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Luisa Gutierrez replied to the topic Holistic Qualification in the forum Process Validation and Process Risk 8 years, 1 month ago
Chris,
This is a type of qualification that I have not encountered within my daily work but it is interesting to read about it. I found a few details that show how it can expedite the process a product to market. An example is two companies coming together in a single contract partner to product quickly their minimally invasive laparoscopic surgical device. And the timeframe that includes the development of device to meet product requirements, design manufacturability, passing verification testing and transitioning to full scale production in 6 months. My perspective on this expedited route is that it provides the customer with the device at a quicker time frame and the company can work with various vendor. However, it does provide a large dependability on each individual contributor to the device that if either a vendor is unable to fulfill the high demand or they decide to increase price due to large demand. In terms of the regulatory portion, it can provide an expedited clinical trial which will not provide an adequate testing for the device and can bring up issues later on.