Jan 12, 2017

5 Tips for Bolstering Cybersecurity

Balancing patient data security 
and convenient access is possible

by David Jensen

Marketing Communications


Cybersecurity can be exhausting and difficult to control—even for IT pros. A security risk management executive at AbbVie Inc., discussed cybersecurity at the 2016 PDA/FDA Joint Regulatory Conference and offered some tips for how you can ramp up your organization’s IT security efforts.

Jan 10, 2017

5 Things I Learned about FDA Audits from its Sister in Compliance, the FCC

The unannounced FDA audit is a feared 
experience but these five tips can alleviate 
some of the stress.

by Anthony Rossi

Sales Operations Specialist


Before I came to work at MasterControl, I was an operations coordinator at a company called CaptionCall. CaptionCall provided telephone captioning to the hard of hearing, and because it was funded through federal taxes we were directly overseen by the FCC. While I was working at CaptionCall, I was directly involved in an audit performed by the FCC. The day of the inspection was one of the most stressful days in my career.

Jan 5, 2017

5 CAPA Best Practices You Should Be Doing Now

Clinical research pros can learn 
from manufacturing when it 
comes to leveraging CAPA.

by Cindy Fazzi

Editor, MasterControl Insider

Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and should leverage CAPA principles in clinical research.

“If you work in clinical research, you can use CAPA strategies that have been tried and tested in manufacturing and adopt them for your specific needs. The CAPA framework for investigating a quality issue is applicable in clinical as much as another area,” said Santos-Serrao, MasterControl’s director of clinical and regulatory solutions for the pharmaceutical, blood, and biologics industries. She shared five CAPA best practices that you can adopt in clinical trials in an article she wrote for Pharmaceutical Commerce. 

Jan 3, 2017

How to Minimize Protocol Deviations

Not all protocols are 
well written or error-free.

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc. 

Year in and year out, protocol deviations are the most common FDA site inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.


Dec 29, 2016

Protect Your Investments!

Preventive equipment maintenance
and accurate documentation of this activity
are important parts of FDA compliance.

by Dr. Christopher Joseph Devine


Devine Guidance International

Failure to maintain and inspect equipment can get a device establishment into big trouble.

This article first appeared in the August 31, 2016 edition of MedTech Intelligence.  Reprinted with author's permission.

Did you miss old doctor? Dr. D is back from a two-week hiatus that included some drinkin’ and thinkin’, and is again ready to continue with the dispensing of guidance for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements has always been one Dr. D’s salient goals, along with providing a few chuckles. Besides, there is no better forum than one that allows the readers to laugh and learn at the same time.

Dec 27, 2016

5 Ways Artificial Intelligence Is Changing Health Care and What It Means for Quality Management

Artificial intelligence is the future of
health care, and the future is here.

by Beth Pedersen

Marketing Communications


Health care data is expected to reach a staggering 2,300 exabytes (one exabyte is equal to one billion gigabytes) in 2020. We all know knowledge is power, but the amount and complexity of data in existence has long since outpaced the human mind’s ability to access and process it. Enter artificial intelligence (AI). Since its inception over half a century ago, AI has experienced an ebb and flow of attention, investment, development and scrutiny but one idea persists: the promise of making human lives significantly better.

Dec 22, 2016

3 Principles You Must Adopt to Keep Pace With Future Trends in QA

by David Jensen

Marketing Communications


It’s impossible to know what the future holds, but a Bristol Myers Squibb executive shared some insights at the recently held PDA/FDA Joint Regulatory Conference to help you compete better in the future.

Donna Gulbrinski, senior vice president at Bristol Myers Squibb, talked about quality assurance at the conference held in Washington, D.C., from Sept. 12-14. She identified some strategies for how your quality management practices should function going forward. 

Dec 21, 2016

Love it or Hate it, the 21st Century Cures Act is a Big Step Forward

The 21st Century Cures Act is an
ambitious initiative that deserves
public support.
by Cindy Fazzi

Editor, MasterControl Insider

The 21st Century Cures Act is a massive piece of legislation (996 pages) with an equally tremendous ambition. The life science industry heralded it as a victory, while critics expressed some concerns. Everyone agrees, however, that there’s a need to support medical innovation and advance regulatory compliance. The reform-minded law unites all sides to that extent.

The legislation is estimated to cost $6.3 billion upon implementation (1). Signed into law by President Obama on Dec. 13, it generated buzz primarily for Vice President Joe Biden’s Cancer Moonshot initiative, which will receive $1.8 billion in funding under the act, and for providing $1 billion over two years in the fight against opioid abuse.

Dec 20, 2016

Santa Claus Is REAL but He Requires an EQMS!

by Marci Crane

Localization Manager


Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.

Parents can be such miserable wet blankets.

Let’s not wax too dramatic, however. Of course you’ve moved on with your life, and frankly you’ve been a great success, but perhaps---just maybe---some small childlike part of you is still mourning the loss of Santa-Claus-like innocence, wonder, and joy. After all, believing in Santa Claus allows people to enjoy the very act of BELIEVING, which can be fun! In fact, aren’t there times when you wonder if no longer believing in Santa Claus has blocked your ability to believe in the possibility of……well…. everything?

Dec 15, 2016

Lean Thinking: A Roundup

Lean thinking is a better way of organizing, 
managing and thinking about enterprises.

by Tom Ehrenfeld

The Lean Post

Editor's Note:  This article ran first on September 27, 2016 in The Lean Post. It is reprinted with permission.

This month marks the 20th anniversary of the publication of Lean Thinking, the book that helped popularize what many of us today know as “lean.” Over the next two days on the Lean Post, authors Jim Womack and Dan Jones will discuss how their thinking has evolved since its publication. Keeping in spirit with past roundups of other lean topics, here’s a recap of the book, as well as a look at several resources giving context to this thing called lean.

Dec 13, 2016

Rogue Documents: A Standard Story

Failing to maintain control over critical 
documents -- say, blueprints of a moon- 
sized space station -- can be devastating.

by David R. Butcher

Marketing Communications


When Rogue One: A Star Wars Story arrives in theaters this week, audiences will finally learn how the Rebel Alliance got their hands on the Death Star plans, an event referenced in the opening crawl of the original 1977 film. The space station schematics were central to the plot of A New Hope, ultimately enabling the Rebellion to uncover the key weakness that Luke Skywalker exploited to destroy the Empire's ultimate weapon. 

For the Empire, failing to secure its critical information – the Death Star plans – was catastrophic. For an organization working in a regulated environment, failing to maintain control over all of its critical documents and data can also be devastating.

Dec 8, 2016

Top 8 Ways to Reach Regulatory Compliance

Companies that live in regulatory 
environments have come to 
understand that compliance is
 actually a tool that can give
 them a competitive advantage.

by Matt Lowe

Executive Vice President


Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

Instead of kicking against regulations, smart companies embrace them and – like a judo expert – leverage their weight to find success. An organization that is more efficient in achieving and maintaining compliance can get a high quality product to market faster than its competitors.