Sep 18, 2014

The Nine Elements of Lean Configuration

The Nine Elements of Lean Configuration
Nine elements comprise the Theory of Lean Documents
by José Ignacio Mora, Owner, 
Atzari Enterprises, L.L.C.

The allure of finally terminating your paper quality management system (QMS) feels very liberating. You can see the excitement in everyone's eyes during the new QMS software presentation.  Gone will be the days of paper engineering change notice---everything will be circulated and approved electronically and finally everyone will have time to do their jobs. They can hardly wait to tell their cubicle buddies about the new world they will soon live in.

Nine months later into the three-month project ...

Sep 16, 2014

Communicating Priorities to Your Employees

SVP, Marketing
MasterControl Inc.

Needless to say, if managers don’t understand corporate priorities, they can’t communicate them to employees. Entire departments may pursue the wrong priorities, causing stra­tegic corporate plans to become less effective. I’ve seen a lot of this. Likewise, if managers understand the priorities, but have not communicated them well to their departments, the results can be the same. And if employees are left to themselves to decide what the priorities are, not only are the efforts of your teams unlikely to match corporate goals, they probably won’t even match each other. You will likely have employees working in different directions, even within the same departments or even on the same projects.

Sep 11, 2014

INFOGRAPHIC: Closed-Loop Quality Management and the Cost of Inaction

by David R. Butcher, Marketing Communications, MasterControl Inc.

In today’s global manufacturing environment, continuing to rely on outdated, siloed quality management technology comes at a cost that many regulated companies simply cannot afford, new research indicates. That is why leading manufacturers are taking quality management further, leveraging EQMS to develop closed-loop quality processes that track quality throughout the value chain.

Sep 9, 2014

6 Best Practices for Enterprise Solutions Implementation

by Kevin Ash, Senior Vice President of Services, MasterControl

Investing in a powerful software solution can be extraordinarily valuable to your organization, yet the effort is wasted if it is not implemented effectively. To help ensure a smooth and successful implementation process, consider these six best practices.

All enterprise solutions implementations are unique, comprising their own complexities and challenges due to the technological and organizational change involved. However, there are certain requirements that are essential to the success of any implementation project. To improve the likelihood for success in an implementation project, consider the following best practices, based on MasterControl’s 90 percent implementation success rate among life sciences customers.

Sep 4, 2014

Choosing the Right Drug Name: How to Increase Your Chances for Approval

President, Med-ERRS

The pharmaceutical industry is all too familiar with how exceedingly challenging it can be to achieve a viable trademark that is accepted by the health authorities, especially if obtaining a global mark is the end goal. Over the past few years, health authorities in several countries have been developing their proprietary name guidances. In the last six months alone, both Health Canada and the FDA released guidances pertaining to proprietary name development – Health Canada’s proprietary name guidance was finalized and FDA released its first-ever initial draft guidance on the topic of name selection and development. Industry is now curious to learn how these guidances will affect their current trademark development and selection process and their trademark’s chance of approval.

Sep 2, 2014

FDA Issues New Q&A On Data Integrity

FDA Issues New Q&A On Data Integrity
FDA recently published a new set of seven questions 
and answers targeting GMP but applicable to 
anyone working in quality assurance.
by Jamie Colgin, Colgin Consulting, Inc.

Reprinted with permission from Colgin Consulting, Inc.

Recently FDA published a new set of seven questions and answers. Three questions cover data integrity and e-signatures. While the Q&A target GMP, there are lessons to be learned for all of us: 

Aug 28, 2014

What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan

What You Don't Know About the Drug Supply Chain Security Act (DSCSA) Implementation Plan
How do you know the prescription drugs 
you take are safe and not counterfeit?
by Peter Knauer, Senior QCC Consultant, MasterControl Inc. and 
Moj Eram, Regulatory Consultant

This article discusses the implementation aspects of the new Drug Supply Chain Security Act (DSCSA), which was signed into law (Title II of Public Law 113-54) by President Obama on November, 27, 2013. The Act intends to build a comprehensive, standard electronic and interoperable system to identify and trace prescription drugs in the US.1

