software, services & solutions
GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations
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.