GxP Lifeline

Enter The Digital Risk Officer

In the brave new world of digital risk management, a CISO would report up to a DRO who manages risk from a business perspective and works with peers in business operations, compliance and IT security.

Risk Management: A Primer for Lean Quality Assurance

In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

Enjoy a Quality New Year!

Stedman Graham Steps Out of Oprah’s Shadow, Shares Secret to His Success

Stedman Graham, CEO of S. Graham and Associates and a best-selling author of motivational books, shared the secret to his success. No, it’s not Oprah, though he’s widely known for his long-time relationship with one of the world’s most famous media personalities. 

Have a Quality Holiday Season

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard.  The current FDA guidance regarding biological evaluation of medical devices,

Basics: Documenting a Real QMS

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.

FDA New Guidance on Informed Consent: Updates to Required Elements

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process: 

How to Address the Top 3 Supplier Management Issues

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.

Five Common Issues that could Jeopardize Training Compliance

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.

Two Keys to Prosperous B2B Customer Partnerships

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.

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

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.

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

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.

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.

Recognition is a Good Thing

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

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

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.

American Laboratories Begins Phase II of MasterControl

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.  

MHRA Opens One Stop Shop for Regenerative Medicine Information

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.

MasterControl Says “Go Live” to Localized Websites

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.

Surviving ISO 9001: 2015

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.