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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 

goBalto


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.

Apr 27, 2017

"We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work



Lean process improvement techniques 
can be applied to knowledge work and
knowledge workers.

by Drew Locher

 

President

 

Change Management Associates


If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

Knowledge work and knowledge workers are different. But that doesn't mean process improvement concepts don’t apply. It does mean we have to adapt the concepts and approaches by practicing these proven techniques.

Apr 24, 2017

20 Years Later, 21 CFR Part 11 is More Relevant than Ever


by Cindy Fazzi


Staff Writer, MasterControl


If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

First off, what’s new with Part 11? Every now and then, there are rumors about updates. The on-again, off-again speculation stems from the FDA’s “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application.”

The 2003 guidance says: “While the re-examination of Part 11 is underway, we intend to exercise enforcement discretion with respect to certain Part 11 requirements” (1). And yet, neither re-examination nor update is apparent.

Apr 20, 2017

What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level


Does preparing for your next
audit give you a headache? PDCA
may help reduce your audit stress.

by Bryan Armentrout


CEO, The Food Leadership Group


Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

Does this Scenario Sound Familiar?

A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the quality assurance (QA) manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”


Apr 18, 2017

Human Factors: Why it is Critical in Designing Medical Devices

Human factors helps design out 
the opportunity for human error

by David Jensen

MasterControl Staff Writer


“Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 
---Douglas Adams.

This quote hints at the importance of human factors in technology in medical device design and development. Rollin Fairbanks, director, National Center for Human Factors in Healthcare, talked about human factors and its critical role in medical device design at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14, 2016.

Many issues or mishaps involving medical devices can be attributed to human error. However, instead of focusing on discipline, mindfulness and training of end users, Rollin stressed that human error cannot be eliminated, but it can be significantly reduced with the right approach to product design.