Version 5 of the Good Automated Manufacturing Practice (GAMP) guide (1) was released last year. This publication has been available since 1994, when version 1 was informally published in the UK, and since its inception it has always contained a classification of software. This is one of the ...
GAMP stresses the use of critical thinking and risk-based assessments to justify the testing approach of a software tool. Its guidelines are widely supported by regulatory agencies and are used globally by regulated companies using computerized systems for compliance and validation. What is GAMP®5?
Endress+Hauser participated at Copenhagen, Denmark on April the 7th and 8th, 2008 at the ISPE congress for launching the new GAMP5. The new guidelines, rules and recommendations will be integrated into our quality system. Training sessions and re-certification are planned for our management, indus...