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Oct 30, 2014

How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market


Successful product development requires the orchestration 
of multiple complex systems and processes, sometimes 
requiring worldwide coordination.
by Lisa Weeks, Communications Specialist, MasterControl


Having a great product does not guarantee success. The road from concept initiation to commercial release is a long and arduous one. Success depends upon not only understanding the new product development process, but also the FDA submission process, and the complex interplay between the two. Many companies underestimate the value of a carefully thought-out submission strategy. They focus solely on product development and treat the approval process as an afterthought. Others are so eager to get their product to market, they rush the design and testing processes and end up with a product that’s dogged by costly delays or, worse, unmarketable.

Successful product development requires the orchestration of multiple complex systems and processes, including design control, compliance management, and risk analysis/assessment and design and process validation. Is your company’s new product development program equipped to handle all of these elements in an environment that’s constantly changing due to new technologies, regulations and competitive activity? Few are.

Oct 28, 2014

What Is Driving More Organizations to Plan an EQMS Adoption?

What Is Driving More Organizations to Plan an EQMS Adoption?
Planned EQMS adoption rates are accelerating 
as the tech matures. What are key drivers
 behind this growth?

by David R. Butcher, Marketing Communications, MasterControl


In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?


Oct 23, 2014

From Good to Great – the One Skill Great CRAs Possess

From Good to Great – the One Skill Great CRAs Possess
To be a great CRA, one skill is needed:  active listening.
by Holly Deiaco-Smith, MS

What skill differentiates a good clinical research associate (CRA) from a great CRA?

a.  Knowledge of clinical processes and the regulations that govern them?
b.  Ability to be flexible with travel and work schedules?
c.  Ability to spot errors that could gravely impact data and ultimately patient safety?
d.  A relentless zeal for ensuring assigned sites are “buttoned up?”

The answer- none of the above. 

Don’t get me wrong, these skills are important and they are point of entry for a good CRA. These skills are expected as a minimum set of skills to be hired for the job of CRA but they are not the skills that differentiate a great CRA. 

Oct 21, 2014

Evaluating the Effectiveness of a Corporate Compliance Program: A Holistic Approach



Dahl Compliance Consulting

Now more than ever, pharmaceutical companies must not only have an effective corporate compliance program in place, but senior management and boards of directors at these companies must ensure that they evaluate the effectiveness of those programs.  The best reason to evaluate the effectiveness of your compliance program is so that you know whether or not the program is managing the particular risks facing your company.  If you are responsible for protecting your company from risk, shouldn’t you want to know that your compliance program is working?

Oct 16, 2014

Why Food Makers Are Investing In Food-Safety Software

Why Food Makers Are Investing In Food-Safety Software
by Sam Lewis
Associate Editor, Food Online


Throughout 2014, food makers have put forth significant efforts in pursuit of food-safety and quality-management software solutions. But why is there so much interest and effort in these systems now?

The Obstacle Of Paperwork

To put it bluntly, handling paperwork is a burden that creates more problems than it solves. A misplaced invoice, a forgotten signature, an accidentally destroyed document… all of these scenarios can wreak havoc on a quality-manager's workload. Not to mention the bottleneck it creates on workflow. Developments in supply-chain management, fraud prevention, and food safety are only extending and complicating the labors of safety officers. Fortunately, software solutions and automated processes are able to take on these added tasks and ease the minds of safety and quality-assurance workers.

Oct 14, 2014

FDA vs. EU Inspections: Similarities & Differences

IPRF, LLC – RA/QA Consulting & International Product Registration

EU-FDA Joint Initiative

The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

These joint GCP inspections come under an arrangement between the European Commission, the European Medicines Agency (EMA), and the FDA. The initiative allows them to streamline the sharing of information on inspection and observations and facilitates the conduct of collaborative inspections. The goal is for European Union (EU) inspectors and FDA inspectors to have the same information about a facility. 

Oct 7, 2014

INFOGRAPHIC: U.S. Manufacturing Facts and Figures

by David R. Butcher, Marketing Communications, MasterControl

Last Friday marked the third annual Manufacturing Day (MFG DAY), a growing grassroots movement of manufacturers dedicated to bringing attention to modern North American manufacturing and empowering the professionals who compose it. Here we highlight some of the contributions of U.S. manufacturers to the nation’s economy.

Since 2012, manufacturers all across the United States, U.S. territories and Canada have opened their doors to the public on the first Friday of October, and often throughout the month. Organized by the Fabricators & Manufacturers Association (FMA), the National Association of Manufacturers (NAM) and the National Institute of Standards & Technology’s (NIST) Manufacturing Extension Partnership (MEP), MFG DAY is designed to highlight new technologies and innovations, address common misperceptions about the sector and inspire the next generation of manufacturing professionals.

Oct 2, 2014

The 3 Biggest Project Management Problems in the Regulated Environment


Lead, Solutions Consultants Group, MasterControl Inc.

Effective project management helps your company save time and money by keeping projects on time and on budget. It optimizes your resources by assigning the right people with the right skills for every project. In a regulated environment, you need all of these, plus one more crucial consideration: compliance.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Health, Labour and Welfare (MHLW) in Japan expect companies under their jurisdictions to have a formal project management plan that addresses relevant requirements, design control, and change control, among other things.