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hruship101 replied to the topic Importance of Logging Work in the forum Project Management Process and Medical Device Development 9 years, 3 months ago
During one of my co-op experience, I worked with the design and instrument validation of many measuring devices. As a result, I was involved keeping critical notes on file because validation of a device is not something that can be finished easily without running multiple variations of the tests. Many times, I had to refer to my own notes to see on how the specific test was performed and outcome of the test. Because of this log keeping, I was also able to describe my tests ran and the results to the weekly team meetings without any confusion. This has also helped the company during any regulatory audits. For example, if FDA comes in for an audit and request the specific device validation protocol, the auditor will see the step by step procedures on how the machine was validated. This will limit the auditor from asking questions. All in all, it is really important for a company to keep track of design validation as well as project completion by logging in the work as it helps the individual looking at it and the company in making the best decisions in the future.