Dec 18, 2014

Basics: Documenting a Real QMS

Basics: Documenting a Real QMS

Plan/Do/Check/Act (PDCA) applies to real life
processes and systems,
not to systems of documents
panderingto the requirements of ISO 9001.

by T. Dan Nelson

Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

A QMS is composed of processes impacting an organization’s ability to fulfill customer requirements.  Two types of processes  compose a QMS: core processes (or primary, realization, or operational processes) and support processes.  Core processes. in a sense, define what an organization does for a living, while support processes are in place to help assure the effective, efficient operation of the core processes (like a training process).

Dec 16, 2014

FDA New Guidance on Informed Consent: Updates to Required Elements

by Paul Cobb
Clinical Research Associate, IMARC Inc.

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.   
While the new guidance is, in many ways, an expansion of current practices, there are several aspects that are noteworthy. It’s important to consider the evolution of FDA thinking regarding Code of Federal Regulations (CFR) required elements of informed consent. (21 CFR 50.25)

Dec 11, 2014

How to Address the Top 3 Supplier Management Issues

How to Address the Top 3 Supplier Management Issues
Do you spend time juggling your suppliers? 
Your suppliers should have the systems in place 
for satisfying your quality and regulatory needs. 

by Matthew M. Lowe
Executive Vice President, MasterControl Inc.

Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

There are a lot of contract manufacturers that are shifting their focus to medical technology due to the stability of the marketplace as compared with the automotive or aerospace industry. While many of them have good intentions, they often don’t understand the complexities of med tech manufacturing.  

Dec 9, 2014

Five Common Issues that could Jeopardize Training Compliance

Editor, MasterControl Insider

If your company is regulated, then you know that it’s not enough to have your quality standards on paper. You have to implement and integrate them into your daily operations and prove to regulators that your standards and policies work.

“Training is what helps turn the theory of quality into reality,” said Dave Hunter, product management director at MasterControl (1). “Effective training should be a fundamental part of a company’s quality management strategy as it can help prevent many quality problems from ever occurring.”

Dec 4, 2014

Two Keys to Prosperous B2B Customer Partnerships

Two Keys to Prosperous B2B Customer Partnerships
Extraordinary quality management begins with
 remarkable people working together to generate an 
atmosphere that stimulates customer success.
by James Jardine
Marketing Communications

Give the customer what they want. It may be a trite and simplistic aphorism, but it’s one that’s hard to live by in a competitive business world. Yet the companies that stay true to it are always the most successful. That’s because a company that provides products and services to other businesses is only as valuable as the value it supplies. Think of it this way: ‘why’ a company does what it does is even more important than ‘how’ the company does it or ‘what’ it is actually doing.

To create value in the (often highly regulated) realm of quality management systems, one software and services provider has made remarkable strides by concentrating on two core values: customer success and exceptional people.

Dec 2, 2014

A Bipartisan Success at Getting Drugs to the Pharmacy Faster (and Cheaper)

U.S. Food and Drug Administration

Most medications used to be expensive – much more expensive than they are today. As recently as the early 1980s, most important drugs on the market were brand names under patent protection. Generics were uncommon; the cost of developing and marketing them in competition with the big brands was too high. Without change, the relative ease with which most of us get and use prescription drugs today might have been quite different.

Change came in the form of the Hatch-Waxman Act, the law – its 30th anniversary is this year – that established the modern system of generic drug regulation in the United States.  Its original sponsors, Rep. Henry Waxman (D., Calif.) and Sen. Orrin Hatch (R., Utah) brokered a critical bipartisan compromise to ensure the bill’s passage.

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.