GxP Lifeline Blood & Biologics Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

October 2009

Please Don't Call Them CAPAs

I've long been troubled by the ubiquitous acronym used to refer to corrective action: CAPA. My gut reaction borders on the irrational. Most of you reading this have heard of or read about or used the acronym hundreds of times. And you're probably wondering why the two syllables CA-PA should produce such an extreme reaction - especially in someone who spends a great deal of her time teaching people about both corrective action and preventive action. The short answer is simple: They're two separate processes that have been mashed together resulting in a diminution in the effectiveness of both.

Read more

Avoiding the CAPA Calamity

Anyone working in quality management is familiar with references to "Death by CAPA" or "CAPA Kills." The industry is rife with similar catch phrases. The "truth" is they are not far from the "truth." When my friend from FDA originally coined the expression "death by CAPA," it was with the best of intentions. Her concern was for those who were killing their respective companies with an overabundance of entries into the CAPA system. These employees were doing so in an effort to ensure all that needed to be examined was always caught. To avoid your own CAPA calamity, let's examine two key distinguishing features of a good approach to CAPA management.

Read more


Featured Webinar:

Featured White Paper:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

AABB Annual Meeting & TXPO 2009
October 24-27, 2009, New Orleans, LA

CAPA Workshop & Regulatory Session
November 5-6, 2009, Newport, CA

GMP & FDA Compliant Quality & Doc Systems 2009
November 19-20, 2009, Munich, Germany

View More Events

Did you know that you can now have multiple people simultaneously author the same Word document in Microsoft Word? The right type of software can now allow document owners to set-up 'EditZones' in Word documents. These zones can be allocated to different contributors who can simultaneously edit their zone in Word while taking advantage of all the application's regular capabilities.

Read More