Installation/Operational Qualifications and DoE

I will review your equipment manual and meet with you to understand your business requirements, and then develop a customized IQ protocol that meets compliance needs and mitigates business risk. 

The (DOE) is an often skipped critical step for optimal processes and Operational Qualification (OQ) high/low settings.  I design customized DOE studies, analyze the data, and provide recommendations, including high/low settings for OQ.

I will incorporate the settings from the DOE study into an OQ protocol that includes high and low settings, slightly exceeding the normal operational range of the equipment. The result is a robust OQ, ensuring that the equipment or system can operate under a wide range of conditions and still meet all performance requirements.