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.

Aug 7, 2014

Version 11 of MasterControl Features More New Enhancements than Any Previous Release

by James Jardine, Marketing Communications, MasterControl
The recently released version 11 of MasterControl software dramatically accelerates customers’ ability to deliver life-changing products to those who need them most. Constructed largely in response to customer input, MasterControl v11 includes 560 new enhancements and represents more than 65,000 man hours of software engineering.  

A new website tells the complete story of MasterControl v11. 
Version 11 of MasterControl Features More New Enhancements than Any Previous Release
“How often do you hear companies say, ‘We heard your suggestions and complaints, so we improved the product’?” said Brian Curran, MasterControl Senior Vice President of Strategy and Product Management. “MasterControl Version 11 is better, bigger, and faster because we listened to our customers.”
With a focus on improving the overall customer experience across all touch points, the new v11 release is intended to make it easier for the basic user to take advantage of all of the software system’s functionality. In addition to improving ease of use, MasterControl v11 drastically enhances scalability, security, and accessibility.

Aug 5, 2014

5 Ways to Cut Medical Device Development Time with Embedded Design Teams

5 Ways to Cut Medical Device Development Time with Embedded Design Teams
 While designers are embedded in a clinical environment, 
embedding a clinician on-staff with a design team 
also improves the availability of feedback.
by Chris HammondDirector of Insight & Innovation, Kaleidoscope and Sean J. Barnett, MD, MS, FACS, FAAPChief Medical Officer,

Overcoming regulatory pitfalls of medical device development with early clinical involvement.
For medical product development, the rigors of input gathering and iterative concept testing may slow down innovation process and subsequently increase costs. Building on user-centered design principles, creating an Embedded Design Team with clinicians and design professionals in a co-creation atmosphere provides a revolutionary way to drive speed to market.