Since the formation of the first FDA Counterfeit Drug Task Force in 20032, the agency has been engaged in efforts to improve and enhance the security of the drug supply chain at multi-level efforts that involves all stakeholders. The aim is to protect U.S.  patients from ineffective, counterfeit, low quality and unsafe drugs that enter to the market. Counterfeit, mislabeled, adulterated, or otherwise compromised prescription drugs pose serious public health safety concerns that are being addressed through the new Act. These drugs may be contaminated or contain faulty ingredients, inaccurate dosage, inactive ingredients or toxic ingredients. As a result of these drugs entering the market, patients risk their health by unknowingly using these faulty products.

Aug 26, 2014

Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers


In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

Aug 21, 2014

Regulatory Records Primer Part 1: Decoding the Requirements for Medical Device Manufacturers

Regulatory Records Primer Part 1:  Decoding the Requirements for Medical Device Manufacturers
Records, either paper or electronic,play a vital 
role in FDA’s ability to confirm that procedures 
have been appropriately implemented 
by Les Schnoll, Quality Docs, LLC


The Quality System Regulation (QSR) is premised on the theory that the development, implementation, and maintenance of procedures designed to carry out the requirements of the regulation will assure the safety and effectiveness of medical devices.  Therefore, it is easy to see the importance of the records required to document the implementation of those quality system procedures.
One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of medical device manufacturers) is the “Establish Test.”  The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.” 

Aug 19, 2014

Industry Expertise Sets MasterControl Apart from Competition

by James Jardine, Marketing Communications, MasterControl

Over the past two decades, MasterControl has flourished to become one of the world’s foremost providers of quality management software solutions and services. But innovative technology is not the only driver behind the QMS leader’s prosperity. In fact, it is the industry experience of MasterControl’s knowledgeable personnel that is the guiding force that propels the company’s continued growth worldwide.
Industry Expertise Sets MasterControl Apart from Competition
Discover how industry expertise motivates 
MasterControl to help customers succeed.

Approximately one-third of MasterControl’s staff comes from backgrounds in the business sectors that it serves, such as pharmaceutical, medical device, and general manufacturing industries. MasterControl has sought out the best and the brightest in these and other related fields to help develop and refine software and services that facilitate customer success. The know-how, familiarity, and empathy these experts have to offer helps MasterControl better steer the development of its products toward meeting customer needs because they have walked in the customers’ shoes. They understand the trials and complications of quality management, which makes them well qualified to provide the tools that can help quality professionals automate and simplify their tasks. Plus, they share the same goals and passion for their work as the regulatory and quality professionals that use MasterControl applications on a daily basis.

Aug 14, 2014

Medical Device Development: Thinking Globally, Acting Locally

Medical Device Development: Thinking Globally, Acting Locally
From a Medtech development standpoint, 
thinking globally  when developing the
“get-to-market” strategy for your device 
product needs to become the rule. 

by Timothy Blair, Director, Global Business Development, NAMSA and Seth J. Goldenberg, PhD, Senior Principal Scientist, NAMSA

Introduction: Medtech and the Healthcare Landscape
The global healthcare and healthcare service market will maintain steady growth due in large part to an aging population that is living longer and to improved healthcare services in emerging markets that include China, Brazil, India, Japan, Israel, and South Korea, among others. It is interesting to note that countertrends seem to be developing in the medical device space; for example, hospital utilization of medical devices has slowed significantly, reimbursements continue to tighten, and there was a first-time global decrease (5%) in US premarket approvals (PMAs) in 2012, a trend that continued into 2013. There were also fluctuations in investor healthcare spending across 2012, drops in mergers & acquisitions deal value and deal counts, and a device tax that is adding to the squeeze.

Aug 12, 2014

Certification: Is It Worth the Hassle?

Certification: Is It Worth the Hassle?
The road to certification can 
be irritating and upsetting.

by Lisa Weeks, 
Marketing Communications, MasterControl
In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process.