Sep 1, 2015

The Patient is Missing

Clinical volunteers can choose to walk away 
any time they want and to clinical 
trials they may be irreplaceable.


by Amy Musolino
Program Director, New Service Development
Fisher Clinical Services


Recently, I had the opportunity to attend a presentation by Patricia Larrabee, CEO and founder of Rochester Clinical Research. While there, I couldn’t help reflecting on the truly significant contribution that patients play in the success of clinical research. Furthermore, what a burden we often inadvertently place on them as well as our investigator sites.
Pat was the keynote speaker at a recent Insights event and presented the topic “What Does it Really Mean to be Patient Centric?” During her presentation, she discussed the new buzz word in the industry right now, “patient centricity.”

Aug 28, 2015

OMG! The FDA Is Keeping Up With Kim Kardashian, Too

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

Love her or hate her, reality-star Kim Kardashian knows how to get our attention. Whether she’s trying to break the Internet with risqué photos or agonizing over which Rolex to wear, people are watching. Kardashian boasts more than 34 million Twitter followers; 26, 074, 878 likes on her Facebook fan page; and 42 million Instagram followers. Forty-two million! That’s how many people may have seen her infamous July 19 Instagram post praising the morning sickness drug Diclegis® that landed her and drug maker Duchesnay in hot water with the FDA. Kim Kardashian’s greed finally got the better of her,” the author of one op-ed piece for the popular U.K. tabloid the Mirror gleefully exclaimed.1 I’m not so sure. Perhaps Kim Kardashian is smarter than we think.

Aug 27, 2015

FDA Requests Public Input on Quality Metrics Guidance


In line with the general shift towards risk-driven approaches in the quality management world, FDA is now taking steps towards applying those same principles to its own auditing schedule. At the end of July, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) released the draft guidance “Request for Quality Metrics” and is now seeking public input by September 28, 2015 on a number of key points.

The guidance expands on how the FDA intends to act on its ability to request data it would normally inspect during an audit “in advance or in lieu of” an inspection, as it is authorized to do under Section 704(a)(4)(A) of the FD&C Act (added by FDASIA section 706, Records for Inspection). It also points out that failure to provide the requested data is tantamount to refusal to permit an inspection and would render the affected product adulterated according to Section 501(j).

Aug 26, 2015

Three Things I’ve Learned about Quality Professionals

by Jon Beckstrand

CEO, MasterControl Inc.


Over the past 15 years, as the leader of an organization dedicated to improving the success of the quality profession, I have met hundreds of people throughout the world who have a unique mission:  build greater quality into the things we use every day.  I have often asked myself, what do all these people have in common? What makes someone choose to dedicate his or her career to improving quality?   Who are these people who dedicate their lives to making sure that things are done right, that we don’t skip critical steps?  Whether it’s making sure that you aren’t using yesterday’s version of a work instruction or that you are trained properly on changes crucial to the implementation of a corrective action, quality professionals are ever vigilant about maintaining quality standards and compliance. 

Aug 25, 2015

Infographic: FDA Inspections By The Numbers


During the last 15 years, FDA has gradually 
ramped up the number of annual inspections.
by Tony Chen
CEO and Co-Founder of FDAzilla


Up until recently, it has been difficult to get data on FDA inspections.  Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection?

Over the past year, we’ve worked to get at this data and published this first infographic focused on FDA inspections. 

As you might imagine, the FDA has had a busy 15 years. Over that time period, they have conducted over 600,000 inspections spanning 150,000+ facilities, issuing 130,000+ FDA 483s, and utilizing 4,500+ inspectors.

Aug 20, 2015

Education And Corrective Actions: The Solid Foundation Of Food Safety Culture

A good food safety culture really means that 
everyone within your organization shares 
the same mindset, values, ambitions, 
and practices of food safety.
by Sam Lewis
Associate Editor, Food Online



There is no doubt about it; it is getting more and more difficult to be a successful food processor or manufacturer. The supply chain continues to grow and become more complex, food safety regulations across the globe are becoming increasingly stringent, consumer preferences are constantly evolving, and the food industry’s workforce seems to be continuously changing. All of these trials amplify the importance of managing risks, keeping the public safe, and maintaining consumer loyalty to your brand. So, what can you do to manage this incessantly-growing number of risks?

It is imperative for you to create a culture of food safety. It is also important to note that food safety culture is not a food safety program. While both are systematic approaches to food safety, a food safety culture means influencing thoughts and behaviors of everyone within an organization by maximizing safety and minimizing risks. 

