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  • Mattie718 replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 6 years, 6 months ago

    In the medical device industry there are countless things which need to be documented according to the FDA which may seem monotonous but are all the same mandatory. My company was audited by the FDA for several weeks and they were asking for all sorts of different documents and justification evidence for certain decisions. If you do not have these readily available then you could be hit with a violation and forced to come up without some sort of response to satiate their demands or risk complete production shutdown. Other times you may have documentation but it is done so poorly that you cannot understand why people did the things they did, and it is too long a time period ago that nobody remembers what happened during the project either. This can all get you in trouble if you have inadequate or missing documentation. While the FDA has good intentions it can seem excessive and annoying sometimes but engineers need to remember how important it is to log everything.