FDA Compliance Manufacturing Equipment Identification and Installation
Business Analysts Functional Analysts Specification Development Project Management Commissioning and Qualification Validation
Zero FDA Form 483 Observations.
A medical device manufacturer was in need of installing and qualifying a completely new piece of automated manufacturing equipment to replace aged equipment which utilized a manual process.
Our client sought a partner with a robust understanding of inputs and outputs to develop specifications that would be provided to the equipment manufacturer in order to build the equipment needed so that the subsequent installation, qualification, and validation activities could occur.
To fully automate the production process, obtain the new equipment, and perform the Commissioning, Qualification and Validation activities, our Life Sciences 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 the client to become compliant with both company and industry requirements. Custom equipment was purchased by the client based on the User Requirements Specifications (URS) and Functional Requirements Specifications (FRS) development documents created by the engagement team, in collaboration with the equipment manufacturer, which allowed for the creation of a fully automated production process.
Our team efforts also allowed the client to bring a robust manufacturing process on-line to produce 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.