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Right now I'm doing a lot of research into GxP for a life sciences project I'm working on. Quoting something I found online... "GxP is an acronym that refers t
by pugworthy 7y ago
Right now I'm doing a lot of research into GxP for a life sciences project I'm working on. Quoting something I found online...
"GxP is an acronym that refers to the regulations and guidelines applicable to life sciences organizations that make food and medical products such as drugs, medical devices, and medical software applications. The overall intent of GxP requirements is to ensure that food and medical products are safe for consumers and to ensure the integrity of data used to make product-related safety decisions."
I would guess that the GxP mindset is lacking in a lot of these projects, and in truth it would be a burden to progress to be full in on it.
But that said, I do hope people who are doing these things are at least aware of the importance of data integrity and a very good log of their work. Don't just record what works, but also record what doesn't work. If a motor, or an Arduino, or any other part fails on you or you find that using a cheap one leads to issues, this is REALLY important to record and note for the record. This is especially true for anyone attempting to duplicate your work.
That said, it's worth noting that the site specifically states that...
"We are working to submit a specific variant of the MIT E-Vent design to the United States FDA for review under the Emergency Use Authorization (EUA) authority."
and
"The Department of Health and Human Services (DHHS) has declared liability immunity for medical countermeasures against COVID-19."