Apr 16, 2015

Your Biggest End-User Training Problem—Solved!

E-learning makes it easier to 
train your global workforce.
by Donna Cline, Senior Instructional Design Specialist, MasterControl 

According to Forbes magazine, the global e-learning market is projected to reach $107 billion in 2015.(1) What’s driving the demand? Employees work in offices (and at home) all over the globe. Traditional face-to-face instructor-led training (ILT) or classroom learning is often too impractical for today’s geographically dispersed workforce. E-learning, also known as online or Web-based learning, solves what is arguably the biggest challenge training coordinators face: How do I reach my scattered workforce?

Apr 14, 2015

5 Practices for Managing Change When ISO 9001:2015 Arrives

by Terrance Holbrook, Senior Product Manager, MasterControl

Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.

When the revised regulatory requirements go into effect, will your organization be prepared to implement the necessary changes smoothly? Will it be able to look at the requirements in a proactive way and turn the challenges of change into opportunities for success?

Apr 9, 2015

Keep Calm & Go Live: 8 Tips for a Seamless Software Implementation

Learn how to keep your cool 
under go-live pressure.
by Stephanie Jones,
Senior Professional Services Consultant, MasterControl  

Does this scenario sound familiar? You have the perfect software implementation team assembled. Together you’ve configured, tested, reconfigured and reconfigured some more. You’ve written and/or updated your standard operating procedures (SOPs), created your user training materials, validated your new system and trained your user community. Now it’s time to go live, and your knees are knocking. What do you do? 

Apr 7, 2015

Regulatory Tools Go UFO: Useful, Free & Online

Internal Project Manager, Polaris Compliance Consultants, Inc.

Despite your best efforts, if you’re active in social media, you’ve been drawn into pointless conversations.  Indeed, that’s why many people stay away.  But if you can tolerate a little noise, I’ve found that the fruitful far outweighs the fruitless.  Case in point:

LinkedIn Member 1: “This looks like a great resource. I just hope they are planning on adding more countries.”
[I bet you wanna know what he’s talking about. Stay tuned.]

LinkedIn Member 2: “Don't you find it encouraging there are more and more online tools available to us?”
[Who is this sickening optimist?]

LinkedIn Member 1: “I do find it encouraging. What's the best way to keep up with all these new tools? Is there a web site keeping track of them?”

Apr 2, 2015

Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

MasterControl's Market Segment Manager
Global Pharmaceutical, Blood & Biologics

When describing the role of Regulatory Operations I have found that one of the best analogies of their role and responsibilities is to be the “air traffic control tower for interactions between a life sciences organization and a regulatory authority.” By no means is that their only role but it is an essential role that involves constant communication with various parties both internally as well as externally. Regulatory Operations personnel coordinate resources and documentation essential for filing of global applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations.

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

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.