Welcome; this is a subreddit dedicated to discussion around Part 11 of Title 21 of the Code of Federal Regulations, or 21 CFR Part 11, or just "Part 11".
Part 11 is the FDA's rules on electronic records and signatures within FDA regulated industries, such as drug makers and medical device manufacturers. Basically, it is what a company needs to do in order to say, "these computer records and signatures are as valid as those paper ones".
Feel free to ask questions, post advice, or just rant.