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dipanpatel replied to the topic Validate or Not in the forum Device Documentation 7 years, 1 month ago
The FDA provides guidelines on validation processes with the purpose to ensure varied inputs lead to consistent and high-quality results. The process is tailored to each device. The customer and user need to be complied with. The safety and outcome of the device need to be known and most importantly clarity of the thought and instructions. Learning and preparing the validation processes initially is the most difficult but protocol can be followed by a trained or new engineering with some mentoring. As a new employee, the best way to learn was to get some initial guidance from trained professionals and then to follow documentation yourself and learn through doing. Even though this was true for more manufacturing/testing part of the job, it can be carried to all aspects.