Cleanroom monitoring system qualification made easy

A step-by-step guide to the required activities leading to the qualification of a cleanroom monitoring system as per the right-hand side of GAMP 5 V Scheme. In conversations leading up to establishing an online particle monitoring systems, most cleanroom users mention the following request for their User Requirement Specification (URS) document: IQ, OQ and PQ will be provided by the supplier. The acronyms stand for installation, operation and performance qualification, respectively.