Validating the as is process model Dating sites lovedate com
Regulatory authorities recognize the critical nature of a sterile barrier system.
In fact, they consider packaging an accessory or a component of the medical device, which implies that the package system is nearly as important as the device itself.
In software project management, software testing, and software engineering, verification and validation (V&V) is the process of checking that a software system meets specifications and that it fulfills its intended purpose.
It may also be referred to as software quality control.
If such artifact is incomplete or wrong, the developers will not be able to build the product the stakeholders want.
In addition, packaging often has a direct function in the application of the treatment; for example, it may act as a fixture or a dispenser.
Therefore, mechanical damage to a package cannot be tolerated.
TESTING A medical device's package plays a key role in safely delivering treatment to patients.
It must ensure the integrity of the device from the point of manufacture to the point of final use.