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...

Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness

    Effective document control software systems give companies the ability to readily track and review document revision and approval his...

6 Ways Quality Managers Can Build a Culture of Quality

Agreeing on a definition of quality is just one way to foster a culture of quality in your company. by Beth Pedersen, Marketing Communicat...

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...

6 Lessons that Quality Managers Can Learn from ‘Star Wars’

by David R. Butcher Marketing Communications, MasterControl Beginning with A New Hope nearly 40 years ago, characters in the epic  Star War...

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...

Streamlining CAPA Processes: Manual Systems vs. Automated Solutions

by James Jardine, Marketing Communications, MasterControl The real challenge in managing corrective and preventive actions (CAPA) isn’t...

10 Halloween Costumes that Will Inspire Quality Professionals to Communicate Even More Effectively with Their Executives

by Marci Crane Marketing Communications, MasterControl Employment pundits say in today’s job market, it’s not enough to have skills and educ...

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...

FDA Requests Public Input on Quality Metrics Guidance

Which quality metrics are you tracking  for audits and inspections?  The FDA is seeking input  on the types of data that contribute to a ...

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...

7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

Human error is responsible for more than  80 percent of failures and defects.  by Ginette Colazzo President of Ginette M. Collazo, Inc. Huma...

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 ...

Closed-Loop Quality Management: Connecting the Value Chain

Quality management must extend  beyond the manufacturing environment. by James Jardine Marketing Communication, MasterControl An increasing ...

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...

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...

Five Steps to Building Process Efficiency with Your Supplier

As supplier activities become more complicated,  there's a new role for a supply chain liaison consultant  who can facilitate activities...