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.

Dec 6, 2016

CLIA-phites vs. Quality-noids: Who Will Win the LDT Debate?

Can't we all get along? The fight for 
regulatory oversight of lab developed tests 
is far from over.

by Lisa Weeks

Marketing Communications Specialist


The FDA’s proposed guidance for laboratory developed tests (LDTs) continues to create conflict between Quality-noids, those in favor of greater FDA oversight, and CLIA-phites, those who are not. Historically, the FDA has exerted little oversight of LDTs (e.g., no premarket review or quality system requirements) but that’s changing, largely because today’s LDTs are far more complex than the LDTs of the past. Both sides agree that more oversight is needed. Which federal agency should provide it, however, has sparked intense controversy.

Dec 1, 2016

Better IT Tools Mean Better Results

IT, through their choice of employee tools, 
plays a  critical role in the retention and 
motivation of the workforce. 

by David Cornwell


PleaseTech Ltd

An essential and growing component of the workforce, knowledge workers are those individuals whose primary role is the creation or management of information.  Document collaboration is an increasingly common component of these workers’ daily tasks.  In fact, research conducted for PleaseTech by Osterman Research reveals that during a typical month, knowledge workers create an average of 36 documents on which they will need to collaborate with others, while also being asked to collaborate on a further 34 documents. That total of 70 documents a month equates to an average of more than three documents a day.