by Our Team | Sep 29, 2021 | Blog Articles, Subscriber Articles
You have just undergone an audit and discovered a gap in your process. What’s the next step? The key to inspection readiness is having an effective CAPA system that not only correct the issues but also prevent them from happening again. Only by identifying the root...
by Kimberly | Sep 15, 2021 | Subscriber Articles
Since the year 2010, the most prevalent FDA audited observations in the medical device business have been “insufficient corrective and preventative action procedures.” Its recurrence as the most common issue year after year indicates that many device firms have...
by Kimberly | Aug 31, 2021 | Subscriber Articles
A corrective and preventive action (CAPA) plan is a set of steps done to address a compliance problem and, more significantly, to keep it from happening again. The immediate noncompliance and the broader nature of the problem will be the subject of a CAPA plan. It...
