Have any of you worked at a GMP facility…any facility??? Or do you just sit in front your computer all day answering questions you don’t know a thing about.
Okay enough of that I feel better now. In a nutshell Validation is a testing process that can be applied to computer systems, equipment cleaning processes, manufacturing processes, analytical test methods, etc. Health authorities and GMP regulated companies have developed validation processes with a specific purpose: to provide Quality Departments a process for documenting that a system can and will give results that are CONSISTENTLY within PREDETERMINED requirements.
Qualification is a lower level but yet integrated process involving the testing of computer software Hardware, infrastructure, Laboratory equipment, etc. Performing qualification on a piece of equipment provides documented evidence that the equipment can function properly and can perform all the tasks you want it to perform.
Qualification and validation are related even though there are two separate Concepts. In a way qualification is a part of validation-- an area cannot reach a validated state without good qualification of all the individual systems that make up that area. Validation differs from qualification though, validation is a much more complex process that involves more time, resources, and money.
I could talk about this all day butt you’re likely not going to understand it just reading. There is a reason why you didn’t understand a word of what you read before you word vomited on this forum… I’ve been working in big Pharma quality over 10 years and it took me a long time to understand these Concepts. Validation is no little BS thing you can learn on the Fly to impress your friends. So stop misleading people who may actually be trying to learn something. I’m not trying to complain but there is 22 other responses on this thread. I have read every single one of them and every single one of you is talking out of your butt.