The Project Management Institute (PMI), an international professional organization, has developed an internationally recognized certification whose goal is to build and share knowledge on all aspects of Project Management.

The GAMP (Good Automated Manufacturing Practice) guide describes a set of principles to provide documented evidence in order to ensure that customers’ requirements and regulatory standards have been fully complied with. The qualification and validation documents, in accordance with GAMP 5 and IEEE 829 requirements, meet official regulatory agencies’ requirements (ANVISA, FDA, EMEA).