Verifies that the system is installed correctly—hardware components, software version, utilities, and environmental conditions. “Did we receive what we ordered and install it per the spec?”
Any updates or modifications must be evaluated for their impact on the validated state. guide for validation of automated systems
Crucially, each test must be traceable back to a requirement (traceability matrix). Automated tools can help, but human review remains essential. Any deviation must be documented, investigated, and resolved. guide for validation of automated systems
The following are common challenges and solutions for validation of automated systems: guide for validation of automated systems