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.