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CAPA:  A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends

SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends.   One of the problem areas most often cited in company audits continue to be the CAPA system/program.   This month we will take a look at some of the latest FDA...

Zoom surpasses its growth goals with Atlassian Cloud products

Zoom surpasses its growth goals with Atlassian Cloud products

Zoom has leveraged Atlassian Cloud products to maintain solid security and firm administrative control – not to mention Atlassian’s 99.9% uptime SLA – all while growing exponentially. It’s March 2020: the month when the world changed almost overnight, we learned the...

Automating Cloud Infrastructure to Accelerate DevOps Practices

Automating Cloud Infrastructure to Accelerate DevOps Practices

The practice and philosophies of DevOps have become vital to nearly every software development and IT business.  DevOps, standing for “development” and “operations”, consists of practices aimed at streamlining the software development lifecycle.  Its goal is to deploy...

Next Level of Industrial Automation with PTC Windchill+ and Balluff

Next Level of Industrial Automation with PTC Windchill+ and Balluff

Intro A warm welcome from my side. My name is Floren Hamler. I'm representing the Balluff Group. We are based in Germany, close to Stuttgart. Some facts about Balluff: we have half a billion euros in sales, 4,000 employees worldwide, more than 35 own sales...

Exclusive Behind the Scenes at Atlassian Team ’24

Exclusive Behind the Scenes at Atlassian Team ’24

Team ‘24 launched in Las Vegas on April 30th, marking a milestone amidst a year of remarkable growth for Atlassian.  With over 300,000 customers now in their fold, they've introduced several new products and enhancements. Examples include Compass, Jira Product...

The Ultimate Jira Data Protection

The Ultimate Jira Data Protection

Remote work is here to stay, and companies are turning to cloud-based solutions to support their teams. Atlassian's suite of products is a top choice for businesses worldwide. But, many businesses are still unsure about its built-in data protection capabilities....

Unique Threat Intelligence

Unique Threat Intelligence

Ensuring online data security is one of the main priorities of every organization. Threat intelligence is an important aspect of these security measures. Threat intelligence is all the knowledge that helps organizations understand and prevent security threats. Let’s...

Resiliency with Microsoft Azure

Resiliency with Microsoft Azure

When researching cloud computing services, there are many key components to analyze. A main factor many organizations look at is the resiliency of a service. Resilience is about how well a system can recover from a disruption or system failure. It can range from...

Confluence Cloud Tutorial for Beginners

Confluence Cloud Tutorial for Beginners

Hello and welcome to this video Confluence Cloud tutorial for beginners. I'm Michael Roberts, Vice President at SPK and Associates. Today, we're exploring Confluence which is an Atlassian product. You can either watch the video above, or read the transcript below....

4 Advantages of SolidWorks Cloud PDM (Updated 2023)

4 Advantages of SolidWorks Cloud PDM (Updated 2023)

Considering the leap to cloud-based CAD and PDM solutions? A move to platforms like SolidWorks 3D CAD in the cloud paves the way for unmatched flexibility. Imagine accessing intricate engineering data from anywhere at any time. And, the benefits don’t end there. In...