Computer System Validation (CSV) in regulated operations provides confirmation by examination and provision of objective evidence that computer system validation specifications conform to user needs and intended users, and that all requirements can be consistently fulfilled.

Good computer system validation requires planning, verification, testing, traceability, configuration management and many other aspects of good software engineering, that together help to support a final conclusion that software is validated.

Computer system validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. In practice, computer system validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled.

Please feel free to contact Premier Validation with any computer system validation queries you may have.