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Dr Zuhdi Hussein
By Dr Zuhdi Hussein on March 31, 2021

The CAPA process from the side of regulatory compliance of both U.S. FDA requirements (21 CFR 820.100) and EU regulatory requirements (ISO 13485, 8.5.2) is one of the most important elements of a Quality Management System (QMS). 

It is essential to develop a system the right way to assure QMS effectiveness and minimize irregular findings on regulatory audits.

By Henry Macartney
on June 02, 2014

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.