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Hariharan Ganeshan Thevar replied to the topic Work Logs and FDA Audits in the forum Project Management Process and Medical Device Development 6 years ago
Work log itself defines that to maintain a proper record for the product that has been researched, manufactured and various steps involve in the process.
In FDA regulations, the department examines each every record maintained and finds out the error of the product. If any of the record is missed, then the FDA approval is easily rejected.