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Compliance & Regulatory

SPK Accelerates Fortune 100 MedDevice Product Sale

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

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)

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

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...

5 Best Practices That Could Have Protected You From Log4J

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

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 Hybrid Cloud Can Turbo Charge Your Manufacturing Enterprise

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...