Computer System Validation

Validation of computer systems is the process of quality assurance, based on adequate documentation of processes, ensuring that a computer system meets the requirements, consistently, in a given operating environment.

This approach is crucial for industries subject to very high quality requirements, such as pharmaceuticals and medical, in all cirsconstance as those required by European or American regulations (FDA, EU?).

Pops Cube meets these requirements verification and validation of deliverables throughout the lifecycle applications. It requires, in addition, the use of a rigorous testing methodology including traceability from test specifications specified by the system itself.

The starting point of any validation worthy of the name is the risk assessment for each use.