In healthcare facilities, pharmaceutical companies, hospitals, pharmacies or laboratories, computerized systems are used to support daily quality-relevant processes. These companies may be subject to legal requirements (AMG, AMBO, GSG, BSG, ...) which require compliance with the following specifications.
GMP Good Manufacturing Practice
GCP Good clinical practice
GDP Good storage and distribution practice
GLP Good laboratory practice
The associated computerized systems (CSV) must be checked for suitability and validated. The Good Automated Manufacturing Practice guidelines(GAMP) have become established as the associated technical standard for the validation of computerized systems.
