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Dec 31, 2015

Big Changes for ICH GCP & EU Regulations

Changes are being proposed for international 
clinical research, including the European Union.  
How and when will they affect your work?


by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants


What GCP changes are being proposed for international clinical research?

How and when will they affect you?

Dec 29, 2015

5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

Effective risk management requires an 
in-depth and sometimes painfully honest assessment 
of your processes and your areas of risk. 
by Lillian Erickson
Global Quality Manager, MasterControl Inc.

The publication of ISO 9001:2015 in September generated much anxiety among companies fearing a bumpy transition to the new and significantly changed international standard. Admittedly, we at MasterControl were not immune to those worries.

Despite having quality experts involved with the ISO changes since they were proposed some years ago, even we did not know how our ISO assessors would apply the new requirements, what evidence they would expect to see, and how to pre-emptively satisfy their expectations.

Additionally, MasterControl is not a typical manufacturer of materials, but rather of software and services. This means we needed to understand the intent of each requirement under the new standard in order to correctly apply them to our products and services.
After much research and preparation, we’re proud of the fact that when we completed the audit successfully on Nov. 12, 2015, no other company in the world had yet received a certificate for the new ISO 9001:2015 standard (1), though a few held audits the same week we did. In fact, it was only that very week that ISO assessors across the globe were authorized by their governing bodies to begin certifying companies to the revised standard.
Some people have asked me what I learned from the audit experience, as well as the preparation that preceded it. Below are five lessons I learned, but first, a quick background.

Dec 23, 2015

A Season for Giving That Lasts All Year


During the holidays and all year round, a gift
by Beth Pedersen, Marketing Communications Specialist, MasterControl

We all feel it this time of year. As temperatures drop and snowflakes swirl, lights and festive decorations illuminate the long, dark nights, and names are diligently checked off seemingly endless shopping lists, we know that the holiday season is upon us. In spite of the stress that can accompany the holidays – the long lines, the gift wrapping, the social obligations – this time of year marks a widespread urge to give: to family, to friends, even to those we’ve never even met. We all feel it, this intangible, albeit very real, spirit of giving.
For many, the spirit of giving carries over into the workplace. When I look at companies in the pharmaceutical, medical device and blood and biologics industries, I am struck by what seems to be a collective tendency toward philanthropy and (at the risk of sounding cliché) a desire to make the world a better place. I can’t help but wonder if the people employed in these industries share some common trait that compels them to help others, both in their private lives and through what they do for a living. Although social responsibility is a year-round endeavor for many organizations, I thought it appropriate to take a moment during the holiday season to highlight one such company and its culture of giving.

Dec 22, 2015

Using Quality by Design to Improve Manufacturing

Process control and process improvement 
are important parts of life cycle management.


by Ronald D. Snee, PhD

Snee Associates, LLC                                                                                                       


Much of the literature on quality by design (QbD) has focused on the creation of the “Design Space” (ICH 2009) which is the combination of levels of the critical process parameters that produces in-specification product. Design space creation is critical but a process control strategy is also essential and is an integral part of QbD. Stage 3 of  the FDA Process Validation Guidance calls for “Continued Process Verification” (CPV),  or continually verifying the process is doing what it is supposed to do throughout the life of the product (FDA 2011, Snee 2015). Also if we are to be effective in using life cycle management to manage the process over time. we must have a process management system in place that integrates both process control and process improvement (Snee and Gardner 2008, Snee 2010b).

The focus on QbD places an even greater emphasis on the quality of pharmaceutical products and manufacturing process performance. Indeed process and product control is a major building block of QbD (Snee 2009). A systematic approach to achieve this objective is described below.  Improved manufacturing performance and reduced costs are a natural byproduct of the system.

Dec 17, 2015

Preparing for ISO 13485:2016 Changes

by James Jardine, Marketing Communications, MasterControl


As 2015 comes to a close, medical device manufacturers throughout the world share one collective concern: how will the ISO 13485:2016 revision compare with other versions of the standard? In a new three-part video series, Walt Murray, MasterControl’s director of Quality and Compliance Consulting (QCC) services, walks through what, why, when and how changes are coming to the standard.

