Mar 31, 2015

Why Do You Do What You Do?


Most of MasterControl's customers are highly 
regulated companies that provide important 
products to people throughout the world.
by Jon Beckstrand
CEO, MasterControl Inc.

Have you ever asked yourself why you do what you do? When you find yourself buried in quality procedures and SOPs, or embroiled in a heated meeting over incomplete CAPA tasks, do you ever question the meaning of your work?

Back when MasterControl had only 50 employees, it didn’t occur to me to ask this question. Now that the company is so much bigger and our presence has expanded worldwide, the question has become more relevant.

Mar 26, 2015

3 Keys to Driving Collaborative Growth in Life Sciences


Life science companies are being 
frustrated in their attempts to bring 
higher quality products to market.
by James Jardine
MasterControl



A recent study by LNS Research shows that life sciences companies are facing an unprecedented demand for better and safer products. Results from LNS Research’s surveys of industry executives indicate the pressures life science organizations are facing and the new technologies and processes they are employing to meet rising needs.


There are two paramount “megatrends” compelling life sciences companies to bring higher quality products to market at an accelerated rate:

Mar 24, 2015

Closed-Loop Quality Management: Connecting the Value Chain

Quality management must extend 
beyond the manufacturing environment.
by James Jardine
Marketing Communication, MasterControl

An increasing number of leading organizations are learning that quality management must extend far beyond the manufacturing environment, according to a recent eBook co-sponsored by LNS Research and MasterControl. The research collected in the eBook indicates that market leaders are beginning to implement a closed-loop approach to quality that bi-directionally unites people, processes, and data across the value chain. This approach connects quality from design and procurement stages all the way through manufacturing and service. Other findings in the book show that Enterprise Quality Management Software (EQMS) is vital to the establishment of an effective closed-loop system that can help a manufacturer better control costs, compliance, and risk.

Mar 19, 2015

Did the Titanic Follow ISO 31000 Risk Management Guidelines?

President, E3

ISO 31000 (Risk Management) and its supporting publications encompass an impressive and useful "to-do" list of risk management guidelines to create and protect the value of an organization. However, if an organization selectively pursues some of the ISO guidelines and ignore others, highly undesirable events and tragedies can occur.  This is what happened with the Titanic.

ISO 31000, section 4.2, suggests we align risk management efforts to our objectives. White Star Lines, the Titanic builders, fulfilled this requirement. Their objectives were to create a luxury liner at the lowest costs, in the least amount of time, and maybe even break the speed record for an Atlantic crossing. These were admirable goals but they ultimately led to tragedy. The Titanic also followed ISO 31000, Section 5.5.1.b., by "taking or increasing the risk in order to pursue an opportunity." They did so because they believed their risks were not extraordinary and could be controlled.   This is a common judgment error.

Mar 17, 2015

Infographic: How Evolved Is Your Quality Management System?


Is  your QMS primitive, civilized or somewhere in the middle? 
By: Lisa Weeks, Marketing Communications, MasterControl

Quality management systems (QMSs) have steadily evolved over time. The sophisticated systems of today are a far cry from the primitive paper-based systems of the past. They are faster, leaner, greener and just plain better. How did we get to where we are today? And is your company at the top or bottom of the QMS evolutionary chain? View the infographic, or keep reading to learn more about the evolution of the enterprise QMS.

Mar 12, 2015

The Journey to Supply Chain Excellence

A sound business network is key to a solid supply chain.
Top Resolutions for Building a Better B2B Supply Chain Operating Network for the Process Industries

By Ed Rausch
VP of Global Marketing, Elemica

Some goals haven’t changed. Businesses in 2015 still have the common pursuit of growing revenues, profits, and market space, and leading companies are relying on building collaborative relationships in their extended supply chains to meet these goals in a responsible and sustainable way. Building powerful and more intimate relationships, extending across a critical mass of trading partners, leads to continuous improvements in company performance, agility, and differentiation.

Mar 10, 2015

Data Integrity Starts With User Access

Colgin Consulting

Reprinted with permission from Colgin Consulting, Inc.

In my next few blog posts, we'll be covering user access and how it can impact data integrity. For starters, let's explore the Principle of Least Privilege. What is it?  What happens when it's violated? Finally we'll map out five actions you can take to protect your company.

You may need to pick up some new vocabulary.

Mar 5, 2015

3 Levels of SQF Certification

If you are interested in working in food safety, 
look into attending the SQF Certification program.
by Sam Lewis
Associate Editor, Food Online


SQF Certification is an assurance, assessment, and audit program that can increase your company’s marketability, domestically and globally.

The Safe Quality Food Institute (SQFI) operates under the motto of “One World. One Standard.” Its Safe Quality Food (SQF) Certification is the only one of its kind recognized by the Global Food Safety Initiative (GFSI) and is the only such program with a food-quality component added to its food-safety platform. SQFI’s goal is to utilize science-based, proven principles in order to consistently apply standards of food safety and quality on a global level. SQF Certification, recognized by all facets of the food-processing industry, is a measurement by which producers, suppliers, retailers, and consumers can be assured of safe, quality food products. SQF Certification virtually guarantees a higher degree of trust and acceptance in the global marketplace.

Mar 4, 2015

FDA Launches Drug Shortages Mobile App

FDA's new mobile app provides the public with 
rapid access to information on drugs in short supply.

by Christopher Kelly
FDA CDER Trade Press 

Today, the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages. The app identifies current drug shortages, resolved shortages and discontinuations of drug products.Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug products, which may be less effective or associated with higher risks than the drug in shortage.

“The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”

Mar 3, 2015

After Five Years, Compliance-First Approach is Still Obstacle to Improving Product Quality

The med device industry and regulators continue working 
to promote practices that result in high-quality 
devices by focusing on manufacturing quality.
by Dan Matlis
Founder and President, Axendia


SUMMARY
Five years ago we looked at the road blocks to improving product quality.  In the intervening years there has been little change by most Med-Tech Companies.  The matter of Product Quality vs. Compliance recently has been given a push toward the Quality side by efforts made by the FDA.  The four-part whitepaper reveals how aligning process improvement initiatives with technology platforms and an integrated approached to product quality can help Med-Tech organizations improve product quality, compliance and the bottom line.

Feb 26, 2015

Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple 
reasons to consider automating SOP management.

by David R. Butcher, Marketing Communications, MasterControl


To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.

Companies across all industries use standard operating procedures to minimize potential for miscommunication and to operate safely and more efficiently. Development and usage of SOPs are a key part of any successful quality system, as they provide employees with the information necessary to perform their jobs properly while facilitating consistency in the quality of processes and products.

Feb 25, 2015

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling 
your compliance efforts? Learn how 
to fix seven common document 
management mistakes.
by James Jardine

Marketing Communications, MasterControl


Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

Inefficient Manual Paper-Based Systems
Managing documents manually simply perpetuates a wasteful system that is prone to error. Plus, manual document management systems are often responsible for introducing quality problems that can result in product defects and regulatory penalties. And don’t fool yourself into thinking you’re any better off with that hybrid paper/electronic system you’ve Frankensteined together. It’s just as inefficient.