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 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...

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...

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...

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...

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...

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...

Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

Can't find the right lid for the barrel?  You might find  a different lid that almost fits and use duct tape. But if  you do,  chances a...

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...

The CAPA Detective

In the GMP world, the CAPA investigator  is the detective, identifying how and  why manufacturing defects occur. by Laurie Meehan Social Med...

Education And Corrective Actions: The Solid Foundation Of Food Safety Culture

A good food safety culture really means that  everyone within your organization shares  the same mindset, values, ambitions,  and practices ...

Why a Zombie Apocalypse Would Be Unstoppable with a QMS

Would zombies be more successful  at world domination if they used an  electronic quality management system? by Marci Crane Localization Man...

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...

CAPA and Root Cause Analysis for the Food Industry

Can you find the root cause for the chaos in this kitchen?  Unless you identify the root cause of a problem, you cannot resolve it.   By Dr....

Change in Pharmaceutical Manufacture

Change, planned or unplanned,  is imperative in pharma manufacturing. by Peter Murray,  C onsultant 1. The concept of change Within the phar...

How to Tip Off a GCP Auditor in 25 Words or Less

"Jane, quick!  The auditor's here!  What's an SOP?" by Laurie Meehan Social Media Manager Polaris Compliance Consultants “...

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...

FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

Does the word "audit" make you shake in your shoes? by Ken Christie COO, VTS Consultants, Inc. If there is one word within the lif...

CAPA Should Not Be a Dreaded Four-Letter Word

A poorly maintained paper-based CAPA  process may contribute to FDA violations. by Cindy Fazzi Editor, MasterControl Insider In a regulated ...