The first video in the series is available here.

Dec 15, 2015

6 Lessons that Quality Managers Can Learn from ‘Star Wars’

by David R. Butcher

Marketing Communications, MasterControl


Beginning with A New Hope nearly 40 years ago, characters in the epic Star Wars saga have offered many lessons that may prove valuable for even the most seasoned quality managers. There are numerous examples of positive behaviors that managers might consider emulating in their daily work and behaviors that should always be avoided.

With the seventh installment in the film franchise arriving in theaters on Dec. 18, here we revisit the series and highlight six lessons that quality managers can learn from a galaxy far, far away.

Dec 9, 2015

The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most 
complex pharma track and trace law ever passed.

by David Dills

Sr. Consultant, Regulatory & Compliance, Devices

NovusLife


On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013  (DQSA) into law, bringing a successful conclusion to efforts by the industry and consumer groups to create a national pharmaceutical serialization and track and trace regulation, one that eliminated the patchwork of state laws in addition to providing new regulations for compounding pharmacies.  This is the most complex pharma track and trace law ever passed.

The Drug Supply Chain Security Act (DSCSA), which is Title II of the DQSA, is the most complex pharma track and trace law every enacted.  Its many layers of complicated rules and regulations provide challenges that companies will need to untangle indeed. 

Dec 7, 2015

How Performance Excellence Helps Broaden the Horizons of Quality



Where is your focus---on the quality of business or the business of quality?

by Mickey Garcia, Segment Manager, Medical Devices, MasterControl


Since W. Edwards Deming’s pioneering work in the 1950s, we have witnessed remarkable progress in the disciplines of both quality and management. Through the years, the best practices of the day have been given fancy names such as total quality management (TQM), Six Sigma and, most recently, Lean everything—just to name a few. With so many hifalutin terms being bandied about, it would be easy to dismiss an emerging term like performance excellence as just another buzzword. But there’s a case to be made for incorporating it more fully into our quality-related vocabulary: to help us, as Dr. Mikel Harry says, look beyond the mere business of quality and focus increasingly on the quality of business.

Dec 3, 2015

The Mysterious "No Fault Found"

Ferreting out root cause can explain the 
reasons behind a "no fault found" condition.

by Harish Jose

Senior Quality Assurance Engineer


As a quality engineer working in the medical device field, I find there is nothing more frustrating than a “no-fault-found” condition on a product complaint. The product is returned by the customer due to a problem while in use, and the manufacturer cannot replicate the problem. This is commonly referred to as no-fault-found (NFF). I could not find a definite rate on NFF for medical devices. However, I did find that for the avionics industry it is 40 percent to 60 percent of all the complaints.

The NFF can be also described as “cannot duplicate,” “trouble not identified,” “met all specifications,” “no trouble found,” or “retest ok.” This menacing condition can be quite bothersome for the customer as well as the manufacturer. In this post, I will define some red flags that one should watch out for and provide a list of root causes that might explain the reasons behind the NFF condition. I will finish off with a great story from the field.

Dec 1, 2015

Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

An auditor's goal is to confirm the trial runs 
in a way that ensures the safety of the subjects, 
protects their rights and generates reliable data.

by Jessica Masarek

Quality Assurance Consultant | Independent Auditor

Director, Muse Clinical 



Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen.  What if I say the wrong thing?  What if I don’t know the answer?  What if I can’t provide what they are asking for?  Realistically, all of these things will probably happen!  That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection.  We are expecting transparency.  As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data.  Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted.  An inspector has a similar goal with respect to the assessment of trial conduct.  So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?

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
MasterControl


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

NovusLife


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

info@compassassurance.com.au



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, 
MasterControl


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.

Oct 22, 2015

6 Traits You Should Develop to Become an Exceptional Quality Pro

by Cindy Fazzi

Editor, MasterControl Insider


 In a regulated company, quality professionals may be revered or dreaded or downright misunderstood. But there’s no denying their important role. As quality guru Joseph Juran said, all improvement happens project by project and in no other way. To paraphrase Juran, I would say a high-quality product or service happens step by step and process by process. Guess who’s responsible for making sure every step and every process is working effectively? You got that right—quality pros.

