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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