This whitepaper will first give you insights into which guidelines are applicable, in which setting, and how to comply with these guidelines. A comparison will be made between the different fields and how GAMP5 can be used to comply with each of these regulatory frameworks.

Across different environments – clinical (GCP), laboratory (GLP), or manufacturing (GMP) – there are various regulations and guidelines to adhere to for effective computer system validation. Organizations can use these as a framework to ensure compliance and guide their application of these standards.