Big Changes for ICH GCP & EU Regulations

Changes are being proposed for international  clinical research, including the European Union.   How and when will they affect your work? by...

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...

A Season for Giving That Lasts All Year

 During the holidays and all year round, a gift from the heart is the best gift of all. by Beth Pedersen, Marketing Communications Speciali...

Using Quality by Design to Improve Manufacturing

Process control and process improvement  are important parts of life cycle management. by Ronald D. Snee, PhD Snee Associates, LLC          ...

Preparing for ISO 13485:2016 Changes

by James Jardine, Marketing Communications, MasterControl As 2015 comes to a close, medical device manufacturers throughout the world share ...

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...

The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most  complex pharma track and trace law ever passed. by David Dills Sr. Consultant, Regulatory ...

How Performance Excellence Helps Broaden the Horizons of Quality

Where is your focus---on the quality of business or the business of quality? by Mickey Garcia, Segment Manager, Medical Devices, MasterContr...

The Mysterious "No Fault Found"

Ferreting out root cause can explain the  reasons behind a "no fault found" condition. by Harish Jose Senior Quality Assurance Eng...

Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

An auditor's goal is to confirm the trial runs  in a way that ensures the safety of the subjects,  protects their rights and generates r...

How ISO 9001:2015 May Preview Upcoming ISO 13485 Changes

ISO 9001:2015 can help medical device  companies anticipate forthcoming  ISO 13485 changes. by David R. Butcher Marketing Communications, Ma...

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...

9 Crazy Cousins You Probably Shouldn’t Invite to This Year’s Thanksgiving Dinner and 9 Reasons You Could Invite SCORM (Compliance) Instead

Consider trading SCORM for the crazy  cousins at this year's Thanksgiving feast. by Marci Crane Localization Manager MasterControl Thank...

The Future of Medical Device Registries

 The FDA believes that national and international device  registries  in selected product areas are the foundation of  our National Medical ...

eTMF Management: Don’t Settle for a One-Trick Pony!

When you search for an electronic  master file (eTMF)  solution, be sure it  is versatile and not a one-trick pony! by Patricia Santos-Serra...

6 Military Skills Highly Valuable to Manufacturers

This Veterans Day, employers should  consider the valuable skills and attributes typically shared by most U.S. military vets. by David R. Bu...

Why Every Business Needs to Make ISO Certification a Priority in 2015/2016

ISO certification may be challenging  to attain but offers many benefits. by Stuart Patch   Content Writer, Compass Assurance Services info...

Training Effectiveness – A Quality by Design Approach

You can provide all kinds of training  for your employees but how do  you measure its effectiveness? By Holly DeIaco-Smith, MS  HDS Consult...

How Donald Trump and/or Hillary Clinton Would “CAPA the USA” if Elected in 2016

Trump and Clinton: "CAPA'ing" the USA by Marci Crane Marketing Communications,  MasterControl Although a long list of candidat...

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...

6 Traits You Should Develop to Become an Exceptional Quality Pro

Those who attend the annual Masters Summit  sponsored by MasterControl learn about  industry best practices and regulations  to help boost t...

MasterControl to Serve as QMS Provider for Another FDA Division

The FDA’s CDER is responsible for ensuring drug  safety and effectiveness in the United States. by Cindy Fazzi Editor, MasterControl Insider...

FSMA: Get Inspection-Ready with These Best Practices

by Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group Although FDA immediately gained increased authority for records...

Trust is Not Just Nice, It’s the Key to Your Success

Best-selling author Stephen M.R. Covey gave  a business case for trust in his keynote speech  at the 2015 Masters Summit in Salt Lake City. ...

Personal PDCA and How I Learned It

Have you applied PDCA to  your self-development plan? by Mark Reich Chief Operations Office Lean Enterprise Institute In 23 years at Toyota,...

How Scary are the Device Safety Requirements in IEC 60601-1 Edition 3.1?

 Yikes! Amendment 1 introduces over 20 new  requirements and 60 modifications. by Lisa Weeks,  Marketing Communications, MasterControl  ...

Risk Takes Center Stage in ISO 9001: 2015

Explicit references to risk appear  throughout ISO 9001: 2015. by Lisa Weeks, Marketing Communications, MasterControl If you’re unfamiliar w...

Quality Audit: The Direct Route to Continuous Improvement

When it comes to public health and safety,  quality is the only way. by Beth Pedersen, Marketing Communications Specialist  MasterControl I...

EDMS Evolution: Automated Document Management as a Differentiator

Companies are now  spending more on automating  document management than any other quality process.  How advanced is your DMS technology? by...