Oct 21, 2015

MasterControl to Serve as QMS Provider for Another FDA Division

The FDA’s CDER is responsible for ensuring drug 
safety and effectiveness in the United States.

by Cindy Fazzi
Editor, MasterControl Insider

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) is known worldwide as the office that approves innovative drugs, namely new molecular entities and new therapeutic biologics. Every year, the news media reports the number of novel drugs approved by CDER and the global impact of those medicines. But the center’s mission is much more than that. It ensures drug safety in the United States by regulating over-the-counter and prescription drugs, including biological therapeutics and generic drugs, and even such things as fluoride toothpaste and sunscreens (1).

MasterControl has announced that the company and its partner, i4DM, will serve as quality management system (QMS) providers for CDER’s Division of Pharmaceutical Analysis (DPA). The two companies are also the QMS providers for the FDA’s Office of Regulatory Affairs (ORA).

Oct 20, 2015

FSMA: Get Inspection-Ready with These Best Practices

by Melanie J. Neumann, J.D., M.S.

Executive Vice President

The Acheson Group


Although FDA immediately gained increased authority for records access upon the signing of the Food Safety Modernization Act (FSMA) in January 2011, some companies haven’t gotten the memo yet.  

The following best practices will help food and beverage manufacturing facilities get inspection ready and offer guidance on how to push back if overreaching occurs.

Oct 19, 2015

Trust is Not Just Nice, It’s the Key to Your Success


Best-selling author Stephen M.R. Covey gave 
a business case for trust in his keynote speech 
at the 2015 Masters Summit in Salt Lake City.

by Cindy Fazzi 

Editor, MasterControl Insider


Whether you’re a quality professional responsible for your system implementation or a CEO getting ready to launch a medical device startup, Stephen M.R. Covey believes there’s one thing you need to succeed—trust. “Trust is an economic driver, not merely a social virtue,” he said in his keynote address at the 2015 Masters Summit.

Everyone needs to be time- and cost-efficient. Trust will help you achieve both, according to Covey.  “Nothing is as fast as the speed of trust,” he said. “The economics of trust covers speed and cost. When trust goes down, you will feel your speed go down, and consequently, cost goes up.” He called that extra cost the “trust tax.”

Oct 15, 2015

Personal PDCA and How I Learned It

Have you applied PDCA to 
your self-development plan?
by Mark Reich
Chief Operations Office
Lean Enterprise Institute



In 23 years at Toyota, I had many assignments and different bosses, I managed many people, but a constant part of the culture was what I’ve come to call “personal PDCA” – a kind of mentored self-development cycle. When it comes to personal PDCA, my first problem solving experience during my first-ever assignment in Japan stands out for me.

On my first day at the office (in 1988), I was assigned both a mentor and a problem to solve. The organization I worked in was responsible for new model planning for global overseas markets – design input, grades, and specifications for Camrys, Corollas, and many other models headed to the U.S., Europe, other areas in Asia, the whole world. And within that Department, my group was responsible for Competitive Analysis. When planning a new Camry for example, we studied what Honda was doing with its new Accord along with all other competitors in that market.

Oct 13, 2015

How Scary are the Device Safety Requirements in IEC 60601-1 Edition 3.1?



Yikes! Amendment 1 introduces over 20 new 
requirements and 60 modifications.
by Lisa Weeks, 
Marketing Communications, MasterControl   

Few things are more frightening to an overwhelmed and under-resourced medical device manufacturer than a change to a regulatory standard, particularly if it’s a big one. (Cue creepy music.) Such is the case with IEC 60601-1 Edition 3.1, the internationally recognized standard that addresses the general requirements for medical electrical equipment and devices. Amendment 1, which was introduced in 2012, contains more than 250 changes to the text of the standard, many of which significantly alter the standard’s meaning and/or intent. Scary, right? Even scarier, the FDA will begin enforcing the new requirements as early as August 2016. Yikes!

