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7 Medical Device Trends to Watch in 2017

Life Sciences / April 12, 2017

After the mega-merger era of 2015-2016, the passage of the 21st Century Cures Act and a new administration in the White House, many in the medical device industry are wondering what changes are on the horizon for 2017.

It’s unclear whether the U.S. Food and Drug Administration (FDA) or the market will be the biggest driver of change, or exactly how these elements will affect the industry.

In this post, we’ll look at some of the most important medical device trends to watch this year.

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5 Essential Tips for Effective Sanitation + Finding Solutions for Regulatory Compliance and Cost-Efficiency

Top Stories / April 5, 2017

This week’s roundup brings you the latest from the food and beverage industry.

First, Food Quality & Safety Magazine shares 5 tips for reducing foodborne illness under FSMA standards. Then, we take a look at how investing in a food safety system is a smarter long-term investment than risking recall. Finally, EtQ’s Tim Lozier looks at the future of predictive analytics for compliance management in the food and beverage industry.

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7 Ways to Use the Pareto Principle to Improve Quality Management

Quality / March 30, 2017

Quality management experts throughout history have used the Pareto Principle (also called the 80/20 rule) in various ways. Vilfredo Pareto, an Italian economist, first came up with the idea based on his observation that 80 percent of Italy’s land belonged to just 20 percent of the country’s population.

Joseph Juran, one of the fathers of quality management, later adapted it into “The Rule of the Vital Few.”  The ratio doesn’t have to be 80/20, and the numbers don’t have to add up to 100, but the idea is simple: a small number of inputs have an outsized impact on the outputs. For example, 20 percent of causes create 80 percent of your quality problems. In a more familiar example, most of us probably wear just 10 percent of what’s in our closets for 80 percent of the time.

With that in mind, this post looks at 7 ways you can apply the Pareto Principle to improve your quality management efforts.

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Cheat Sheet for Corrective Actions + Security in the Cloud—A Buyer’s Guide for the Life Sciences

Top Stories / March 22, 2017

This week’s roundup brings you the latest from the Life Science industry. In the news, we see the potential implications of Trump’s FDA pick on the medtech and biotech industries. Then, an article from MPO magazine sheds light on the benefits and best practices for corrective actions in the Life Sciences. Finally, EtQ’s blog guides us through everything you need to know when considering cloud software for your Life Science solution.

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Software Validation and Change Control: A QMS Compliance Overview

Life Sciences / March 15, 2017

The U.S. Food and Drug Administration (FDA) requires companies to validate any software used in design, manufacture, packaging, labeling, storage, installation and servicing of finished devices. Companies must also use change control to ensure changes to IT systems don’t create unintended risks. 

But meeting FDA requirements around software validation and change control isn’t always straightforward, particularly if you don’t have in-house experts to guide the process.

With that in mind, let’s take a closer look at what’s required for initial validation, and how to use change control to maintain a validated Quality Management System (QMS).

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The Device Tax is (Almost) Dead + The Importance of Risk Management

Top Stories / March 8, 2017

This week’s roundup is focused on the Life Science industry. Read on for articles from Qmed and Quality Digest experts as they cover topics on the medical device tax and a different approach to data structures. We conclude by looking into the importance of risk management and setting risk parameters.

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6 Ways to Prioritize Action with Risk Assessments

Ask any productivity guru, and you’ll find that effective prioritization is key to getting stuff done. Whether it’s focusing on the one most important thing you must get done today or using a tiered system to sort your to-do list, being able to separate less pressing items from mission-critical tasks is a hallmark of effective and efficient work.

In terms of safety and quality, risk can be an especially useful metric for prioritizing action. In this post, we’ll look at how using risk assessments throughout your quality process can help you better prioritize your activities.

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The Beginning of Quality Management’s Digital Transformation + The Data Boom

Top Stories / February 22, 2017

This week’s Verse Roundup focuses on Quality. In this compilation, you will find information from sites like LNS Research, Quality Magazine and our very own Verse Blog. Topics range from quality management and its digital transformation, to Big Data and why quality is a journey, not a destination.

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Meeting Safety and Quality Goals with a Compliance Management System

Life Sciences / February 15, 2017

Quality and safety, regardless of industry, are not as far off from one another as you’d think. In fact, most organizations share long term goals and don’t even know it. Sure, short term goals may not always be the same, but in the long term they very well can be. In fact, how many of your goals are to maintain a culture of integrity, compliance and consider the needs of customers and stakeholders?

With that said, an effective organization is likely to share both a safety and quality cultural mindset.

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Introducing IMEDS  + Tips to Keep Healthcare Consumers Happy and Loyal

Top Stories / February 3, 2017

This week’s Verse Solutions roundup consists of the latest industry news in the life sciences
industry. We have articles from FDA Voice introducing the Innovation in Medical Evidence Development and Surveillance System (IMEDS), from Quality Digest on keeping healthcare customers happy and we bring you 4 ways an automated system benefits life science companies.

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