Oct 20, 2016

4 Quality Management Tips We Can Get From Time Travel Movies

by David Jensen

Marketing Communications


Ever wish you could have a do-over? Wouldn’t it be nice to be able to go back in time to change or undo some event? Or what about going to a future time? Nothing illegal, maybe just to avoid the lines and hassle of getting a ticket to the next episode of Star Wars.

If you’re in quality management and an auditor hands you a list of inspection observations or a warning letter, the notion of going back in time might seem appealing.

Actually, Jules Verne and H.G. Wells aside, when it comes to quality management, the whole space-time continuum thing might not be so far-fetched. With the changing regulatory landscape and manufacturing processes, manufacturers are exploring more effective ways of managing quality. Companies hoping to sustain productivity and momentum while staying compliant are applying more of a closed-loop approach to quality, which, in essence, is a form of time travel.

Oct 19, 2016

10 Tips for Enabling Better CRO-Sponsor Collaborations

The sponsor-CRO relationship is not 
always a win-win but parties should 
strive for a positive outcome.

by Craig Morgan

Head of Marketing

goBalto, Inc.

By 2020 72% of clinical trials are anticipated to be outsourced, up from just 23% in 2012. Sponsors are seeking cost reductions, access to specialized knowledge, and increased speed and agility. Meanwhile, CROs focus is on business goals related to economic outcomes for their owners, investors and shareholders. Each group is expecting deliverables and timelines to be met or exceeded for potentially different business reasons, leading to a traditional client/vendor-type relationship. Though alliances and partnerships are increasing, there continues to be a client/vendor mentality at the operational and management levels, which perpetuates a lack of trust and empowerment.

Oct 18, 2016

Renowned Physician Patch Adams Urges Techies to Help Build an Ethical World

by Cindy Fazzi


MasterControl Insider

Patch Adams, the physician famously played on the silver screen by Robin Williams, urged IT professionals to help build an ethical and nonviolent world during his keynote speech at the 2016 Masters Summit in Salt Lake City.

“The IT world offers the strongest possibility for a revolution. You’ve made the world your living room. Let’s do something,” said Adams, a family doctor, humanitarian, activist, author, and clown. He spoke to a standing-room only crowd about what he called the “most radical medical project in the world.” 

More than 500 people attended the ninth Masters Summit, MasterControl’s premier annual educational conference for its customers. This year, it was held in Little America Hotel in Salt Lake City, from Oct. 11-13, 2016.

Oct 13, 2016

Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

Planning for disaster will 
keep your supply chain 
from sliding into 
The Dark Side.

by Ed Rusch

Vice President, Corporate Marketing


Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

Sometimes there are advance warnings; sometimes not. Some events are highly unlikely ever to occur; others are probably just a matter of time. The severity of impact might affect only a small area, or an entire business sector, or it could be (or become) catastrophic.

Oct 6, 2016

How Well Do You Know Your FDA History?

Efforts to promote safe, effective 
products go back 300 years! 

by Lisa Weeks

Marketing Communications


Editor’s note: This is part one of a two-part series.

Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start—new teachers, new clothes, new school supplies. I'm dating myself here, but was there anything better than a brand spanking new Trapper Keeper®?

For those of you who don’t know, the Trapper Keeper was THE 80s school supply must-have: an ultra-cool 3-ring binder with an outer shell (the “keeper”) that held glossy primary-colored folders (the “trappers”) and featured a fold-over Velcro closure to keep it shut.

Oct 4, 2016

Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

21 CFR Part 11 is one of the FDA 
regulations and initiatives that 
helped modernize compliance 
for life science companies.

by Cindy Fazzi

Editor, MasterControl Insider

Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

Matt Lowe, a mechanical engineer and medical device industry veteran, describes the struggles of life science companies in the old days of manual processes in his newly released e-book, “Convergence of Compliance and Technology.”

In his first job as a product development engineer at a medical device firm, the change control process for getting a new drawing through the system resembled an obstacle course that required a lot of time, effort, and patience. The simple act of document submission was anything but simple.

Sep 29, 2016

How to Use Postmarket Surveillance Data to Gain a Competitive Edge

There's a treasure trove of PMS 
data you're probably not using.

By Lisa Weeks, Marketing Communications, MasterControl  

Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

Sep 27, 2016

Tweet This — If You Want to be Slapped with an FDA Warning Letter

These do's and don'ts will help you
 engage with customers compliantly.

 by Lisa Weeks

 Marketing Communications,      MasterControl

Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers. 

Sep 23, 2016

Preparing for the Impending Medical Device Regulation

The Medical Device Directive (MDD) 
is being recast as the Medical 
Device Regulation.  It's time to 
learn some new rules.

by Linda Chatwin, Esq, RACUL, LLC Senior Customer Solutions Consultant

It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.

Since the MDR is now a regulation as opposed to a directive, the member states in the EU are bound to abide to it – giving it strength equivalent to the FDA’s CDRH regulations in the US. The EU is the world’s second-largest medical device economic area/region, and the regulation, felt to be long overdue, will regulate devices not only manufactured and marketed within the EU, but also devices that will be imported into the EU.  The regulation includes rules for determining device classification, requirements for quality systems, obtaining pre-market authorization, and monitoring device performance in the field, including reporting of adverse events.

Sep 20, 2016

Identifying and Preventing Common Data Integrity Issues

Data integrity is important to the 
quality control laboratory because poor
practices can allow for substandard 
product to reach patients.

by Joanna Gallant

Owner/President, JGTA, LLC

Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today.  Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality.  The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.
Data integrity is of particular interest in relation to the quality control laboratory and the handling of OOS results, because poor practices can allow for substandard product to be put into the hands of patients.  But the same holds true for any other area that generates or controls data – including IT, R&D, manufacturing – any data integrity failures from these areas can also impact patient safety, product and process quality effects.

Sep 15, 2016

Is Compliance an Obstacle to Quality?

The FDA is shifting from a primary focus on 
regulatory compliance to driving the industry 
beyond compliance by focusing on product quality.

by Daniel Matlis

Founder and President, Axendia

Editor’s Note:  Recent news about FDA’s Quality Metrics initiative triggered an “I told you so” moment: Is Compliance an Obstacle to Quality? Axendia wrote this article over two years ago in Life-Science Panorama (http://axendia.com/blog/2014/04/14/is-compliance-an-obstacle-to-quality/ ).  It’s as true today as it was then.

Can you distribute poor quality products while complying with regulatory requirements?  Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

Regulatory compliance and quality are NOT the same.  In fact, the industry’s hyper-focus on compliance is often an obstacle to quality.

Sep 13, 2016

"Hacking" Quality

Can quality be "hacked?"  Do Deming's 
tenets of quality still stand or  
is it time modify them?

by Peter Holtmann

President & CEO

Exemplar Global Inc.

Continuing my theme of the future of quality, the ability to see the future could come through some interesting lenses—hacking, for instance.


A clever solution to a tricky problem.

To hack is to modify or change something in an extraordinary way. (Urban Dictionary)

While a more traditional definition of hack may be along the lines of roughly cutting away at something, the younger generation’s perspective of hack, as defined above, describes how the term serves their lifestyle.