The FDA is a federal bureaucracy, and the "picky" requirements are the usual and customary mode of operation. Documentation of details is important in order to

The FDA is a federal bureaucracy, and the "picky" requirements are the usual and customary mode of operation. Documentation of details is important in order to conform to federal law which the FDA implements in its domains. Having been involved in several pharmaceutical studies, I can assure you the level of documentation detail demanded is extremely picky. Medical laboratory rules are similarly strict. They have to be given the risks to patients if not closely regulated. The essence of the requirements are thoroughness and consistency. Medical laboratory measurement devices have to be carefully calibrated in order to be predictable, a lot rides on the accuracy of results. Without conforming documentation of calibration and testing procedures, it's impossible to trust lab test results, which is untenable. It's not "just red tape", if true that compliance with standards is arduous. I have no trouble understanding reasons people might avoid getting involved in biotech enterprises, or recommending it for others.