May 30, 2017

When GCP & GMP Meet

Developments on the manufacturing side of the
house can affect the clinicians conducting clinical
studies and must be communicated in a timely manner.

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants

Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.

Trialed Drug vs. Marketed Drug

Once researchers are satisfied that animal studies show that an Active Pharmaceutical Ingredient (API) is effective and nontoxic at initial doses, there’s an urgency to get it into the clinic and begin human studies as soon as possible. Though the ultimate product may be marketed in one form, a different form may take less time to manufacture, and so would be the form given to human volunteers in earlier clinical trials.

May 25, 2017

How an Electronic Quality Management System Helps With Cybersecurity

by David Jensen

MasterControl, Staff Writer

For medical device manufacturers, technology is a double-edged sword. The technologies that elevate the quality of life for patients can be used by cyber actors to undermine both the manufacturing organization and the products themselves. This means cybersecurity is as much a quality issue as it is a security issue.

Preventing all security threats and attacks is simply not possible. Therefore, the focus needs to shift from prevention to rapid detection, risk analysis and recovery. To further complicate things, cybersecurity is not just about technology. There is a human component involving users’ online activities that companies need to address with cybersecurity polices. This is where an electronic quality management system (EQMS) can be a valuable asset for assisting with your cybersecurity efforts.

May 23, 2017

The 15 Strangest Phobias and Why They Include the Fear of Paper

Phobias are nearly impossible to understand
with the logical mind. What are you afraid of?

by Marci Crane

MasterControl, Staff Writer

It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

On the other hand, it is easy to identify 15 phobias that exist outside the realm of the more common phobias, or those most people have heard about, such as arachnophobia, the fear of spiders; acrophobia, the fear of heights; or even coulrophobia, the fear of clowns, to name just a few.

May 18, 2017

Keeping Up with the Top Pharma Industry Trends of 2017

The pharmaceutical industry has realized steady worldwide revenue growth over the past 15 years[i], but there is an array of impending technological, regulatory, socioeconomic, and political changes on the horizon that may significantly impact pharma companies’ bottom lines. In a new white paper titled “Five Pharma Trends that Will Have the Biggest Impact in 2017,” Patricia Santos-Serrao, RAC, MasterControl’s director of clinical and regulatory solutions for pharmaceutical, blood, and biologics industries, outlined the most critical issues affecting the pharmaceutical industry in 2017. The following are several of the exigencies she points to as this year’s major pharma forces.

May 16, 2017

The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

The food enforcement world is changing, and companies need
 to understand four key developments and how to get ahead of them.

by Maile Gradison Hermida

and Brian D. Eyink

Hogan Lovells US LLP

With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare for this “new normal” in FDA enforcement.

May 12, 2017

What is a Document Control System?

How to get control of your 

document control system

by David Jensen

MasterControl Staff Writer

Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

SOPs, calibration instructions, procedures, packaging and storage instructions, test plans and validation checklists are just a few of the documents you create and use during a product’s development lifecycle. When the product is on the market, you add in manufacturing history records, change orders, complaints and corrective action reports.

May 9, 2017

What is a Document Management System and 8 Reasons Your Company Probably Needs One

Piles of files or an electronic document 
management solution:  which 
would you choose?

by Marci Crane

Staff Writer

A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

What Do Document Management Systems Do?

Document management systems:
  •       Allow for the input of scanned hard-copy paper files into a secured storage
  •       Store documents in one or more secure locations (levels of security vary based on the system itself and on client’s industry and specific needs)
  •       Automatically route documentation to approved users (routes are based on business processes) 
  •       May track all versions of each document in the system (often requires version control capabilities as well as time-stamping technology)
  •       Provide search capabilities (the level of sophistication with the internal search engine of a document management system varies based on the system’s intended design)
  •       May provide a form of validation for regulated industries (for example, for the life science industries, document management systems can assist in demonstrating compliance with FDA requirements and additional international standards.)

May 4, 2017

Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

by Cindy Fazzi

MasterControl Staff Writer

Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

In the field of quality management, it seems the forecast remains unheeded. A report based on informal polls by MasterControl reveals that the majority (59 percent) still don’t use an electronic system to manage audit and quality processes. The polls also showed that quality issues resulting in stoppages were costly, with 27 percent saying their companies spend between $100,000 and $1 million due to quality-related interruptions.

“I was surprised how many companies don’t have an automated system,” said Curt Porritt, MasterControl senior vice president of marketing. “I was also surprised how much time and money can be lost due to quality issues.”

May 2, 2017

10 Criteria to Aid in the Selection of Investigative Sites

Site selection is pivotal to the successful 
execution of trials. Choose high performing 
sites that are ideally suited to running 
the study under investigation.

by Craig Morgan

Head of Marketing 


Investigative sites are the heart and soul of clinical trials, essential to ensuring the efficacy and safety of pharmaceutical compounds in humans. Site selection is pivotal to the successful execution of trials, which are not only long and bureaucratic, but are also experiencing diminishing returns. Studies estimate that it costs upwards of $2B dollars to bring a new drug to market, with daily revenue losses in ranging from $1M to $8M due to delayed market entry.

Key to reining in budget overruns and delays, often fueling the growing rescue studies industry, is the selection of high performing sites that are ideally suited to running the study under investigation. The selection process is, however, often manual, cumbersome and error prone.

The numbers tell a sobering tale.