When it comes to product innovation and project development, the role of the project manager cannot be underestimated. That's why it's important to take an objective look at the skills and resources available in your organization and determine if a skills gap exists...
Requirements/Test Management
Avoid Fatal Product Design Flaws with QA
The difference between quality assurance (QA) and testing is often misunderstood. In fact, the terms are frequently used interchangeably. However, testing is actually just one part of QA. Quality assurance, on the other hand, covers a larger, more holistic part of the...
Avoid Budget Overruns and Unhappy Customers with Better QA and Testing
Any project can be divided into different parts including requirements gathering, design, implementation, documentation and so on. One key aspect of the project lifecycle is quality assurance (QA), but it's often overlooked. Although almost all project managers...
How to Conduct System Hardening Using the Defense Information Systems Agency’s (DISA) “Gold Disk”
Holes in your IT infrastructure can make for some awkward situations. Whether you're dealing with sensitive customer information, upcoming product designs, or simply just don't want people messing with your stuff, maintaining system integrity can be difficult....
How to Monitor Your APC UPS Units – Part 1
Picture your ideal company technological infrastructure. Servers to handle day to day tasks, servers to do engineering simulations, network equipment to handle communication, network-attached storage for your company critical data, and last but not least,...
Static Analysis: Improving Quality by Finding Coding Issues As Soon As Possible
Many companies utilize static analysis tools in some fashion. However, we often find they are not leveraging them to their fullest potential. At SPK and Associates, we believe in driving quality up front, at the Engineering Desktop, and not relying solely on finding...
Creating a low cost, high performance ESX cluster
As Senior Systems Integrator for SPK and Associates, a California based IT services company specializing in infrastructure management services, I recently completed an interesting project. The goal was to create an ESX cluster for a small engineering group...
Running Pro/INTRALINK 3.4 on Windows 7, 64-bit
I recently came across a forum post asking for advice on the combination of running Pro/Intralink 3.4 on Windows 7 64-bit. In short, I’m happy to report that we’ve been using this combination without incident: Microsoft Windows 7 Professional 64-bit SP1, PTC...
Computer System Validation: A Closer Look at 21 C.F.R. §820.70(i) and FDA Warning Letters
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Security layers on a modern website
Last time, we looked at a basic website design. Now it’s time to start digging into the details around what’s really being used behind the scenes. This time, we’ll focus on security aspects. When a user starts their browser and connects...
Insights from Greenlight Guru’s 2023 MedTech Industry Benchmark Report
In a year of unexpected twists, the medical technology (MedTech) industry finds itself amidst shifting sands. So, Greenlight Guru’s 2023 MedTech Industry Benchmark Report is a treasure trove of insights into MedTech trends and the landscape. Let's deep dive into some...
Best Practices for Successful eQMS Implementation
Are you a medical device manufacturer seeking to overcome the challenges of your current quality management? Let me help you show you the light. In this blog, we will show you the advantages of adopting an Enterprise Quality Management System (eQMS). Better yet, one...