The 9 Most Common Validation Problems


What validation problems are you likely to see over and over? When tackling complex validation challenges, you’ll save time, money and headaches when you know the most common problems and where to find them.
The following analysis is based on validation work EduQuest performed for a large FDA-regulated company over the past year. The goal was to bring the company’s software validation evidence up to the level of the U.S. FDA’s current expectations as well as those of the client’s own independent auditor.
Our efforts yielded 1,720 observations. As part of a “lessons learned” review, we categorized the observations and identified which documents contained them. The results – in our experience – are typical of the problems most companies face.

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Can anyone explain this in another way? Don’t quite understand what it is trying to say, or maybe it’s just me:(.

also the documents mentioned in the article, isn’t that all the documents required in the validation? What else are there?

I think not having total Understanding of the process before carrying out the validation is the most difficult problem in validation.

Always understanding of the process, what does your process do, what are the variables of the process and their impact on the process, how is your process being controlled etc. is a critical one. The first requirement of the validaiton is understanding of the process and I think incomplete understanding of the process is the most difficult one in validation.

Suppose, in a drying process of granules in a Fluidized Bed Dryer, you consider drying time, inlet temperature, outlet temperature, air velocity for fluidization of granules, particle count and microbial count of the air as variables for drying process, but you did not consider the drying load and dew point of the air used for drying as a variables then your validation will not be a robust one and all of your efforts done in validation will go in vain.

I consider the understanding of the process before validation is the most difficult one.