Qualification produces the documented evidence that an appliance or a system fulfils the previously specified requirements.
A lot has changed in the world of pharmaceutical industries in the last two decades.
Computer system validation is a key element because it ensures all the IT applications fulfill their intended purposes.
It is important that the instruments are calibrated frequently, but unfortunately, there is no straight answer for how often they should be calibrated.
Different instruments have different calibration needs, and they cannot be calibrated every time an instrument is used because of cost.
When the instrument does not perform within the acceptable range of error, its quality will be greatly affected.
Calibration guarantees the quality is not affected by constant errors.