Hi All,
I was wondering if anyone knew of the concept of a Holistic Qualification/ Holistic Approach for Qualification, I know by definition it is done at the user site and it involves the entire instrument and software system. I was wondering if anyone knew more about the type of qualification approach and when could it be done.
Chris
I have heard of holistic qualification before and from my understanding, it is the approach of qualifying a process by qualifying its individual parts. For example if you wanted to qualify a production line of some tablets in a bottle, all of the steps between would need to be qualified first such as: the bottle cleaner, bottle filler, tablet press, capping machine, laser etching machine, labeling machine, and the packing machine.
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.
Hi Chris!
The ideas of the holistic engineer embodies the point of view than an engineer needs to consider the whole system, the body of work that makes a product successful. The engineer participates in each phase of product development and is explicitly tasked with making a product succeed. Thus, the holistic approach involves product management/product cost, project management, rigorous communication, marketing, etc. As mjf34, the holistic approach involves qualifying the individual parts of a process.
Hm, this is interesting because I thought all validations were essentially a holistic approach. You don't really validate just one aspect of the product but everything that will touch/create it so in a sense it is always holistic no?
