulted in 11 more healthcare organizations getting exploited. ...
3 Top Trends in Product Lifecycle Engineering Tools
Overview In 2015, SPK and Associates co-founder Chris McHale spoke with Peter Thorne, Director at Cambashi, a Cambridge, England-based independent industry analyst firm. With his over 30 years of experience as a software engineer user, vendor, and now analyst, Peter’s...