Blog

News

10 CAPA Tips for the Medical Device Industry

January 27th, 2016 by

Male Scientist Using Medical ToolsThe CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements ([...] Read More

Dealing with FDA Warning Letters Before They Become a Problem

June 23rd, 2014 by

FDA Warning LettersMost life-sciences firms would agree that the best way to prepare for FDA Warning Letters is to take measures that prevent them from ever coming. Unfortunately, regulatory compliance is a complex beast, and it’s rarely possible to do everything perfectly.

Comprehensive compliance [...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

While it would be nice to prevent such issues [...] Read More