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krp76 replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 8 years ago
Although I do not have personal experience with FDA audits. We are always reminded to adhere to the protocols set forth because they are in place as safeguards for if/when audits do occur. Employees at our company are constantly trained on proper documentation and record keeping of all data and communications so that there is full transparency during any potential audit. Through my experience when I asked my managers about audits, they explained that if there are any small details missing, as Dr. Simon mentioned in his lecture signatures on certain forms, then the FDA would go through a fine tooth comb over the rest of the project in detail. Essentially even the smallest mistakes can prove costly in audits and that is why there is meticulous rules/training on record keeping of all data/communications.