Oct 8, 2015

Risk Takes Center Stage in ISO 9001: 2015


Explicit references to risk appear 
throughout ISO 9001: 2015.

by Lisa Weeks, Marketing Communications, MasterControl

If you’re unfamiliar with the concept of risk, or your exposure to it has been limited, now is the time to get comfortable with all aspects of risk as it relates to the quality management system. Why? Because the latest edition of the standard makes risk management, which has always been implicit, explicit. In other words, it’s no longer optional; it’s a must.
In this final installment of a three-part webinar series, ISO experts Walt Murray and Peter Knauer discuss (among other things) the four phases of risk management, where risk is documented in the new standard (hint—almost everywhere) and how to relate the objectives of your quality system to risk (this is key!). Get a head start on the transition process by watching this free webinar now. 

Oct 6, 2015

Quality Audit: The Direct Route to Continuous Improvement


When it comes to public health and safety, 
quality is the only way.
by Beth Pedersen, Marketing Communications Specialist 
MasterControl

If your organization is GxP-regulated or ISO-certified, you are no stranger to the burdens of audit. The regulations and standards that govern your operations change often, and yet you must somehow manage to understand and comply with them – and be able to clearly demonstrate your compliance – at all times.

In the flurry of keeping pace with changing regulatory demands and preparing for impending audits, you might lose sight of the value an audit can bring to your organization. It comes down to a simple yet very important question: if you don’t observe and evaluate, how can you improve?

Audit is a powerful word that seldom invokes positive associations. An audit – by its nature and in any context -- can uncover problems, and problems can warrant penalties, sometimes very serious and costly ones. The headaches involved with preparing for an audit include managing a vast amount of documents, gathering evidence, collecting signatures and signoffs, training employees, coordinating stakeholders, and the list goes on and on.

Oct 1, 2015

EDMS Evolution: Automated Document Management as a Differentiator


Thirty years ago, only the most elite, cutting-edge manufacturers had electronic document management systems. But 30 years ago we also had cassette players in our cars, memberships to Blockbuster video, and spare change for payphones. Over the past three decades, electronic document management systems (EDMS) have had the same “creative disruption” effect on manufacturers that streaming television services, online booksellers, tax software, and travel websites have had on the rest of the economic landscape.

In fact, companies in industries in which paper-based document management systems have historically proliferated are now spending more money on automating document control than on any other quality management process. A multi-year survey by LNS Research shows that 48 percent of survey responders now have an EDMS. What’s more, EDMS was the leading vote-getter of all the quality management processes that companies are starting to automate.[1] That 48 percent response rate represents more than twice as many manufacturers than have purchased software to automate audit management (25 percent) and compliance management (20 percent) processes combined, according to the same study.

Sep 30, 2015

MFG DAY 2015: U.S. Manufacturing at a Glance

In preparation for Manufacturing Day 2015,
U.S. manufacturing facts and figures

by David R. Butcher, Marketing Communications, MasterControl

In recent years, a swing in public perception has led to widely held misconceptions of United States manufacturing – that modern manufacturing environments are dark, dangerous and antiquated factories designed for low-skilled workers.

On Manufacturing Day (MFG DAY) 2015, this Friday, manufacturers all across the U.S. will open their doors in a coordinated effort to correct this public perception by showcasing modern manufacturing as it really is today: technologically advanced, using sophisticated automation, robots and 3-D printing, and employed by highly trained professionals.

Sep 29, 2015

What Do You Do? A Short and a Long Answer


MasterControl helps regulated companies 
adopt a closed-loop quality management 
system (QMS) that greatly accelerates their 
compliance and reduces their compliance costs.

by Jon Beckstrand CEO, MasterControl


I was recently asked point-blank: What does MasterControl do? I was being interviewed for a medical device publication’s podcast, so the question was expected. Still, it forced me to mull over the company’s mission and accomplishments in the past 13 years under my leadership.

The short answer to the question is we provide quality management software to life science and other regulated companies. The long, more meaningful answer is much more than that. Our mission is to help our customers make their great products—many of them life-saving products—available to more people sooner at a lower cost and at a much higher quality. For example, we’ve helped a medical device company reduce its change control process from 60 days to six. Shorter processes as a whole means getting the device to market sooner, which in turn means sparing patients from unnecessary waiting.