Aug 18, 2015

ISO 9001:2015 – The Best Thing for Top Management Since Ambien

Are you a sleepless manager? Maybe you'd 
benefit from a review of the changes in the 
new version of ISO 9001:2015.
by Matt Leiphart
Cavendish Scott, Inc.

Reprinted with permission

The best top management sleep aid ever invented may be ISO 9001:2015. I’m not talking about the text, which induces Droopy Eyelid Syndrome. The biggest changes in the new version of ISO 9001 are designed to address top management’s concerns BEFORE problems arise. When systems are in place to prevent problems, top managers feel safe, secure, cared for, nurtured, and they sleep like babies.

Aug 12, 2015

Reimbursement: A Medical Device Company's Worst Nightmare?

Are you losing sleep over the ACA's 
 value-based reimbursement model, too? 

by Lisa Weeks, Marketing Communications Specialist, MasterControl


In 2014, reimbursement trumped regulatory as the industry’s biggest concern.1 As we move further into 2015, it remains at the forefront of stakeholders’ minds. In its 2015 Medical Device Industry Survey, Emergo asked 636 presidents, CEOs and managing directors of medical device companies what issues were keeping them up at night, and reimbursement challenges ranked in the top three.2 In this era of health care reform, device makers are under intense pressure to develop products that demonstrate not only clinical efficacy, but also real value (i.e., lower costs and better outcomes) in order to secure coverage and attract risk-averse investors. In this post, we’ll examine some of the most common reimbursement policy challenges and discuss strategies for putting them to rest. 

Aug 11, 2015

Unique Device Identification (UDI): Much More Than Just a Label


Unique device identification (UDI) will not only change 
the face of your med device labels, but it will 
also affect processes spanning your entire operation.


by Beth Pedersen, Marketing Communications Specialist, MasterControl

Labels are everywhere. Virtually every manufactured item is labeled with product information, and even fresh produce from the grocery store often bears a scannable barcode and ID number. Not only are things labeled, but people, too – any visit to the hospital comes with a bracelet displaying your personal medical details, identification information and a barcode. For the most part, we have become so desensitized to barcodes and labeling information that we rarely pay it any attention; presented in the form of random lines and number series, it can seem completely meaningless to us.

Aug 6, 2015

Why a Zombie Apocalypse Would Be Unstoppable with a QMS


Would zombies be more successful 
at world domination if they used an 
electronic quality management system?

by Marci Crane

Localization Manager, MasterControl



Of the myriad ways in which the Earth’s inhabitants could potentially be destroyed, a zombie apocalypse (ZA) is undoubtedly one of the least impressive. Though a ZA is decidedly scary, unpleasant, and would “get the job done” as the un-romantic expression goes, it tends to lack the qualities and traits that truly cataclysmic destruction requires. These destructive qualities include intelligence, charisma and the ability to organize as a group.

Aug 4, 2015

What Quality Really Means: Three Key Principles


by Lane Hirning
Product Management Director,
MasterControl Inc.

A friend of mine recently asked me to review his PowerPoint presentation for an upcoming investor conference, which I was happy to do. The first thing that struck me was his choice of fonts—different types and different colors. Second was the slide templates creating an inconsistent layout. It seemed like a trivial thing to point out, but I had to ask him: What kind of a first impression are you going to make with this presentation?

As a member of the product management team for a software provider that caters to regulated industries, I’m keenly aware of the importance of quality and how it impacts our customers. If you are a quality professional yourself, or if you belong to a regulated industry, then you’ll understand when I say that for us, quality is a way of life. It’s not something like a hat, which you put on in the morning before you leave the house and then take off in the evening when you come home.

Jul 30, 2015

My eQMS Consultant is Gone—Now What? 4 Post Go-Live Survival Tips


As users begin to learn the software, they will 
have lots of questions. Will you be ready?  
by Stephanie Jones, Senior Professional Services Consultant, MasterControl

In my April 9, 2015 post, I offered eight tips for planning a seamless software go-live. This post picks up where that one left off to answer an important question many clients wrestle with after a successful go-live: What do you do when your software implementation consultant is no longer part of your day to day operations?

Having participated in hundreds of software implementations, as both a user and a consultant, I have found that so much focus is placed on getting through the actual go-live process that customers often forget there’s one final implementation hurdle to clear: incorporating the application into their daily business activities.

If you’ve recently completed a successful software go-live, congratulations! You probably think you can relax and go back to your real job. Sorry—but that’s just wishful thinking.