Who Computerized System Validation?

Computerized system validation is the process of testing/validating/qualifying a regulated computerized system to ensure that it does exactly what it is designed to do in a consistent and reproducible manner that is as safe, secure and reliable as paper records.

Who is responsible for ensuring that a system is validated and maintaining it in the same state?

Each automated system or device should have both a business owner (of the process) and a system owner (of the computer system) defined; and these individuals together are responsible for maintaining the validation status of the system.

What is CSV in software testing?

Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.