Jul 23, 2015

Quality Event Investigations, Interviews, and Brian Williams


If you are a follower of television news, you undoubtedly know of the problems that Brian Williams, the NBC television network news anchor experienced in early 2015.  (If you hadn’t heard, he was found to have embellished his experience as a passenger as he was flying in a military helicopter in Iraq while covering a news story.  He claimed his helicopter was hit by antiaircraft fire, when, in actuality, it was the lead helicopter; his aircraft was not affected [1].)  In April 2015, it was reported that there were other exaggerations attributed to him [2].

There are two different views we can take in considering how Mr. William’s story changed over time.  On one hand, his exaggerations might be blamed on showmanship or intentionally telling the proverbial “fish that got away” story. On the other hand, his inflation of the facts could be due to what happens when one’s memories are saved, retrieved, subtly changed, resaved, and then found to have drifted considerably from the original event [3]. (Either case is a bad situation for a journalist to put himself in.)   If we think of it this way, Mr. William’s predicament provides a learning opportunity for those involved in deviation and quality event investigations.

Jul 21, 2015

European Supply Chain: A Series of New Regulations in Force

Director Operations

The new EU Directive 2011/62/EU and its delegated acts keep on changing the pharmaceutical supply chain. The directive introduced numerous Delegated Acts with different time schedules and had some impact on revisions of several chapters of the EU-GMP Guidelines.

Here is the status quo of the Directive and the delegated acts:

Already in 2011, the European Commission published Directive 2011/62/EC, the so-called Falsified Medicines Directive (or FMD).The main goal was the fight against counterfeit medicines. In 2014 the technical characteristics of one key requirement were defined, the unique identifier delivering the possibility of verification of the authenticity of single folding boxes. This will be a 2D barcode (data matrix). As this new requirement will become active in 2018, it is time to start defining strategies for both technical implementation and change control strategy.

Jul 16, 2015

Get Products to Market Sooner by Systematizing Quality Cycles

Getting a product to market is not a one-time event—it involves a series of cyclical processes. Is every phase along your organization’s ongoing quality continuum as efficient as it should be?

by James Jardine

Marketing Communications, MasterControl

Creating a product and getting it to market is not a one-time achievement. It entails a series of ongoing cyclical processes.

It all starts with an initial idea developed with a collaborative team. Input is gathered from all the necessary sources and then tweaks to the original concept are made as needed. Many different types of reviews, approvals, and regulatory checks are also required during this development stage. Then it’s time to provide suppliers or vendors with specific orders to ensure all the puzzle pieces will fit together as planned. Once your organization’s employees receive all the training they need to make the product according to the specifications that have been devised it feels like you’ve almost reached the finish line. Now you just flip a switch and watch as the magic is made while you celebrate your magnificent accomplishment, right?

Jul 15, 2015

eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators

 Beginning August 14, 2015, device makers must 
submit all medical device reports electronically.

by Alex Butler, Product Manager
Life Science Applications (LS APPs), MasterControl   

In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format via the Electronic Submissions Gateway (ESG), rather than in paper form through Form FDA 3500A. The compliance deadline of August 14, 2015, is fast approaching! Will you be ready?

Here are some last minute tips for going all electronic.

Jul 14, 2015

Don't Just Fix It: Find It Before Your Customer Does

When mistakes happen in your 
company,  who takes the blame?
by Anna Thornton
Analytics Operations Engineering

It is human nature to find a single cause of a problem, fix it, and assume everything is fine. In fact, the use of a scapegoat is documented in writings from four thousand years ago. All of the sins of a community were laid on the head of a single goat that was then driven into the wilderness, relieving every one of their problems. Four millennium later, we still believe in the power of the scapegoat to take away problems. When a product fails in the hands of a customer, triggering a recall or creating excessive warranty costs, companies quickly find a solution (or fire someone) and assume all is well. Mistakes are embarrassing and it is easier to assume they won’t happen again. The GM recall case is a classic example of this. News articles focus on one or two issues: the engineer who signed off on the change or the automotive safety reporting requirements. Everyone is pointing a finger at each other.

Jul 9, 2015

Ensuring Proper Training for Clinical Research Staff in Less Time

President & CEO, IMARC Research

There has never been a more exciting time to be involved in clinical research. We’re seeing more advances in life-changing medical devices and pharmaceuticals than at any other time in history, creating a growing demand for qualified clinical research associates.

