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Mar 26, 2014

Changing Supplier Controls Requirements


Changing Supplier Controls Requirements

By John E. Lincoln,  J.E. Lincoln and Associates

Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products.  For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others. 

For much of the rest of the world, the European Union provides a major model, with its directives, emerging CGMPs,  and the ISO quality standards -- ISO 9001 for the majority of quality management systems, and ISO 13485 for medical device QMS. 

All these regulatory requirements mandate that a company establish a ‘total quality system,’ from customer requirements through development, procurement (supplier control), production, to customer use and feedback.   

Mar 25, 2014

Taking Effective Actions: CAPA Webinar Part 2

By James Jardine, Marketing Communications, MasterControl Inc.

Taking Effective Actions: CAPA Webinar Part 2In the second webinar of a three-part series from MasterControl, quality expert Ken Peterson demonstrates how companies can develop better corrective and preventive actions (CAPA) to ensure quality and compliance. In the second installment, Peterson focuses on key decision points and the types of actions that should be taken depending on the quality event. He points out the importance of containing issues at the department level, if possible, before moving them into a formal CAPA process. Peterson discusses four possible actions to be taken when dealing with quality events: no action (the “wait and see” approach), corrections (with a focus on the immediate situation or containment), corrective actions, and preventive actions (to preemptively deter issues from occurring in the future). 


Mar 20, 2014

An Introduction to Metrics Collection and Usage


By Christopher Ball, Senior Professional Services Consultant, MasterControl Inc.

An Introduction to Metrics Collection and Usage
Most companies understand that the collection of data can be valuable but often don’t really rationalize what they want to collect.  Why collect data for “A” rather than data for “B”? Wouldn’t it be better to collect it all?
The problem is there is so much data available, much of it with an automatic collection option, that it’s easy to accumulate it.  The downside of blindly taking this approach is data saturation.  There’s so much to look at that nothing is done to analyze it.  Because the data isn’t analyzed, no action is taken based on the findings.  Effectively, the company drowns in data at best or worse still, makes random and or variable assumptions about the interpretation of the data. As a result, the company could make flawed and maybe fatal business decisions because “the data indicated …..”
The intention of this article it to put some simple steps into the armory of your business so that you won’t waste valuable resources collecting data you won’t use, need, or want.  Instead, collect data that fits with your business direction and strategy---data you can analyze appropriately and use to make balanced informed decisions.  You’ll see that having data and analysis that business management can trust has value.

Mar 18, 2014

Making the Business Case for Implementing an Electronic QMS

Making the Business Case for Implementing an Electronic QMS

By: Lisa Weeks, MasterControl Inc., Marketing Communications 

In a tough economy, quality professions often find themselves having to convince management that swapping their paper-based QMS for an electronic one is worthy of the expense and will translate into bottom-line, as well as compliance, benefits. While the regulatory and legal drivers for automating your quality processes are irrefutable, the frequently overlooked operational and business opportunities enjoyed by organizations that implement an electronic QMS are equally compelling. Simply put: compliance is good for business, and the right QMS software can help you transform your compliance challenges into tangible business advantages. 

Study Shows QMS Software Has Become a Top Priority in Best-in-Class Companies

QMS software is becoming commonplace in best-in-class organizations. According to AMR Research, quality management has moved from an afterthought to a strategic priority, topping the list as the most important software component in supply chain risk visibility. (1) What’s prompting the increased demand? No doubt it’s the intense and mounting scrutiny from the FDA, EMA, ISO, and other global regulatory agencies. But regulatory pressure isn’t the only thing keeping CEOs, CFO, and other senior executives up at night. Here are some commercial advantages to automating your quality processes, such as document controlemployee training recordscorrective action, and risk management, that will resonate strongly with senior management and stakeholders. 

Mar 13, 2014

Sound Risk-Based Decision Making in Process Validation

By Robyn Barnes, Marketing Communications, MasterControl Inc.

MasterControl’s Walt Murray recently returned from a speaking engagement at MD&M West.  I asked him for impressions of the conference.
Do you know the difference
between the decision-making process
and root cause investigation?

“The exhibition was massive,” he said.  “It was a great event for us.  There were so many people everywhere you went that it felt like a real crush. I’ve got to tell you that a foot massage every night would have been really useful. “
During the meeting, Walt taught a class on “Conducting the Validation Protocol, Collecting and Analyzing the Data.”  
“Normally, this might not be the most exciting class to attend, especially right after lunch,” he says.  “But we had a full room.  The discussion was lively and ranged from the importance of quality decision-making to solid event management.  I was surprised to discover that many people were not clear on what solid event management means.“ 

Mar 11, 2014

Four Team Members to Include When Building Your Software Implementation Dream Team (and Two to Avoid).

