Guide For Validation Of Automated Systems _best_

Non-configured software (Off-the-shelf software used as-is).

What do you need the system to do? This is the most critical document. If it isn't in the URS, it won't be validated. guide for validation of automated systems

The "V-Model" is the gold standard for visualizing the relationship between development phases and testing phases. Left Side: Specification & Design Non-configured software (Off-the-shelf software used as-is)

This guide applies to all automated systems used in regulated industries, including: guide for validation of automated systems