Our team enabled our client to become compliant with both company and industry requirements. Custom equipment was purchased by our client based on the User Requirements Specifications and Functional Requirements Specifications documents developed by the engagement team, in collaboration with the equipment manufacturer. This allowed for the creation of a fully automated production process. The team efforts also allowed our client to bring a robust manufacturing process online to produce a functional product with no product stock shortages or market disruptions.
Our client underwent a subsequent FDA inspection, in which the developed process was reviewed, with zero FDA Form 483 observations.