Team Implementation

By Stephanie Jones, Professional Services Consultant, MasterControl Inc. 

According to a study by Gartner Research, nearly four in ten major software purchases end up as “shelfware,” i.e., software that is purchased and never implemented or only marginally configured and/or deployed. Why? Often, it is because of the application itself or the perceived unresponsiveness of the software vendor’s implementation consultants. Rather than compromise efficiency, or redesign proven processes which took years to develop and implement, an organization will opt to delay or abandon a software rollout, resulting in a significant waste of financial and human resources.

But a complex application and/or poor communication on the part of the provider are not the only factors than can halt or completely derail your implementation. While selecting the right application/vendor is critical, and this is true regardless of the application, whether it’s an enterprise resource planning (ERP) solution or a quality management solution (QMS), it’s equally important that the customer organization assign the right people to its internal implementation team.

After nearly 30 years of working with literally hundreds of teams to implement a variety of software applications in highly regulated companies, I have developed a theory about who belongs on the customer’s implementation team—and who doesn’t. First, let’s talk about who doesn’t.

Mar 7, 2014

Food Safety is a Matter of Degree

By Robyn Barnes, Public Relations Specialist, MasterControl Inc.

Global Food Safety Conference 2014 kicked off recently in Anaheim, California with a record-breaking attendance.  It seems that everyone is concerned about the condition of the food they eat, if they have it to eat.

FoodSafetyTech.com reports that during the main address, Jayson Lusk, Professor & Willard Sparks Endowed Chair, Department of Agricultural Economics, University of Oklahoma State, talked about the change in the food system, risk and consumers. He said that food is safer than ever before. I had to chuckle, then, when further down in the same publication I came to Dr. Doug Powell’s blog, Stickit In:  Thermometers, Not Color, Requiredto Cook Safely.” For years, Dr. Powell has promoted cooking meat with thermometers to ensure doneness---and he’s not just referring to home cooks.  Restaurants need to insert measuring sticks, too.  The same goes for grocery stores that prepare food in-house for sale.


Mar 6, 2014

The Bright Future of Quality and Compliance

By Craig Gygi, Executive Vice President, Operations, MasterControl Inc. 

 Quality and compliance stand at a crossroads. It’s the same crossroads that many other professional fields have navigated. Remember when computers entered the mainstream of business?
Only three decades ago, all business computing capability resided in the hands of programming and IT specialists. If you needed any computational or data power to perform your business function, you were referred to the computer department. They queued your request and later dispensed the results—a report or an analysis. The methods and tools of their craft remained mysterious to most. Yet their expertise in the arcane enabled the critical functions of business.
But inevitably the professional specialty of computing, and its clientele, matured: the monolithic hardware-software providers started to have to compete with system integrators who offered tailored, commodity-based solutions; the personal computer began to distribute some computing power—formerly contained only in mainframes—to individuals; graphical user interfaces replaced the command prompt and blinking cursor; and application software began to bridge the gulf between the non-expert user and the mysterious computer infrastructure.

Mar 5, 2014

More Helpful Quality Event Management Tips from MasterControl CAPA Presentation

By James Jardine, Marketing Communications, MasterControl Inc.

A previous post to this blog covered some of the highlights of a recorded MasterControl webinar that discusses best practices for corrective and preventive action (CAPA) systems. The free recording is presented by quality expert Ken Peterson, a prominent consultant who has decades of experience with risk management, customer service, and CAPA systems. Peterson has devoted his quality expertise to a long list of successful companies such as Pfizer, Abbott Laboratories, Kodak, and IBM.



More Helpful Quality Event Management Tips from MasterControl CAPA PresentationIn addition to the information covered in the previous post, the webinar also illustrates how an effective quality management system needs a gateway in order to prevent “death by CAPA.” The main elements of this gateway, impact and frequency, are discussed at length.


Mar 4, 2014

Be SMART: 5 Critical Factors in CAPA

Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.
Cindy Fazzi

By Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.


It’s not enough to come up with a corrective action for a quality event. It’s critical to have the right action that actually fixes the problem and prevents it from recurring.
“The focus of CAPA is to arrive at a solution. And some solutions are better than others,” said Ken Peterson, MasterControl’s director of business development, Quality and Compliance Consulting Team (1).
The February 2014 edition of GxP Lifeline features a free CAPA webinar, in which Peterson explained what “three loops in one” CAPA process means and why it’s critical for regulated companies.