Periodically, I like to review the regulations to stay up to date on what is really required. Many times when you are working, you can be easily convinced of false truths from discussions or from people stating false requirements without a proper reference. One of my go-to regulation sections is 21 CFR 820 which is the FDA regulation for Quality System Regulation in the scope of product manufacturing. Although this is meant for manufacturing, it can be applied to any industry or process to produce a quality product. The following is a brief summary of what I believe to be the most important sections of the code but I encourage you to read the full regulation for yourself.