Nov 25, 2015

How ISO 9001:2015 May Preview Upcoming ISO 13485 Changes

ISO 9001:2015 can help medical device 
companies anticipate forthcoming 
ISO 13485 changes.

by David R. Butcher

Marketing Communications, MasterControl

This fall, the International Organization for Standardization (ISO) published ISO 9001:2015, the updated quality management system (QMS) standard that now follows a new, higher-level structure and includes a number of other key changes that regulated companies have three years to meet.

We’ve already delved into how the changes directly affect a wide range of manufacturing organizations  including adoption of the Annex SL high-level structure framework and increased leadership requirements  and what these regulated organizations can do to ease the transition. However, the revisions also have implications for other standards, including ISO 13485, which is often harmonized with ISO 9001.

For medical device companies, the publication of ISO 9001:2015 offers something of a preview of forthcoming revisions to ISO 13485, which outlines QMS requirements for medical devices.

Nov 23, 2015

Holistic CQMS: The Modern Model of Clinical Trial Management

Best clinical quality management practices 
can only be achieved when an overarching
 culture of quality exists organization-wide.
by James Jardine, Marketing Communications, MasterControl Inc. 

The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.

Quality and compliance are taking the reins to a greater extent than ever before as the driving forces behind the efficiency and profitability of any organization undertaking a clinical trial. This point was recently illustrated in an informative article by Patricia Santos-Serrao[1], a veteran regulatory and clinical expert and member of the Drug Information Association (DIA) and Regulatory Affairs Professional Society (RAPS). “The core aspects of quality – including training, document management, risk mitigation and quality management – can be used to provide efficiencies and improve quality of data throughout the clinical trial process,” Santos-Serrao says in the article. “Quality assurance, quality control and risk management are not simply for manufacturing.”

Nov 19, 2015

9 Crazy Cousins You Probably Shouldn’t Invite to This Year’s Thanksgiving Dinner and 9 Reasons You Could Invite SCORM (Compliance) Instead

Consider trading SCORM for the crazy 
cousins at this year's Thanksgiving feast.

by Marci Crane
Localization Manager

Thanksgiving in the USA is a wonderful time of year when we are reminded of everything that we have and how lucky we are to have it. We express our gratitude for what we have, where we live and those we love. 

Despite all the gratitude we feel, however, there is a certain reluctance to share the holiday of thanks with certain so-called relatives we know, deep down, can’t really be related to us because they are….well…CRAZY.

Even if there’s an empty seat left at the Thanksgiving table because you didn’t invite Carol, Jake or Johnny, just remember that SCORM (as in SCORM compliance) will feel exactly like a member of the family.

Here are some of those crazy cousins you might want to encourage to have their own Thanksgiving dinner this year. After all, you’ll need to make room at the table for SCORM.

Nov 17, 2015

The Future of Medical Device Registries

 The FDA believes that national and international device 
registries in selected product areas are the foundation of 
our National Medical Device Postmarket Surveillance System.

by David R. Dills

Sr. Consultant, Regulatory & Compliance, Devices


A registry is broadly defined as a collection of information about individuals, usually focused around a specific diagnosis, condition, or intervention.  Individuals may provide information about themselves to a registry on a voluntary basis, either directly or through their physicians.  A registry can be sponsored by a government agency, nonprofit organization, health care facility, or private company, and over time can provide researchers and other health care delivery stakeholders with first-hand information about patients, both individually and as a group, which can increase our understanding of that condition.  This post places key emphasis on medical device registries and why this topic is becoming increasingly important with FDA and our device manufacturers.

Nov 12, 2015

eTMF Management: Don’t Settle for a One-Trick Pony!

When you search for an electronic 
master file (eTMF)  solution, be sure it 
is versatile and not a one-trick pony!

by Patricia Santos-Serrao 

MasterControl's Market Segment Manager

Global Pharmaceutical, Blood & Biologics

Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement.  With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

Nov 11, 2015

6 Military Skills Highly Valuable to Manufacturers

This Veterans Day, employers should 
consider the valuable skills and attributes
typically shared by most U.S. military vets.
by David R. Butcher, 
Marketing Communications, MasterControl

Following years of high unemployment, the hiring outlook for service members transitioning into the civilian labor force is improving. The unemployment rate for veterans from all branches of the military is now just 3.9 percent, compared with 4.5 percent a year ago and a current national unemployment rate for all Americans of 5 percent, according to the U.S. Bureau of Labor Statistics last week.

