I'm noticing that you didn't really address the meat of the parent comment, about the requisite complexity in documenting even a straightforward physics experiment.
No, you're not. And that's why you're missing the point that the details ARE the substance.
The voluminous FDA regulations surrounding drug approval are about tracing EVERYTHING about that drug so that when (not if) something goes wrong, you can figure out what went wrong.
Theoretical Example: 5 people just went blind from eyedrops of a drug that has never exhibited that problem before.
Should the drug be pulled from shelves?
If we work backward through the pipeline records and find that the 5 people all share the same batch of eyedrops, yes. If they don't share the same batch, no, but then we probably need to call the CDC as we have a new disease.
But, what's a batch in common? There is the crate that got delivered to the pharmacy--did the drug get too hot and melt some of the conatiner into it? There is the batch that got delivered to the distributor--did a rat or something urinate on the box? There is the batch that got delivered to the sterilizing company (probably gamma radiation for eyedrops)--did they not give it enough dose or did they have a metal obstruction from multiple loads in the facility.
I can keep going further and further back. Was the water in the process supposed to be deionized or sterilized in some way? Did somebody mix up two similar compounds on the line? Did you clean your reactor with the wrong compound? Some drugs are made by cells and your reactor can "drift" over time and you may have to purge it and start over when the drift gets too far.
The regulations demand that you record all of that up front before you can even BEGIN the process of getting a drug approved for use.
In addition, I would like to add that the FDA are actually really helpful once you demonstrate that you are not a clown. However, they get a LOT of clowns on a daily basis and basically have to assume that you are too until you demonstrate otherwise.
> But, what's a batch in common? There is the crate that got delivered to the pharmacy--did the drug get too hot and melt some of the conatiner into it? There is the batch that got delivered to the distributor--did a rat or something urinate on the box? There is the batch that got delivered to the sterilizing company (probably gamma radiation for eyedrops)--did they not give it enough dose or did they have a metal obstruction from multiple loads in the facility.
> I can keep going further and further back. Was the water in the process supposed to be deionized or sterilized in some way? Did somebody mix up two similar compounds on the line? Did you clean your reactor with the wrong compound? Some drugs are made by cells and your reactor can "drift" over time and you may have to purge it and start over when the drift gets too far.
These days we could track every single step in this product supply chain far more effectively with a crypto-based, blockchain approach. It would be a lot more efficient.
The arrogance in the software space (I'm making an assumption here based on your block chain comment) is often mind blowing. Somehow people who created some software (or even more common an IT startup) think they got everything figured out.
I've just seen it recently with a diary company where a friend was working. Company was build from the ground up by an elderly couple, they sold to an investment conglomerate when they wanted to retire. These guys brought in a new CEO, CFO and upper management team all from the tech startup world. So these guys come say, we must change this, that make everything more agile, streamline... When the production manager kwho had been there for >15years) and my friend former logistics and deputy GM said this doesn't work like this, we need to take things more slowly, do one change at the time, they both were let go, who likes a naysayer.
Well 1 year later the company has lost half its value, the investors fired the management team and brought in some people with dairy experience, it's still 50/50 if the company will survive.
The point of this is, the people doing this stuff aren't stupid, there are often good reasons why things are done in a certain way, so stop and listen before being a smug knowitall.
Documenting "what to track and what it should be" UP FRONT is the really hard part.
The goal is to set things up so that when your system scans a QR code for that barrel of "reactor cleaning fluid" and it scans as methanol instead of ethanol the system starts screaming at you.
You can do all the steps by hand with a paper register. Nobody cares what your recording substrate is. However, they do care that it gets recorded in such a way that it can be verified.
And I would say "Someone has a problem and thinks "Oh, I'll use blockchain." Now he has 2 problems."
> These days we could track every single step in this product supply chain far more effectively with a crypto-based, blockchain approach.
You can solve precisely none of the problems with a blockchain approach.
A blockchain might be used to implement a tracing system, but the blockchain is "just" a storage and query layer, not the interesting and hard part of the problem that needs to be solved.
A: If you allow a drug that ends up causing more harm than benefit
B: If you ban a drug that would have caused more benefit than harm.
So making these regulations is about finding the balance between A and B.
The problem is that a type A error causes a huge scandal. Those who took the drug and died are known by name and there is terrible publicity.
But a type B error only causes people who would have died before to still die. Nothing new has happened, and there is no outcry.
So the pressure on FDA to err on the side of never having any type A deaths, while allowing possibly millions of type B deaths is enormous.