Document numbers? Release dates? This seems more like red tape and nitpicking rather than a substantive challenge to a technology. It's stories like these that guarantee I would never try to start a company in biotech or recommend a friend join one.
Just because standard practice seems unnecessary to you doesn't mean that it doesn't exist for good reasons. To anyone in biotech or familiar with what can go wrong with physical products, your complaints come across as ignorant.
Document numbers and release dates go toward ensuring everyone at the company is working with the same information. Most computer science students learn about the failure of the Mars Climate Orbiter [1] because one team was using feet and the other meters. Guarding against issues like those is exactly what FDA is trying to do.
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.
Good. We're in mutual agreement. Because I or my friends don't want people working on matters of life and death who don't care about "red tape" or "document numbers".
As far as the biotech industry, the funding situation is awful, especially for early companies, and that is a fine reason to avoid this area. Needing to "say what you do and do what you say" doesn't strike me as that much of an obstacle in comparison.
when you have your shit together in the most basic ways, you simply won't have this level of problem.
we used to call people who didn't do this 'rogue traders' and the like. they were looked down on like scum instead of looked up to as role models.