Indeed, there is growing evidence that companies are actively recruiting veteran talent to shore up their headcount, with science, technology, engineering and math (STEM) jobs representing the most common job areas for veteran recruitment.

Nov 10, 2015

Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

ISO certification may be challenging 
to attain but offers many benefits.

by Stuart Patch 

Content Writer, Compass Assurance Services

There are many benefits for organisations gaining certification and for those organisations that are currently certified, ensuring those benefits continue to be realised is very important. Below I look at the benefits of certification and also what are the benefits of keeping abreast of upcoming changes in standards.

Nov 5, 2015

Training Effectiveness – A Quality by Design Approach

You can provide all kinds of training 
for your employees but how do 
you measure its effectiveness?

By Holly DeIaco-Smith, MS 

HDS Consulting

In the role of a consultant, you have the benefit of seeing what works well across your client base and their shared common pain points. Because of this perspective, I’m often invited onto a project to provide guidance on best practices and practical advice on how to avoid the common pain points. 

As a case in point, recently a client asked me, “What’s the best practice for training effectiveness?” My response, in typical consultant fashion was, “How are you defining training effectiveness?” Their response was, “We’re not sure, but we were cited for it in a number of client audits.”

Nov 3, 2015

How Donald Trump and/or Hillary Clinton Would “CAPA the USA” if Elected in 2016

Trump and Clinton: "CAPA'ing" the USA

by Marci Crane
Marketing Communications, 

Although a long list of candidates make up the list of “eligibles” for the 2016 Presidential election, it’s fairly apparent that the two most conspicuous candidates are, respectively, Democrat Hillary Clinton and Republican Donald Trump. These two candidates, though liked and disliked by various population pockets across the United States, have certainly managed to make names for themselves within their various areas of expertise. 

A Little Fun with Hillary and Donald and the Power of the CAPA Process
This article is meant to be a satire…not offensive in any way but certainly a bit funny and who better to help us out than Hillary and Donald? However, despite its satirical status, this article is serious about the power of the CAPA process, which has been proven to repair errors, prevent those same errors from reoccurring and improve the quality and efficiency of essential processes.

Oct 29, 2015

Streamlining CAPA Processes: Manual Systems vs. Automated Solutions

by James Jardine, Marketing Communications, MasterControl

The real challenge in managing corrective and preventive actions (CAPA) isn’t knowing whether or not you’re making the right decision or the wrong decision. It is understanding if you’re making smarter and better decisions. There are any number of ways a manufacturer can handle a quality event, but what is most crucial is that the organization is in the best possible position to effectively deal with that event.

Effective CAPA management isn’t about making the right decisions, it’s about
how thosedecisions are made. How efficient are your CAPA processes?

Take your company’s customer complaint handling process, for example. How is your organization prepared to handle a customer complaint about a product that warrants the initiation of a CAPA? From a customer perspective, the solution should be as simple as finding the source of the problem and fixing the issue. In your actual experience, however, the overall process is much more complex and demanding. There are a number of complicated steps that need to be taken when correcting problematic issues and preventing their recurrence. How these steps are managed—and how efficiently they are handled—differs dramatically between manual (paper-based or paper/electronic hybrid) systems and automated CAPA systems.

Oct 28, 2015

10 Halloween Costumes that Will Inspire Quality Professionals to Communicate Even More Effectively with Their Executives

by Marci Crane
Marketing Communications, MasterControl

Employment pundits say in today’s job market, it’s not enough to have skills and education. Today’s top employees must “dress for success.”  What better time is there than the end of October to consider a bit of dress up?

Considering what character or idea you’re going to “play out” on the night of October 31st can really get your creative juices flowing. This characterization may even inspire the way you communicate with other employees…..especially when those “others” are the executives who make the major decisions that influence your company/organization.

So, without further ado, here are the top 10 costumes recommended for quality professionals this season.

Oct 27, 2015

Still Using Paper for Audits? Here’s Why You Need to Automate

A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.

Although these are high-tech industries, the control and regulation of day-to-day processes is still being done manually—and any manual process has weaknesses. When considering the benefits that can be achieved by automating auditing processes, it’s hard to see why more life science companies aren’t looking at what automated systems have to offer. Let’s take a closer look at just a few of the benefits automated audit processes can bring.