I currently work at a company making highly FDA regulated software. We once missed a contract with a big drugmaker due to lack of documentation and QA process standards. The pendulum then swung the other way towards waterfall, to the point where people would write 50-page reports about transferring a database schema from MS SQL to Firebird without mentioning that fact that all the databases had the same username and password sitting in the Registry of the client computers that connected to it for everyone to see. (obviously not anymore). To remove a nonfunctional form field I was once asked to fill out 20 pages of documentation (before I threw a hissy fit and some process Nazis left the company)