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. 

Sep 24, 2015

Secrets of Form Design: Forms Can Be Fantastic

A simple way to make implementation 
of your food safety processes straightforward 
is to make the reporting forms easier to use.

by Nye Joell Hardy

Food Safety Technical and Regulatory Writer

Okay, you’re ready.  You have your policy.  You have a great plan.  You have the SOPs.  Now all you need to do is implement it!  

But sometimes, turning all that paperwork into actual food safety or quality assurance activity will be the hardest part.

Sep 22, 2015

What Is a Food Safety Plan and What Is It Doing on My Table?

Would you like that burger with a side order of 
food safety plan? If the restaurant doesn't 
have one, you might want to reconsider your order!

by W. Lynn Hodges

HACCP Consulting Group, LLC

Whenever you go out to eat with your family, co-workers, or friends, you may be unaware that many of the restaurants (food service establishments) and retail food stores have some type of food safety plan in place.  Most of the chain restaurants have sophisticated food safety systems designed and implemented for their daily operations and as well as many of the larger, more established restaurants and retail food stores. The U.S. Food and Drug Administration encourages these retail food operations to implement food safety systems and use them throughout the everyday activities of the operations. 

Sep 17, 2015

Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

Can't find the right lid for the barrel?  You might find 
a different lid that almost fits and use duct tape. But if 
you do, chances are you'll be hacking your GMPs.
by Vivian Bringslimark
President & Owner
HPIS Consulting, Inc.

The subtitle tells it all.  Most employees don’t come to work with the intention to cause harm, fail or make mistakes intentionally.  Yet mistakes, errors, and failures happen.  According to Sidney Dekker, author of The Field Guide to Understanding Human Error, “mismatches between written guidance and operational practice always exist”.  I’s due to “the amount of increasingly tight constraints of procedures” (p.8).  There have been some occasions where following a procedure could have caused a deviation if it weren’t for an astute technician who questioned the “GMP” rule.   Talk about a GMP dilemma, “always follow the SOP” but don’t create a deviation either.  Alas, we have a classic example of a white hat hacker.

Sep 15, 2015

Multipurpose Tool vs. Best-of-Breed Platform: How to Tell the Difference

Beware of a multipurpose tool that claims to be a 
best-of-breed quality management platform. 
See if the software addresses six critical quality areas.
by Paul Sanderson
Lead, Solutions Consultants Group, MasterControl Inc.

When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?

Let’s apply this scenario to ERP systems. They are excellent for functions they are designed for like inventory management, procurement, and financials but many organizations use them for other things like document control and other quality-system functions that they aren’t designed for.

Sep 10, 2015

6 Steps to Simplify Software Validation

By following six steps, regulated companies are better
positioned to adopt and validate eQMS software with ease.

by Kevin Ballard, Director of Software Validation, MasterControl

Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software.

If your company is regulated by the Food and Drug Administration (FDA), you are required to validate your electronic systems to comply with 21 CFR Part 11 and 21 CFR 820, among other regulations. While the FDA requires validation, it does not specify how to validate. Rather, the agency wants evidence that you’ve documented how you intend to validate, and prove that you’ve done it the way you said you were going to. The goal is to ensure the software will work as expected for your use cases, and to make sure that any invalidated or altered records are easily identifiable.

Adhering to the FDA’s recommendation that companies pursue the “least burdensome approach” regarding validation activities, below are six steps to help reduce the time, pain and cost of validating an eQMS system.

Sep 9, 2015

Inspecting Clinical Trials - MHRA on the Trial Master File

Does your trial master file (TMF) look
 like this?  It doesn't have to if you 
move to an electronic system.

by Gail Francis
Expert Inspector,

The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights some of the issues which have been experienced by sponsors and inspectors attempting to manage and review the large amounts of documentation that exist in support of a trial.

Sep 8, 2015

Building Forms for Regulated Environments: Top 10 Best Practices

Editor, MasterControl Insider

Whether you’re applying for a job or a loan, or registering for a conference or membership in some organization, there’s one thing you must do—fill out a form. We can’t live without forms. In regulated environments, they are even more crucial because they can affect regulatory compliance.

Life science organizations under the jurisdiction of the U.S. Food and Drug Administration (FDA) use an array of forms such as corrective action and preventive action, complaint, and change control (engineering change request, design change request, etc.). These forms are necessary to gather, capture, and process data, which usually need to be reported and analyzed as part of compliance. 

Sep 3, 2015

The CAPA Detective

In the GMP world, the CAPA investigator 
is the detective, identifying how and 
why manufacturing defects occur.
by Laurie Meehan
Social Media Manager
Polaris Compliance Consultants

Every industry has its detectives. Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs. Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

In the GMP world, it’s the CAPA investigator who serves as detective, identifying how and why manufacturing defects occur.  The root cause is seldom obvious or sensational, but usually a confluence of seemingly innocuous deviations that can compromise an otherwise high-quality manufacturing process.  That’s not terribly flashy, so you probably won’t find “The CAPA Detective” in among the other crime dramas making their debut in this year’s prime time lineup.

Or maybe you will. 

Sep 1, 2015

The Patient is Missing

Clinical volunteers can choose to walk away 
any time they want and to clinical 
trials they may be irreplaceable.

by Amy Musolino
Program Director, New Service Development
Fisher Clinical Services

Recently, I had the opportunity to attend a presentation by Patricia Larrabee, CEO and founder of Rochester Clinical Research. While there, I couldn’t help reflecting on the truly significant contribution that patients play in the success of clinical research. Furthermore, what a burden we often inadvertently place on them as well as our investigator sites.
Pat was the keynote speaker at a recent Insights event and presented the topic “What Does it Really Mean to be Patient Centric?” During her presentation, she discussed the new buzz word in the industry right now, “patient centricity.”