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10 months ago
 

Growing Craze for Autonomous Car Technology

Autonomous vehicles are quickly evolving from science fiction to reality.

There is no denying it: Autonomous cars, also known as self-driving cars, could be generally available on our roads as early as by 2020 – so it’s time to start thinking about all of the legal, regulatory, and technological impacts.

It’s no surprise that our dependency on software is drastically increasing – and autonomous vehicles are a prime example of cars packed with technology.

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10 months ago
 

7 Steps to Embracing Enterprise Agile

There is tough competition in the enterprise business world, as developers need to constantly create innovative software. The ability to embrace Enterprise Agile helps your team deliver better software – and at a much faster pace.

Choosing Enterprise Agile provides: “the opportunity to finally have the full benefit of Agile adoption and forget all, or at least some, of the delusions they had with Agile on the team level.”

Successful adoption is a difficult task, however, and there is plenty of room for improvement.

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10 months ago
 

On-Demand: Software Development to Boost IoT Innovation

In case you missed our recent webinar, “Developing to Maximize the IoT Revolution,” the complimentary on-demand recording is now available for you to view.

Click the following banner to learn more:

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10 months ago
 

Introducing TeamLive’s Kanban Extension for Polarion

Embracing different methodologies in the workplace can be an interesting new challenge – but Polarion enjoys helping our customers reach new limits. As we look forward to sharing more details about enterprise agile, it’s worth pointing out that Polarion is – and will always remain – Kanban compatible.

With each new version release, we remain dedicated to making it as easy as possible for customers to take advantage of strategies to get work done in a faster, more efficient manner.

WB
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11 months ago
 

Webinar: Learn More About What’s New with Polarion 2016

If you want to learn more about some of the great new features in Polarion 2016, Jiri Walek, our VP of product management, will host two webinars on Thursday, April 21.

To register for the webinar, please click on one of the following banners:

Polarion20161


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11 months ago
 

Medical Device System Software Validation Documents

As I discussed in my last blog, software used as a platform to support the manufacture of product or in the product quality management system (QMS) must be validated (as required by 21 CFR §820.70(i)). The process is the same process used to develop design controls for a medical device without the requirement for compliance with ISO 62304 [white paper: Achieve Fast Compliance with IEC 62304]. Larger medical device firms usually assign this task to their IT department.

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11 months ago
 

Webinar: Developing to Maximize the IoT Revolution

The Internet of Things (IoT) is disrupting the workplace, with increased focus on bridging the gap between software and hardware. To help navigate these challenging times, Polarion Software will host the upcoming webinar: “Developing to Maximize the IoT Revolution.”

During the webinar later this week, hear from Polarion Software Product Manager Mike Borse, as he discusses the following topics:

  • How to prepare your development teams for growing IoT demand
  • Manage requirements for the expected new and shifting IoT standards
  • Maximize existing resources, artifacts, and process investments
  • Why software matters more than ever for your hardware

To register for the upcoming webinar, please click the following banner:

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11 months ago
 

Webinar: The Right QA Enterprise Test Management Solution

The demand to successfully meet growing quality assurance challenges can be difficult. One of the easiest parts to miss is the integral component of software development process. An end-to-end approach encompassing the complete integration of the software development ecosystem is required to provide traceability and compliance.

Polarion Software recently hosted: “Polarion QA is the Right Enterprise Test Management Solution.” You can view the on-demand webinar by clicking the following banner:

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11 months ago
 

Polarion Enterprise Agile: Bridging the ‘Speed vs. Compliance’ Gap

Today’s tough competition means that enterprise developers have to rapidly produce innovative software. Agile methods and approaches have a proven record of delivering better software at a faster pace.

But… and it’s a big “but” in regulated industries, many enterprises must also meticulously document everything they do in order to demonstrate compliance with regulations and standards. The result is a Speed vs. Compliance gap. It’s a bit like having to drive a sports car with the parking brake half engaged.

Let’s face it – when you have to be compliant, you’re never going to be agile in the same way as a business that doesn’t. But your competitors have the same problem. So anything you can do to become more agile can amount to a significant competitive advantage. And that’s where Polarion Software’s lifecycle management solutions can really help you deliver the goods.

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11 months ago
 

Medical Device Software Validation Terminology

To read the first blog of this series, Cloud Computing and Software Validation, please click here.

I was recently speaking with a colleague about the significant software validation burden on life science companies. I found it interesting how difficult it was to sort out our terminology. It turns out that the regulatory agencies – and the Food and Drug Administration (FDA) in particular – have not been consistent in the application of language and definitions.

This confusion adds to the growing complexities that organizations with required FDA oversight might find challenging. I thought it might be valuable to spend some time discussing the various terms to better provide a common reference point.

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