Remote working is an effective way to keep your business running 24/7, mitigate downtime and tap into new markets or expertise. Now, the world is flooded with companies utilizing remote work, digital nomads and gig workers to keep their competitive edge. But, the rise...
Compliance & Regulatory
SPK Accelerates Fortune 100 MedDevice Product Sale
Our client is Fortune 100 Medical Device manufacturer. SPKAA acts as a product cybersecurity managed service provider for their hospital products which have embedded Windows or Windows OS. Fortune 100 MedDevice Problem For over 10 years, SPK has provided ongoing...
Use Nessus To Harden Your Cybersecurity
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...
How To Complete Computer Systems Validation (FDA)
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...
DevOps and CloudBees Accelerate Banking Innovation Part 2
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 CloudBeesSoftware Delivery...
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...
CloudBees and DevOps Accelerate the Banking Industry Time to Market, Part 1
The Threats and Market Conditions The banking and financial industry faces some tough challenges that many other industries do not. The continually increasing regulations. The continuous threat of cyber-attacks. The disruptive innovation from outside of the sector....
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. ...
5 Best Practices That Could Have Protected You From Log4J
Log4j: What Is It? On December 9, 2021, a critical exploit named "Log4j" was disclosed to the world. This exploit was particularly harrowing due to the fact that the software library which it targeted is so widely utilized. “Log4Shell” (CVE-2021-44228,...
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...
How AWS Cloud Solutions Can Help Your Manufacturing Enterprise Maintain Its Competitive Edge
Executive Summary In 2020, public and private cloud-based solutions like Amazon Web Services surpassed traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to...
How Hybrid Cloud Can Turbo Charge Your Manufacturing Enterprise
Executive Summary That’s the year public and private cloud-based solutions are set to surpass traditional data centers in terms of overall spending. In 2017, nearly two thirds of spending went toward private cloud solutions. Cloud usage exploded in 2017, to the tune...