Stop Asking Why

Sometimes the "why" question should be broken into smaller parts. by Harish Jose  Senior Quality Engineer ASQ CRE, ASQ CQE, ASQ CS...

The SCIO Concept: How to Conduct Cost-Effective Clinical Trials

For the past 20 years, the cost of new drug  development has risen at a rate  that was 7.4%  higher than inflation, and clinical trials bear...

Study Sites: Too Many Vendors, Too Little Time

Clinical site employees are dealing with  more tech vendors than ever before,  consuming  time that should be spent  running the study,  wor...

Why We Trek to Trade Shows

You'll see MasterControl exhibiting at  more than 10 trade shows this year.  MasterControl staffers frequently address  industry confere...

Leveraging Quality Management Systems to Visualize and Mitigate Risk at a Cross-Enterprise Level

Learn to use a quality management system at a  cross-enterprise level during the Proactive  GCP Compliance Conference MasterControl Expert A...

How to Explain Your Quality Job to Young Kids in 4 Steps

First-graders learn the concept of quality  through a paper airplane building exercise. by Lillian Erickson Global Quality Manager, MasterCo...

The #1 Cause of Medical Device Recalls—and How to Avoid It

FDA report lists faulty software  design as top recall cause. by Lisa Weeks, MasterControl Communications Would it surprise you to learn tha...

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...

Quality by Design Part 1: You Can't Design Something You Don't Understand

If the cost of poor quality is like an iceberg, the obvious penalties are a lot less scary than what lies below the surface. by Beth Pederse...

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...

The Past, Present and Future of CAPA

Conclusive CAPAs: Experienced market leaders  use detailed risk gateways like the one pictured  here to establish forward-looking, comprehen...

The Case for Quality: Working with Stakeholders to Improve the Safety of Medical Devices for Patients

The FDA is working with a wide variety of  stakeholders  to identify  and promote practices  that will result in higher quality devices. by...

Steak, Peas, and Doughnut Holes

Continuous improvement can lead to great success but your efforts must be focused. Food for Thought about Continuous Improvement by Curt Por...

When Is A CRO Not A CRO? (And why does that make enforcement hard?)

  It looks like a CRO. It sounds like a CRO. But is it really a CRO? by Jamie Colgin Colgin Consulting What do the following types of compan...

FDA Issues Draft Cybersecurity Guidance for Device Manufacturers

FDA has issued a draft guidance medical device  manufacturers should take to address cybersecurity risks. by Jason C. Gavejian, CIP P Princi...

CLIA vs QSR (What You Don’t Know Can Hurt You)

The Clinical Laboratory Improvement Amendments (CLIA)established quality standards to ensure the accuracy, reliability, and timeliness of pa...

One Q & a Lotta A’s about SOPs for Research Sites

SOPs or work instructions--- which does a clinical research site need? by Laurie Meehan Social Media Manager Polaris Compliance Consultants,...

People Don’t Fail, Processes Do

When a situation goes wrong,  look at your process and ask why. by Terry Smith Lean Enterprise Institute Lean isn’t only a mindset. It give...

The FDA Just Called! Are You Ready for an Inspection?

If the FDA calls to schedule an  inspection, will you be prepared? by David R. Butcher Marketing Communications, MasterControl If the U.S. ...

How to Respond to FDA Inspection Observations, Including Those You Dispute

by Martin Browning, President, EduQuest, Inc.  FDA expert investigator and rule-maker for 22 years Although FDA is strapped with limited r...

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. ...

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

Risk management monitoring of production and post-production performance is critical  to help ensure safe and effective devices  in the mark...

Do You Really Want to Be An Executive In An FDA-Regulated Company?

If you don't want a visit from the  Department of Justice, pay attention  to the new enforcement policies  the DOJ is following. by Jam...

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...

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...

8 New Year’s Resolutions for Quality Professionals

by David R. Butcher Marketing Communications, MasterControl ‘Tis the season to set New Year’s resolutions. With 2015 behind us and a whole ...