A medical device manufacturer was in need of help installing and qualifying a completely new piece of automated manufacturing equipment to replace aged equipment which utilized a manual process. Our client sought a team with a robust understanding of inputs and outputs to develop specifications for the equipment manufacturer. These specifications would enable them to build the equipment needed in such a way that the subsequent installation, qualification, and validation activities could occur.
To help the client fully automate the production process, obtain the new equipment, and perform the Commissioning, Qualification and Validation activities, our consultant team was responsible for completing the following activities within a seven month period:
- Performing Reverse Engineering studies to correlate manual outputs with automated inputs
- Identifying equipment that would be the best fit for their manufacturing application and resultant product
- Performing Engineering Analysis throughout the Commissioning and Qualification process
- Assisting with outlining User and Functional Requirement Specifications (URS and FRS)
- Drafting and executing all related Computer Systems Validation (CSV), Logic Test Cases and Installation/Operational/Process Qualification (IQ/OQ/PQ) activities
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.