The FDA quality system regulations seem like nitpicking on their face, and they can be implemented in such a way that is very pedantic, but at their core this i

The FDA quality system regulations seem like nitpicking on their face, and they can be implemented in such a way that is very pedantic, but at their core this is really about an engineering process that is controlled and validated, which isn't, you know, unreasonable if you're talking about products that directly impact people's health. 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. 1: http://articles.latimes.com/1999/oct/01/news/mn-17288 http://articles.latimes.com/1999/oct/01/news/mn-17288