The U.S. Bureau of Labor Statistics estimates jobs for medical scientists will grow by 13 percent [1] from 2012 – 2022.

It only makes sense then that clinical research professionals need continuing education to keep up with a rapidly evolving industry.

Jul 8, 2015

It’s Hot in Here—Quality, Compliance, and Romance

Editor, MasterControl Insider

Sun, spice, and romance—they’re everything I associate with summer. And I’m not talking about your love life, but your quality system.

Indulge me for a moment and let me talk about the two things—quality software and romance—that preoccupy me most. I’m a full-time marketing writer and a newly published romance author. By day, I write about quality and compliance. By night, I write about people who live happily ever after (known as HEA to romance readers).

It’s no wonder that two of my colleagues asked me (read: it sounded very much like a dare) to link romance with quality management system. It took me about 60 seconds to realize that, in fact, establishing a QMS or overhauling an existing system is similar to finding and nurturing a romantic relationship.

Jul 7, 2015

From Open Payments to OpenFDA, the Push for Global Transparency is Accelerating

Transparency leads to happier patients, 
better trials and lower costs, advocates say.

by Lisa Weeks, Marketing Communications Specialist, MasterControl

Transparency has been a hot topic in life science circles in recent years. So hot, in fact, that it has almost become a buzzword, which implies that it lacks real substance or staying power. Transparency advocates, who are pushing to make health industry data—everything from clinical trial results to procedure pricing information—more accessible, would disagree.

Jun 30, 2015

Why Medical Device Companies Must Get Serious About Cybersecurity

Device makers aren't doing enough to
protect their data or devices, experts agree.

by Lisa Weeks, Marketing Communications Specialist, MasterControl

The Anthem data breach should be a wake-up call to the health care industry, according to security experts. On February 5, 2015, hackers stole the social security numbers and personal information of 80 million Anthem members and employees, leaving them vulnerable to identity theft and blackmail.1 While the insurer may be one of the biggest health care companies to suffer a breach, it certainly isn't the first. 

Editor’s Note: This post is an excerpt from the white paper “Five Trends Transforming the Medical Device Industry in 2015.” 

In October 2014, the Department of Homeland Security investigated more than 20 suspected cases of cyberthreat in hospital equipment and medical devices, bringing some well-known health care giants under scrutiny.2 That same month, the FDA published a cybersecurity guidance for medical device makers, outlining the security measures developers should build into their products when seeking approval for a new device.

Jun 25, 2015

4 Reasons Why Document Review is Crucial to Compliance

When was the last time you reviewed 
your quality documents?
by Cindy Fazzi
Editor, MasterControl Insider

When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

“For organizations using a paper-based or hybrid system, a common problem is lack of document review,” said Jackson. “They have internal policies that require them to review their SOPs, work instructions, and other critical quality documents on a regular basis, but they fail to track them down. When that happens, they are violating their own policies.”

Jun 23, 2015

Study: mHealth Will Soon Be the New Normal in Health Management

More than half a billion smartphone users 
are expected to be using mobile 
health apps this year
by Lisa Weeks, Marketing Communications Specialist, MasterControl 

Mobile health, or mHealth, has gained significant momentum over the past couple of years, and it will continue to influence product development in 2015. Millennials raised on technology are providing device makers with the unprecedented opportunity to sell directly to consumers in the form of wearable devices and mobile health applications that allow patients and physicians to interact clinically from different locations. The popularity of mHealth tools has been fueled by the growth of the smartphone industry.

Editor’s Note: This post is an excerpt from the white paper “Five Trends Transforming the Medical Device Industry in 2015.”

Jun 18, 2015

Science Fiction Meets Science Fact: How 3-D Printing is Revolutionizing Medical Devices

Scientists think it will be possible to 
print a 3-D heart in 3 to 5 years' time

by Lisa Weeks, Marketing Communications, MasterControl

Imagine a time when a clinician can modify and manufacture an implant sized for a particular patient on-demand in a health care facility—or print a human organ as easily as a paper document. As futuristic as it sounds, that time is not far off, according to scientists who continue to find new and truly mind-blowing ways to apply three-dimensional (3-D) printing techniques to the medical field.