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  • ala26 replied to the topic a successful validation process in the forum Introduction to Design Controls 6 years, 5 months ago

    One of the task I had to work on as an intern was validation. The first step for a successful validation is that everyone on the team does their part in a timely manner. For example, the team ensures the IQ and ect is complicated so the validation can be done as soon as possible. Another step to be successful is to look at previous validations or find validations from other sites on the same machine. A lot of times, another site has done the validation on the machine you are about to validate. It will allow you to use their validation as a template. The next step is to pre-determine the statistical aspect of the validation. How many samples will be used? Is it enough to ensure the quality of the machine is good? Utilize statistical programs such as Minitab.