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myton replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 8 years ago
There are a lot of bad things that can happen when improper documentation is done. For example, if you do not create a detailed and completed work log when you are creating a product, it might be difficult for you to get approval on filing a patent and getting ownership rights. Also, when in a company, when you forget to add modifications to a product that you are developing e.g. an extra ingredient or a part, and you release that product and you neglect to add that information to the label, you can cause a recall or possible law suit.