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Rachel Beavins Tracy


Recent Posts

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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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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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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What Does the New FDA Chief Appointment Mean for the Life Sciences Industry?

Life Sciences / April 20, 2016

In late February, the Senate confirmed Dr. Robert M. Califf as the new commissioner of the Food and Drug Administration (FDA). He moves into the role from his previous job as deputy FDA commissioner for medical products and tobacco, and before that Califf directed the Duke Clinical Research Institute.

While his confirmation came as no surprise, many in the pharmaceutical and biotech industries are wondering how Califf’s appointment will impact their businesses. Here are a few things to know about the change in leadership.

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4 Ways to Get More Done This Week With Your Quality Management System

Quality Management Software / July 15, 2015

 

Summer is here, and with it comes all sorts of fun things competing for our spare time. Beautiful weather for getting out and exercising, lounging on your patio, maybe even a long weekend or a much-needed vacation. Who wants to be slaving away at a desk while everyone else is out playing?

Of course, to join the fun you’ll have to get your work done first. To help you break free from long hours at the office, we’ve compiled a list of 4 ways you can get more done this week by leveraging key tools in the Quality Management System (QMS).

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6 Applications to Keep Your FSMS Running Smoothly

Food safety / July 8, 2015

 

Last week was a little bit crazy for me, with multiple projects, opportunities and new ideas competing for my attention. By the end of the week, my desk was strewn with scraps of paper with little lists on it, and, unfortunately, I hadn’t completed my to-do list. The result? I had to work over the weekend (insert sad trombone sound).

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