Establishing documented evidence that provides a high degree of assurance that equipment or facilities will perform to the required specification detailed in the user requirement specification and the design qualification. 


Related articles

FAT, SAT & IQ

A Factory Acceptance Test (FAT) is a process that evaluates any bespoke or customised equipment duri...

Read more

OQ & PQ

Operational Qualification (OQ) is a documented program to demonstrate that the Cleanroom, when opera...

Read more

GMP Requalification

Ongoing Performance Qualification requires a repeat of the initial testing on the cleanroom to ensur...

Read more