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Rachel Beavins Tracy

Recent Posts

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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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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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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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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Risk-Based Thinking for Life Sciences: 3 Places to Integrate Risk

Life Sciences / May 10, 2017

Risk has always been essential to ensuring quality in pharmaceutical and medical device manufacturing. But with the latest version of ISO 9001, risk is now officially part of the management system standard.

One of the biggest changes in ISO 9001:2015 is the replacement of preventive action with risk-based thinking requirements in context, leadership and planning sections.

Experts will say risk-based thinking is a watered-down version of more robust risk management processes, but the guiding principles are the same. Identify your hazards, consider the potential consequences and take action as necessary.

With that in mind, let’s look at 3 critical areas life sciences companies can integrate risk to improve quality and safety.

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4 Hidden Risks in Life Sciences Manufacturing

Life Sciences / April 26, 2017

Pharmaceutical and medical device manufacturing is all about managing risk. How do you take a product from concept or molecule to finished product in a way that minimizes risks to patients and the company?

Organizations tend to focus on a standard set of risk tools, relying on things like Failure Modes and Effects Analysis (FMEA), risk matrices and the Risk Register to ensure risks are caught before they become problems.

And while these tools are incredibly valuable to risk management in general, sometimes it’s the process or system itself that creates hidden risks.

In today’s post, we’ll look at 4 of these risks, and how companies can address them. 

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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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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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