New Developments in IEC 60601 Amendment 1 & Risk Management: Part 2

Medical manufacturers live in a world where  regulatory compliance must always be considered,  including changes associated with IEC 60601. ...

Inspecting Clinical Trials - MHRA on the Trial Master File

Does your trial master file (TMF) look  like this?  It doesn't have to if you  move to an electronic system. by Gail Francis Expert Ins...

Infographic: FDA Inspections By The Numbers

During the last 15 years, FDA has gradually  ramped up the number of annual inspections. by Tony Chen CEO and Co-Founder of FDAzilla Up un...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...

Get Products to Market Sooner by Systematizing Quality Cycles

Getting  a product to market is not a one-time event—it involves a series of cyclical processes. Is every phase along your organization’s o...

4 Reasons Why Document Review is Crucial to Compliance

When was the last time you reviewed  your quality documents? by Cindy Fazzi Editor, MasterControl Insider When was the last time you reviewe...

Cosmeceuticals: the Good, the Bad and the Ugly

What is a cosmeceutical?  Is it a lotion,  a shampoo, shaving cream?  Or is it something else? By William L. Schwemer Since retiring from ...

The Bright Future of Quality and Compliance

Quality and compliance are  standing at a crossroads. by Craig Gygi Executive Vice President, Operations MasterControl Quality and complianc...

The ISO 9001:2015 Change Train is Gathering Steam

Big changes are coming to ISO 9001.   Prepare to jump on this change train! by Robyn Barnes Marketing Communications, MasterControl ISO chan...

Creating a High Performance and Low Risk Work Culture

The best articulated corporate vision and strategy  is of no value if it cannot engage the hearts, minds  and work habits of employees at al...

Cut through the Clutter: Simplifying Regulatory Compliance

Cut through regulatory red tape to improve quality, compliance and time to market. by David R. Butcher, Marketing Communications, MasterCon...

Risk: 2015’s Most Valuable Player?

In 2015, risk may become quality's most  valuable player and could drive quality to a  new level of proficiency. by Marci Crane Marketin...

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling  your compliance efforts? Learn how  to fix seven common document  management mistakes. by James Jardine...

6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

Optimizing their QMS will help companies  in  FDA  and ISO  environments realize maximum value  in their compliance efforts . by David R. Bu...

Measuring Risk Management Outcomes

Being a risk manager in an organization  is a  thankless task---but you already  knew that, didn't you? by Rod Farrar Director, Paladin ...

What Does Risk-Based Monitoring Mean for QA Auditing?

What does risk-based monitoring mean for quality  assurance teams who audit clinical studies? by Laurie Meehan I nternal Project Manager, Po...

Risk Management: A Primer for Lean Quality Assurance

Managing risk across an organization is now a critical skill  that should be fully integrated with other business functions  such as financ...