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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.