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...
Cybersecurity
Navigating Compliance and Cyber Security Concerns in Smart Medical Devices
A COMPLETE OVERVIEW OF SMART MEDICAL DEVICES, THEIR DEVELOPMENT AND THEIR COMPLIANCE CONSIDERATIONS. While the Internet of Things offers great opportunities both for businesses and consumers, compliance and security must be thought through carefully from the very...
8 Myths About Moving To The Atlassian Cloud Debunked
"Oh, the Atlassian Cloud isn't built for Enterprise." As an Atlassian Solution Partner, we’ve seen that most organizations who are hesitant about moving to cloud, aren’t equipped with the right information. This is why we’ve busted the top cloud myths. In this...
Accelerating Product Development with Engineering Operations
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...
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...
Protecting Device Storage Using Windows UWF
In this blog we'll explore how the Windows UWF, Unified Write Filter can help protect device storage against product cybersecurity. The Unified Write Filter (UWF) is a Windows native feature that ensures a system’s data remains as an unmodified, secure baseline. Data...
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...
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,...
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. ...
Podcast: Can IoT Jump These Five Hurdles? Episode 3 – IOT Device Serviceability and Environmental Impacts
In the third episode of our podcast series "Can IoT Jump These Five Hurdles?”, SPK & Associates' Chief Strategy Officer, Rajiv Mistry, explains the challenges of IOT device serviceability and environmental impacts. To see all published episodes, scroll down this...
PLM in the Cloud: Computer System Validation in FDA Regulated Industries
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...
Top 3 Engineering Outsourcing Trends of 2013 from Industry Experts
Predictions are hard to make in any area of life, however short term forecasting is not impossible. Ask a meteorologist for the weather in the next twenty-four hours and you will get a fairly accurate prediction. Ask for the outlook over the next 30 days and you will...