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Top Lessons Life Sciences Companies Can Learn from FDA Warning Letters

Life Sciences / August 9, 2017

If your company has ever received a warning letter from the U.S. Food and Drug Administration (FDA), you know how serious they can be. It’s a shot across the bow, serving as notice of problems but also providing an opportunity to improve before more serious issues occur.

With that in mind, let’s look at the top issues that lead to warning letters, and what companies can do to avoid finding themselves in the same boat.

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Turning Problems into Opportunities with Lean Six Sigma + How Smart is Automation?

Top Stories / August 2, 2017

This week’s Verse industry roundup spotlights the world of quality. We have compiled articles from Quality Digest that include tips for delegating workloads, one from Quality Magazine on how two organizations turned problems into opportunities with Lean Six Sigma and we conclude with one of our own blogs on automation and just how smart it really is.

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What Does the Internet of Things (IoT) Mean for Life Sciences?

Life Sciences / July 26, 2017

The number of networked medical devices is expected to grow 500% over the next decade, putting Internet of Things (IoT) front and center for life science companies looking to tap into this growing market.

In this post, we’ll look at what IoT means for pharmaceutical and medical device manufacturers, including new applications, emerging risks and the expertise companies will need to be successful.

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4 Questions to Ask When Choosing a Cloud-Based QMS

Quality Management / July 19, 2017

With many big purchasing decisions, one of the biggest risks is not asking the right questions from the outset. After all, we often don’t know what we don’t know until after the fact, when problems are more likely to arise.

The same is true when choosing a cloud-based Quality Management System (QMS). You might feel good about your initial decision, only to experience buyer’s remorse once the glitches and process bottlenecks start to pile up.

To make the right choice in a cloud-based QMS, your selection process should include questions in areas such as flexibility, integration, vendor support and cloud privacy.

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The Crucial Role of Notifications in Life Sciences + Closing the Digital Loop

Top Stories / July 13, 2017

This week’s roundup brings you the latest from the Life Sciences industry.

First, we revisit the ever-important topic of notifications to see the role they have in Life Science organizations. Then, we look at an article from MPO that gives insight into developing a more efficient medical device supply chain. Finally, quality magazine shows us how to close the digital loop, from engineering to manufacturing.

Happy reading!

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How to Explain the Value of a Cloud-Based QMS to Your Boss

Quality Management / July 5, 2017

By next year, companies will have the majority of apps and software platforms residing in the cloud, according to a cloud computing survey by IDG Enterprise. While adoption of cloud-based Software as a Service (Saas) and Platform as a Service (Paas) solutions is soaring, more than 50% of companies are still evaluating which business functions to move to the cloud.

What statistics on soaring adoption rates don’t show is how hard implementation can be when you’re trying to get your team on the same page. Concerns about requirements, cost or security can all quickly derail a project before it ever gets off the ground.

To make the case for a cloud-based Quality Management System (QMS), you’ll want to focus on business benefits like profits, overhead, and productivity, all within the context of risk and operational excellence.

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7 Golden Rules of Effective Corrective Action

Quality / June 28, 2017

One of the last things you want to hear after a safety or quality incident is “I knew this would happen.”

Why is this statement so common when a problem occurs? Often, it’s a history of similar incidents, previous near-misses, or simply because the warning signs were always there. No matter the reason, it’s a sign that your corrective action process is not working.

With that in mind, let’s look at 7 golden rules of corrective action that will help boost your effectiveness and prevent problems before they happen.

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Cybersecurity in the Cloud: How Safe is Your Data?

Quality Management / June 21, 2017

Cloud-based software is a growing option for quality management solutions. It is a cost-effective way to lessen IT burden and build a software solution that works best for you.

But with new technology comes a new set of cybersecurity challenges. Cybersecurity threats pose ever-present and constantly changing challenges to organizations, especially those that deal with sensitive, personal and competitive data. Consequently, people may be hesitant to adopt a cloud-based software solution.

However, there are cloud-based options that are secure and lessen the risk of a cybersecurity attack.

Here are three things to do and look for when looking for or setting up a cloud-based quality management system.

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4 Decision-Making Styles + Forging Elite Quality and Compliance

Top Stories / June 14, 2017

This week’s roundup focuses on quality and compliance. We have compiled articles on decision making styles and when to use them, how manufacturing and logistics industries are growing in terms of goods with less workers and we conclude with one of our own blog posts on forging elite quality and compliance. Enjoy!

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7 Must-Haves for Any Cloud-Based QMS

Quality / June 7, 2017

According to a survey by IDG Enterprise, a full 7 in 10 companies now use at least one application in the cloud. Cloud-based platforms are now common in nearly all fields of business, a growing trend that includes Quality Management System (QMS) platforms.

If your team is considering using a cloud-based QMS, this checklist of must-haves will help you ensure you get a solution that fits your business.

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