Companies that have less than <$5 million in annual revenue have 24 months to start the compliance process and then their clock resets to an additional 36 months to complete the rest of the process. My company is comprised of all ex-pharma people and we agree that the best step, and the easiest step, is for manufacturers to start documenting their process. The FDA mantra is, if it isn't documented, then it wasn't done and this will really help companies. For an intro to the compliance process, click here.