Computer System Validation
OneSource® Computer System Validation assists in the planning and implementation of validating computer systems and ensures validation methodology meets regulatory requirements .
Our services are based on 21 CFR Part 11 and GAMP5 ("risk based" approach & V Model documentation). All validations take into account "intended use" and "environment", which is customized based on user requirements (URS). Validations range from full validation for new systems to change control validation for existing standalone and/or enterprise systems.