Posts Tagged ‘Corrective and Preventative Actions’

CAPA Systems Based On The TQM Model And Federal Regulations

  Over time, the concept of Quality Control has evolved to become Total Quality Management (TQM). According to Wikipedia, the concept of TQM “…consists of organization-wide efforts to install and make a permanent climate in which an organization continuously improves its ability to deliver high-quality products and services to customers.” Since a CAPA system is […]

What Are CAPAs And Why Are They Important?

  In a handful of upcoming blog posts, we’ll be discussing a hot topic in our industry, along with a complementary piece of technology that might surprise you. The term Corrective and Preventive Actions, more commonly known as CAPAs, refers to an elaborate combination of processes and procedures used to maintain compliance with the following […]

FDA Warning Letter Trends Show That Medical Device Companies Need To Improve These 3 Things

U.S.-based Medical Device companies, take note: Between October 1 and December 23, 2014, the FDA issued 11 FDA Warning Letters to your peers. With an average of almost one per week, it’s clear that medical device companies are BIG on the FDA’s radar right now. While the Letters touch on nearly every aspect of the […]