Nov 25, 2014

Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop?

Mind The Gap: Are Training Gaps Preventing You From Closing The Quality Loop?
Learn five tips for addressing common training gaps.
by Stephanie Jones, Senior Professional Services Consultant, MasterControl
If you follow GxP Lifeline regularly, you’ll notice that we’ve been talking a lot about the concept of closed-loop quality recently, and here’s why. In the face of an increasingly competitive business environment, manufacturers are discovering that traditional approaches to quality management are no longer working (and haven’t been for quite a while). Treating compliance as a series of data or process silos that vary with department or product lifecycle stage simply won’t cut it anymore. A closed-loop approach is what’s needed today because it provides a more holistic view of product and process quality throughout the value chain as well as a considerable competitive advantage.

Nov 20, 2014

It's Not Just You: FDA Regulatory Requirements Really Are Increasing

The work of regulatory professionals working in the United States is notoriously tough. There are thousands of regulations to know, scientific knowledge to understand, colleagues to convince and regulators to placate. And now new data supports a commonly held belief: Your job really is getting more difficult every year.

According to data made available by George Mason University's Mercatus Center and analyzed by Regulatory Focus, the number of regulatory requirements imposed by the US Food and Drug Administration (FDA) increased by 15% between the years 2000 and 2012.

Nov 18, 2014

Recognition is a Good Thing

This year, MasterControl was recognized for 
performance excellence by Software Magazine.

by Robyn Barnes
PR Specialist, MasterControl

It’s always nice to know when you are doing well, especially when you’re recognized within your own industry.

This year, MasterControl was recognized for performance excellence by several industry organizations. 

The first accolade came when Software Magazine included MasterControl for the third time in its Software 500 ranking of the world’s largest software and service providers.  MasterControl ranks 369.

"We're very pleased to once again be included in this list of providers," says MasterControl CEO Jon Beckstrand. "This inclusion is an indication of the quality of our product, our customers and our employees."

Nov 13, 2014

MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs

MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs
FDA’s Office of Regulatory Affairs (ORA) is 
expanding its use of MasterControl's software.
by Cindy Fazzi
Editor, MasterControl Insider

The U.S. Food and Drug Administration (FDA) has been protecting American consumers for over 100 years. In the face of increasing global interdependence, the FDA’s responsibility has expanded by necessity; it works with its counterparts throughout the world to help ensure product safety and quality.

The FDA’s emphasis on quality standards is reflected in its vision to dedicate itself to “world-class excellence as a science-based regulatory agency with a public health mission.” The same vision drives the FDA’s Office of Regulatory Affairs (ORA), the lead entity for all of the FDA’s field activities. ORA states plainly its commitment to quality and continual improvement (1). It emphasizes quality within its ranks and applies the same rigorous quality standards it expects from the industry.

Nov 12, 2014

American Laboratories Begins Phase II of MasterControl

American Laboratories Begins Phase II of MasterControl
ALI has been using MasterControl Training and 
MasterControl Documents over the past two years.
American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

 MasterControl is used by hundreds of companies worldwide to facilitate compliance management by automating and managing document and change control, training management, audits, corrective/preventative actions (CAPA), customer complaints, nonconformance disposition, deviation handling and other GxP processes critical to regulatory compliance.  

Nov 11, 2014

MHRA Opens One Stop Shop for Regenerative Medicine Information

MHRA Opens One Stop Shop for Regenerative Medicine Information
MHRA is offering one-stop shop regulatory 
advice for life science professionals
 working on regenerative medicines
by Robyn Barnes
PR Specialist, MasterControl

A new ‘one stop shop’ that will provide regulatory advice for those working in the life sciences industry on regenerative medicines has been launched, according to the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA).  MHRA is an executive agency of the Department of Health in the United Kingdom responsible for ensuring that medicines and medical devices work and are acceptably safe.

The service will, for the first time, provide a single point of access to regulatory advice from the four regulatory bodies that work in the sector.

Nov 6, 2014

MasterControl Says “Go Live” to Localized Websites

MasterControl Says “Go Live” to Localized Websites
MasterControl’s international efforts included the 
recent launch of three new localized websites.
by Jason Clegg
Director of Marketing, MasterControl

At its core, website translation is a process that allows everyone across the globe to access the same opportunities and/or products in their own languages. This is especially important to companies like MasterControl that are expanding in to international markets.

 “MasterControl has worked continuously over the last few years to build its international presence,” says CEO Jonathan Beckstrand. “We want everyone to be able to manage safer and more effective manufacturing processes no matter what kind of life-saving product(s) they are invested in creating.”

Nov 4, 2014

Surviving ISO 9001:2015

VP Operations, Oxebridge Quality Resources

The next revision of ISO 9001 is due in 2015, and the standard is being anticipated with more controversy than any previous edition. The document, now in its Draft International Standard (DIS) stage, is nearly a done deal, with very few changes likely before it progresses to its final release.

Despite some online bluster, the changes are not as significant as some would have you believe. Using simple word count comparison against the current 2008 version, we find that 74% of the changed wording was merely rephrasing of existing requirements, without any new requirements; of the remainder, 20% are new requirements mandated by ISO bureaucrats, and 6% is new wording introduced by TC 176. That is good news for those who don’t want to spend a lot of money “updating,” but bad news for anyone expecting ISO 9001 to evolve into a more modern, 21st century standard.

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?