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Agnieszka replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 8 years ago
There are many reasons why tracking time is an important practice for any company or organization. Some include: 1) Following the progress of the project, how much time is needed to complete a certain task, is this time spent wisely, any unnecessary time wasted, can time management be improved? 2) Determining cost of the project, how much should we bill customers, how is time translated to the value of the work? 3) Insights into estimates, completion dates. 4) Insights into employee wages, do they deserves bonuses or raises, keep discipline. I agree with all previous posts that say proper time tracking can ease FDA audits. The FDA is trying to make sure employees are being payed for the work they have put-in, that there is no fraud. Also that paying consumers are not being cheated; i.e. a company claiming compensation for 3 hours of work when only 1 hr was spent on creating the product. Today’s employees have more fluidity in their work schedules therefore proper time tracking can become more careless so stricter regulations should be in place. This becomes even more important in med-tech markets where products have direct effect on the welfare of the user.