The validation is based on requirements and risk analazis with focus on end user risks. 

Low risks should be handled outside validation in normal quality control system. 

In some cases, the output can checked using expanded inspection and then do a retrospective PQ later. It is very important to include the production site in validation activities, as they have to maintain the validation onwards.

To reduce the PQ activities, the final products should be divided into groups.

1st RA


DQ gives input to URS


2nd RA after supplier quotation including process description


3rd RA after Design Review


DQ Report


IQ Protocol


OQ Protocol


WCA Protocol incl. plan for DOE

PQ Protocol


FAT and SAT can be prepared for validation activities


Establish Change Control


IQ Report


OQ Report




WCA Report


PQ Reports