Verification and Testing: This phase includes various levels of testing, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each test is mapped back to the original specifications to ensure full coverage.

GAMP 5 (Good Automated Manufacturing Practice) is the industry standard for the validation of automated systems in the pharmaceutical, biotechnology, and medical device industries. It is published by the International Society for Pharmaceutical Engineering (ISPE).

Validation doesn't end at Go-Live.