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May 29, 2014

How Can You Measure the Return on Your QMS Investment?

by James Jardine, Marketing Communications, MasterControl Inc.

Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

Survey responders noted that prior to implementing MasterControl, the average knowledge worker was spending 20 percent of his or her time searching for information that already existed somewhere within the company. In an organization that employs 50 knowledge workers, for instance, that amounts to 17,680 hours wasted each year just because personnel couldn't find the information, documents, or data they required when it was needed. That’s the equivalent of devoting 10 full-time employees every year to searching for information that already exists!

May 27, 2014

How to Cut Your Document-Approval Cycle Time Using Escalation

Do your document approvers go
through  piles of files for hours,
signing off until they drop?
by Marty Jackson
Professional Services Consultant, MasterControl Inc.

From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?

Here’s an example of a scenario in a company with a paper-based process. Once a week, approvers are “sequestered” in a conference room, where they face a big pile of documents. They go over the documents, frantically signing off for several hours or until they “drop.” 

May 22, 2014

Ruined by Best Efforts

Ruined by Best Efforts

By Craig Gygi, Executive Vice President, MasterControl Inc.


When W. Edwards Deming famously said, “We are being ruined by ‘best efforts,’” he was conveying the idea that simply striving to improve—even with laudable effort—can actually have the opposite outcome. How can this be? How could good intentions and diligent work ever possibly sabotage us? Well, they do all the time.

May 20, 2014

The Top 6 Pains in DHF Management



Are you wondering why you are having  difficulty managing your device history file?
Are you wondering why you are having
difficulty managing your design history file?

By Matthew M. Lowe
Executive Vice President, MasterControl Inc.

In my experience working in medical device product development and product management, maintaining the design history file (DHF) posed daunting challenges because it was a process that continued throughout the lifecycle of a product. Even years after a medical device is launched, it’s not uncommon for the technical lead to revisit the DHF because the product is undergoing an iteration or it’s being launched in another part of the world.

If your DHF is paper-based or hybrid (part electronic and part paper-based), the challenges grow exponentially. Having worked as a development engineer in medical device firms and now as an executive in a software solutions provider that helps medical device and other regulated companies, I have seen the view from both sides of the fence.
Here are some of the biggest hurdles I’ve experienced and seen pertaining to DHF management in a paper or hybrid environment.

May 15, 2014

Building a Vendor Qualification Program for FDA Regulated Industries

Building a Vendor Qualification Program for FDA Regulated Industries
Always qualify your vendors, even if they are 
recommended by someone you trust.
By Jonathan M. Lewis, Advanced Biomedical Consulting

Introduction
While being conscious of the products and services purchased is good practice for consumers and most businesses, it is a regulatory requirement for FDA regulated industries. For these organizations, the decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be well informed (and documented). The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company. This article presents a practical and compliant methodology for firms in FDA regulated industries to qualify vendors and hence make well informed purchasing related decisions.

May 13, 2014

Understanding European Declarations of Conformity or Incorporation

Understanding European Declarations of Conformity or Incorporation
By Robyn Barnes, Marketing Communications, MasterControl Inc.


In the wonderful world of medical device regulation, a manufacturer may find it easy to become confused with FDA rules.  When your product moves to the international market, there are new rules that must be followed to get your product to market. 

If you want to sell internationally, you’ll have to understand the difference between certification and marking.  What challenges do they present and what are they used for? Doug Nix does a great job of explaining the concepts in “Understanding European Declarations of Conformity or Incorporation.”

May 8, 2014

Strategies for Addressing the Top 3 Quality Pains in a Regulated Environment



By Paul Sanderson
Lead, Solutions Consultants Group, MasterControl Inc.

In the past 10 years that I’ve been working with highly regulated companies, I’ve seen many organizations find out the hard way that quality does not occur by accident. Quality requires good planning, design, and execution.


The “quality pains” most companies experience stem directly from having an ineffective and inefficient quality management system (QMS), usually paper-based or hybrid. I will discuss the most common pains I’ve seen and offer some recommendations. If your company is developing a QMS or revamping your existing QMS, you may be familiar with some of these pains.

May 6, 2014

Six Easy Criteria for Targeting a Good Process

Six Easy Criteria for Targeting a Good Process

Reprinted with permission of Jason Piatt, President, Praestar-Consulting and Praestar-Consulting.com

Whether we’re practicing Lean or Six Sigma, what we’re really targeting is process improvement. The process could be technical, commercial, or a support-process to the standard order-to-delivery process within the context of our manufacturing environment. All too often, manufacturing executives mistake a sequence of activities to be a process. That’s simply not the case. So, what makes a good process? 

May 1, 2014

How Do I Follow The Trail?


How Do I Follow The Trail?
Follow the audit trail one step at a time.
By Jamie Colgin, President, Colgin Consulting, Inc.

One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: "Imagine I'm a sample arriving at your loading dock. What happens to me?" We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage.

While you can start at any point in the process, if you're new to this, I recommend starting at the beginning. Figure out what should be happening and then find out what actually happens.