ISO 13485:2016 What are the Changes About?

The 2016 version of ISO 13485 was published  in February 2016. Become familiar with  the standard's  changes so your  products stay on t...

How to Ensure You are Following the ISO 9001 Certification Process

These tips help ensure you are  following the correct processes  for successful ISO certification. by Stuart Patch Content Writer Compass As...

5 Lessons I Learned from a Successful ISO 9001:2015 Certification Audit

Effective risk management requires an  in-depth and sometimes painfully honest assessment  of your processes and your areas of risk.  by Lil...

Holistic CQMS: The Modern Model of Clinical Trial Management

Best clinical quality management practices  can only be achieved when an overarching  culture of quality exists organization-wide. by Jam...

Still Using Paper for Audits? Here’s Why You Need to Automate

How much time do you wast manually reentering  audit information?  Software solutions can  profoundly affect your audit efficiency. by Steve...

What Do You Do? A Short and a Long Answer

MasterControl helps regulated companies  adopt a closed-loop quality management  system (QMS) that greatly accelerates their  compliance and...

Multipurpose Tool vs. Best-of-Breed Platform: How to Tell the Difference

Beware of a multipurpose tool that claims to be a  best-of-breed quality management platform.  See if the software addresses six critical qu...

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...

It’s Hot in Here—Quality, Compliance, and Romance

Whether in quality systems or in life,  don’t fall for the gorgeous bad boy.  Aim for long-term compatibility. by  Cindy Fazzi Editor, Maste...

5 Tips for Winning Executive Buy-In for a New QMS

These five strategies will help convince  the executives and departments in your  organization to support your proposal f or a  new EQMS or ...

A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences

When quality and compliance are incorporated into  operational  excellence strategies, companies are able  to thrive in the competitive l...

3 Keys to Driving Collaborative Growth in Life Sciences

Life science companies are being  frustrated in their attempts to bring  higher quality products to market. by James Jardine MasterControl ...

Infographic: How Evolved Is Your Quality Management System?

Is  your QMS primitive, civilized or somewhere in between?  By: Lisa Weeks, Marketing Communications, MasterControl Quality management syst...

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...

The Perks of Pursuing a Career in Quality Management

Don't fear the auditor!  Instead, become one!  Auditing can  lead to a variety of career paths in an organization. by Greg Peckford Foun...

Getting Ready for ISO 13485:201X (Part 1)

The quality management standard for med devices is changing. by Lisa Weeks, Marketing Communications As most of you know, ISO 13485–Quality ...

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...